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Interstitial Cystitis: Effect on a Patient’s Quality of Life of the Drug UracystHydrocarbons Transport Systems: Testing Safety Valves

In this essay the writer seeks to explore the condition interstitial cystitis as a research topic, design a research question and project aim and discuss three different methods. Data collection and data management relevant to the project will be highlighted. The writer will discuss critically the advantages and disadvantages of each of these methods


In this master thesis the effects of changing the test interval of the land based safety critical valves have been highlighted


Production assurance: Also referred to as regularity, is a term used to describe how capable a system is to meet demand for deliveries or performance (Norsok Z-016, 1998).

Availability: The ability of an item to be in a state to perform a required function under given conditions at a given instant of time or during a given time interval assuming that the required external resources are provided.

Production Availability: The ratio of production to planned production, or any other reference level, over a specified period of time (Norsok Z-016, 1998)

Failure: Termination of the ability of an item to perform a required function.

Note 1: After failure the item has a fault.

Note 2: “Failure” is an event, as distinguished from “fault”, which is a state.

Failure mechanism: The physical, chemical or other processes which lead or have led to a failure.

Failure mode: The effect by which a failure is observed on the failed item.

Safety system: A system which realises one or more active safety functions

Safety functions: Physical measures which reduce the probability of a situation of hazard and accident occurring, or which limit the consequences of an accident.


Modern production systems are large, complex, automated, and integrated. Failures occur more or less frequently in these complex and large systems. For a production plant, the consequences of failure include high maintenance cost, possible loss of production, and exposure to accidents. It can also lead to annoyance, inconvenience and a lasting customer dissatisfaction that can play havoc with the responsible company’s marketplace position (Croarkin and Tobias, 2007)

So, it is important for the plant engineers and managers to make decisions that can reduce or eliminate the probability of failures or/and their consequences as well as uncertainties in production processes to get better production assurance.

Production Assurance (PA) is introduced by the Norwegian oil and gas industry, which plays a significant role in supporting the decision-making process for managers and engineers dealing with the challenges of meeting various customer requirements as well as production control needs. Therefore, there has recently been a high degree of interest in use of the production assurance concept. (J. Barabady, 2007)

Production assurance (also referred to as regularity) is a term used to describe how capable a system is to meet demand for deliveries or performance (Norsok Z-016, 1998). Production assurance may be quantified by various measures like production availability, throughput capacity, deliverability, or demand availability. The PA concept includes several other concepts, such as reliability, maintainability, availability, and maintenance support performance. Some of these concepts, and their relationships, are illustrated in Figure 1. In the following section, different concepts, of production assurance are briefly reviewed and discussed.

Effective maintenance is necessary to ensure the reliability of plant/equipment. If equipment is unreliable, the profitability of a business can be greatly decreased. Therefore, the benefits of employing the efficient maintenance strategies cannot be underestimated.

Effective equipment maintenance ultimately dictates plant reliability and has great impact on the success and profitability of a Business Unit. There is an increasing industry focus on safety, risk avoidance and environmental awareness, which emphasises the importance of avoiding failure through successful maintenance. As a consequence, maintenance practices often account for an overwhelming percentage of budget expenditure. The financial and safety benefits of employing efficient and effective maintenance strategies for equipment cannot be underestimated.

The Norwegian safety regulations have two kinds of requirements related to maintenance:

  • High level requirements stating that installations, systems and equipment should be maintained in a prudent manner.
  • Detailed and prescriptive requirements for a system or a piece of equipment to be tested or inspected at certain intervals. (The Maintenance Baseline Study; Operation & Maintenance Compendium)
  • Introduction

According to PSAN (Petroleum Safety Authorities Norway) ‘‘Requirements for testing of safety critical valves’’ emphasizes that there should be annual testing of all safety critical valves and intervals for verification have to be established based on; requirements to reliability, knowledge about failure conditions, knowledge about possible consequences from failure conditions, and knowledge about valve characteristics (T.E. Nøkland, H.S. Wiencke, T.Aven ; Identification of safety critical valves – a risk based approach)

In testing of safety critical valves means that production must be shut down, the valve must be closed, pressure downstream the valve is bled off, and pressure build-up is measured.

It has been observed that often these tests are carried out during turnarounds, not influencing production downtime, Even though test are labour intensive, costs related to such test are limited but sometimes the situation is different. Some platforms do not perform turnarounds each year and production may have to be shut down for hours because of these tests. In most cases these shut downs are also affecting other installations. This is of course an expensive operation that the operators want to limit to what is needed to maintain the required safety level; not only because of the loss of production and loss of income, but also because a shut down of the process and manual intervention into the hydrocarbon system has a negative effect on the safety level in it self (PSAN, 2004) ;T. Aven, H.S. Wiencke, T.E Nøkland (2006)

For instance, If we focus on the barrier functions of the valves, and If we prove the same safety level with alternative test procedures or risk reducing measures then we could be able to justify an increase of test intervals of safety critical valves; T. Aven, H.S. Wiencke, T.E Nøkland (2006)

Thesis objective/Problem Statement:

This thesis is a part of RAMONA project which focuses on regularity and deliverability of the Norwegian gas transport system.

In production plants, generally incidents and events occur from both safety-related and technical integrity-related concerns. “Safety integrity related incidents are those endangering harm to people. Working without Personal Protective Equipment (PPE), personal injuries, and fire and explosions are some of the examples that come under safety integrity-related incidents. Technical integrity-related incidents on the other hand, refers to a wide area of technical incidents arising from day to day operations, and those resulting in the possible reduction or loss of daily production’’; see (J. Raza & J.P. Liyanage)

The main objective of this thesis is to ‘‘discuss the effects of changing the test interval of land based safety critical valves in hydrocarbons transport systems’’.

Changing test interval means increase or decrease of the interval period compare to current standard test interval (which is one year) followed by industry.

Working method

Analytical Learning Framework:


Among other factors that had influence on this project in terms of delimiting it in some way, can be mentioned available time, available literature and language skills of author.

1.5 Regulations/ Standards:

This chapter is about different Regulations/standards presented by the authority of the Norwegian Petroleum Directorate (NPD) and the Petroleum Safety Authority Norway (PSA) related to maintenance program and further related to safety critical systems.

The legislation consists of a two parts; resource management or ‘‘Resource hierarchic’’ part and a health, environment and safety (HES) or ‘‘HES hierarchic’’ part; which further display different legislation levels.

In the HES area, the Norwegian Pollution Control Authority, the Norwegian Social and Health Directorate and the PSA (former NPD) co-operate on joint, total regulations relating to health, environment and safety on the Norwegian continental shelf. Hence, the HES regulations are issued in pursuance of the Petroleum Act, the Pollution Act, the Product Control Act, the Health Personnel Act, The Patients’ Rights Act, The Communicable Diseases Control Act and Health related and Social Preparedness Act. The regulations are the framework regulations (Royal Decree), the management regulations, the information duty regulations, the facilities regulations and the activities regulations. Guidelines to the regulations have been prepared by:

Regulations are connected together as shown in figure; Some points related to above figure is explained below.

Acts and Regulations come on the first and second level in hierarchy. Then are the guidelines to regulations for detail explanation and similarly these guidelines showed some specific requirement which is called standards.

->Petroleum Activities Legislation (Acts and Regulations)

For example, Petroleum Activities Act § 9-1 says ‘‘The petroleum activities shall be conducted in such manner as to enable a high level of safety to be maintained and further developed in accordance with the technological development’’

->Guidelines to Regulations

These are guidelines to different regulations relating to management, information duty, facilities and activities under the ‘‘Joint Regulations’’. E.g. OLF (Norwegian Oil Industry Association)g recommended guidelines for the application of IEC 61508 and IEC 61511 in the petroleum activities on the Norwegian Continental Shelf,

->Standards: The guidelines to the regulations often refer to recognized standards as a way to fulfill the functional requirements in the regulations. International Standards like ISO, API, IEC, OLF guidelines, EN and NORSOK standards are often used.

->Industry internal governing documents like ‘‘Testing of safety critical valves in gas/condensate pipeline system’’.

In NORSOK standards Z – 008, maintenance defined as –

“The combination of all technical, administrative and managerial actions, including supervision actions, during life cycle of an item intended to retain it in, or restore it to, a state in which it can perform the required function” (PrEN 13306)

Maintenance includes activities such as monitoring, inspection, testing and repairing. This means, that is all what is required to keep or to get the item or system back into desired operating condition.

According to §7 of The Activities Regulations; the safety functions at all times will be able to provide functions and should be designed so that they can be tested and maintained without impairing the performance of the function.

Similarly under the §32 of the Activities Regulations, it says that ‘’Facilities shall have an emergency shutdown system which is able to prevent situations of hazard and accident from developing and to limit the consequences of accidents, on safety functions. The system shall be able to perform the intended functions independently of other systems’’.

Moreover, the emergency shutdown system shall be designed so that it will go to or remain in a safe condition in the event of a failure which may prevent the functioning of the system.

More specifically, ‘’Emergency shutdown valves shall be installed which are capable of stopping streams of hydrocarbons and chemicals to and from the facility, and which isolate the fire areas on the facility’’

In §44 (maintenance programme) under the Activities Regulations states that the emergency shutdown system should be verified in accordance with the safety integrity levels stipulated on the basis of the IEC 61508 standard and OLF’s Guidelines 070. In addition to that plants which are not included by this standard and these guidelines, the operability should be verified through a full-scale function test at least once each year.

The test should cover all parts of the safety function, including closing of valves. The test should also include measurement of interior leakage through closed valves. Recording of the plant’s or equipment’s functionality in situations where the function is triggered or put to use may replace testing of the plant or the equipment,

The OLF (Norwegian Oil Industry Association) recommended guidelines for the application of IEC 61508 and IEC 61511 in the petroleum activities on the Norwegian Continental Shelf, says that Periodical functional tests shall be conducted using a documented procedure to detect covert faults that prevent the SIS (Safety Instrumented Systems) from operating according to the Safety Requirement Specifications. The entire SIS shall be tested including the sensor(s), the logic solver, and the final element(s) (e.g., shutdown valves, motors). (OLF 070)

In addition, It is recommended to record and analyse activation of SIS functions to include the activation as part of the functional testing. If proper operation and documentation thereof exist for a period, the manual proof test for that period may be omitted. Observe that the spurious activation of an ESV due to a PSD, does not test the entire function of the same valve during an ESD action.

Moreover, In OLF guidelines it is mentioned that, some periodic interval (determined by the user), the frequency(s) of testing for the SIS or portions of the SIS shall be re-evaluated based on historical data, installation experience, hardware degradation, software reliability, etc. Change of interval is handled as a modification. Any change to the application logic requires full functional testing, and shall be treated as a modification. Exceptions to this are allowed if appropriate review and partial testing of changes are done to ensure that the SIL has not been compromised.

3. Basics of valves

Valves are mechanical devices specifically designed to direct, start, stop, mix, or regulate the flow, pressure, or temperature of a process fluid. Valves can be handle either liquid or gas applications; Philip L. Skousen (2004)

Valves are used in pipeline systems to control the flow rate, the pressure, or the flow direction of a fluid. They can turn on, turn off, regulate, modulate or isolate the fluid.

3.1 Valve Types

3.1.1 Gate valves:

Gate valves are designed to operate fully open or fully closed; when fully opened, there is very little pressure drop across a gate valve, and when fully closed there is good sealing against pressure.

With the proper mating of a disk to the seat ring, very little or no leakage occurs across the disk when the gate valve is closed. However, some leakage may occur under very low back pressures. Another positive feature of gate valves is that they usually open or close slowly, which prevents fluid hammer and subsequent damage to the piping system.

The main limitation of gate valves is that they are not suitable for throttling applications. When gate valves are used in throttling applications, the flow tends to have high speeds near the gate seat, which leads to erosion. Also, in the partially open state, the valve is prone to vibrate, which can lead to damage. In general gate valves are more subject to seat and disk wear than globe valves, and repairs, such as lapping and grinding, are more difficult to accomplish.

3.1.2 Ball valves:

This rotational-motion valve uses a ball-shaped disk with a hole bored through to stop or start fluid flow. When the valve handle is turned to the open position, the ball is rotated so that the hole lines up with the valve body’s inlet and outlet. When the ball is rotated so the hole is perpendicular to flow, the valve is closed.

Advantage of ball valve is ease of operation, high flow capacity, and a high pressure and temperature tolerance. In addition, they have the ability to provide fire-safe protection, and they can handle severe service chemicals. Ball valves typically have lower cost and weight, and provide tight shutoff and low stem leakage. They can be adapted to for use in multiple port configurations.

3.1.3 Check valves:

The purpose of a check valve is to allow fluid flow in one preferred direction and to prevent back flow or flow in the opposite direction. Ideally, a check valve will begin to close as the pressure drops in a pipeline and the fluid momentum slows. When the flow direction reverses, the check valve should close completely. Check valves can be of the following types: swing, lift and tilting disk.

3.2 Why Testing of Valves/equipment:

In NORSOK standards Z – 008, maintenance defined as –

“a combination of all technical, administrative and managerial actions, including supervision actions, during life cycle of an item intended to retain it in, or restore it to, a state in which it can perform the required function” (PrEN 13306)

According to above definition, that is all what is required to keep or to get the item or system back into desired operating condition.

In §7 of the Activities Regulations it is stated that Facilities shall be equipped with necessary safety functions which at all times are able to:

a)  Detect abnormal conditions,

b)  Prevent abnormal conditions from developing into situations of hazard and accident,

c)  Limit harm in the event of accidents.

Similarly under the §32 of the Activities Regulations, it says that ‘’Facilities shall have an emergency shutdown system which is able to prevent situations of hazard and accident from developing and to limit the consequences of accidents, on safety functions. The system shall be able to perform the intended functions independently of other systems’’

More specifically, ‘’Emergency shutdown valves shall be installed which are capable of stopping streams of hydrocarbons and chemicals to and from the facility, and which isolate the fire areas on the facility’’

No more than a few decades ago, maintenance function was considered as an unwanted necessity, which is almost impossible to manage. This vision changed with time and maintenance became a separate service that had the centre attention on technical aspects, with the weight on specialization and efficient working methods. More recently, the progress was the realization that there were more efficient ways in terms of optimizing use of the means and more effective ways in terms of achieving the desired results and it was positive cooperation with other operating functions (Internal partnership). (Compendium op&maint. Page 2)

In IAEA-TECDOC-1200 is stated that the purposes of monitoring, testing and other preventive maintenance actions are the detection of the degradation and prevention from the failure of the safety functions of systems and equipment and the assurance of prompt correction and restoration of these safety functions.

PRA/PSA can be used in order to optimize the level of inspection and maintenance activities correspondingly to them and risk.

To evaluate ageing effects of an equipment

Check corrosion

To prevent accidental events and damage

To analyse dynamic degradation and failure mechanism.

To estimate the probabilities of degradation.

To access the consequences of different degradation cases and evaluate their severity according to the probabilities of the worst consequences due degradation.

To perform the risk ranking for each component.

To make appropriate recommendations, based on results in order to improve the operation and maintenance.

To keep regularity flow constant , we need to test valves and other equipment periodically.

To check the reliability and availability of the equipement.

From (Working Document, governing doc.)

3.3 Safety Critical valves:

The emergency shut down system (ESD system) is a safety system that constitutes an important barrier (the ESD barrier). Fundamental tasks for the ESD barrier are to stop streams of hydrocarbons and chemicals to and from the facility, and isolate the fire areas on the facility. To manage to do this the ESD barrier are depending by the functionality of ESD valves. (Sverre Viland, 2004; Identifying Safety Critical valves – A Risk Based Approach)

Based on current industry practice, to define whether or not a valve is safety-critical is determined on an evaluation of the safety importance, i.e. how important it is for safety point of view. Therefore an analysis/assessment is needed to demonstrate how the risk level could be affected to the following failure modes:

  • Valve fails to close on demand
  • Valve fails to close within the specified time
  • That it leaks

To identify safety critical valves; the required analysis/assessment is performed in to three steps:

1 – To Identify and illustrate the functions of the valve

Valve functions that are important to safety are identified, i.e. the functions whose failure could result in an unacceptable risk, e.g. failure to close, leakage through closed valve.

A safety critical valve normally has more than one function, these are as follows:

  • Does it have an ESD or PSD function?
  • Is the valve part of an overpressure protection system?
  • Is it designed to close/seal off the flow in both directions?
  • Is the valve part of a double block and bleed setup?
  • Other functions.

2 – To explain the effects on safety of the above failure modes

.3 – To Classify critical/unacceptable leakage rate through the valve

In the onshore plants, acceptable leakage rates generally set higher than for an offshore installation, the main reason for this is due to lower human risk exposure in onshore plants.

The acceptance criteria is determined on the basis of whether the contribution to risk of a leakage through the valve is acceptable, required some measures or not acceptable. According to the performed analysis of some onshore terminals and gas transportation systems, recommended reference values for leakage rates are established in table:

Leak rate [kg/s] Action
< 0.05 Acceptable
0.05 – 1.0 Perform specific evaluations, Plan for repair.
> 1.0 Not acceptable – repair

Table: Acceptance criteria for leakage through closed valves

The wide range between the lower and upper limits, i.e. from 0.05 kg/s to 1.0 kg/s, is calculated and mainly based on practical considerations. Current industry experience shows that most valves (>99 of 100) satisfy the lower limit requirement i.e. <0.05 kg/s.

3.3.1 Testing Methods:

Testing of safety critical valves can be testing of function (close) or testing of leakage (including interior leakage or leakage through closed valve). The various testing methods are different with respect to the required performance in real shut-down situations.

  • Testing of the function (close) with real shut-down case
  • Testing of the function (close) with plant shut down

This test is not considered complete since the forces acting on the valve body and valve internals are different from the real case. Thus the test does not disclose all relevant failure mechanisms.

  • Partial stroke testing

The main advantage with this test is that one can avoid shut-down of the plant, therefore it is only relevant while the plant it normal operation; but this test is not considered complete because the test does not demonstrate full closure of the valve. Thus the test does not disclose all relevant failure mechanisms.

It is preferred that, a test should reflect the intended function in a real situation. According to industry practice; for an emergency shutdown (ESD) valve, this sort of testing should normally be complete closing of the valve with the system under pressure and in operation.

However, in some cases there may occur unwanted effects of these ideal tests, like economic consequences related to lost production, but also sometimes negative effects on safety and environment.

Based on the industry experience, the optimal system for testing therefore may well be one that applies different test methods, and combinations of tests, in a consistent program, individually tailored to the specific safety critical valve.

Testing methods of leakage through valve

Different testing methods are used to observe the leakage through the safety critical valve:

  • Leakage test through closed valve with full pressure differential across the valve.
  • Leakage test through closed valve with different pressure levels up- and downstream of the valve
  • Leakage test through closed valve, by measurement of leak rates into the valve body/cavity.
  • Leakage test with valve in open position

When we talk about testing of leakage rate through a closed valve; acceptance criteria for leakage rates through the valve at normal full differential pressure across the valve should be defined.

4.1 What are the affects of changing the test interval of safety critical valves?

Changing test interval means increase or decrease of the interval period compare to current standard test interval (which is one year) followed by industry. In usual practical applications testing and inspection is the most relevant and effective means of deterioration control.

The observed failure frequency, together with a criticality evaluation, will be a basis for prioritizing the maintenance work and optimization of test intervals; Aven and vinnem (2007)

In fact cost, the level of risk and the benefits from risk control are closely linked see fig.

We can say increase in benefit from a decision may increase the risk if cost are kept constant or any reduction in risk may reduce the benefits as cost may increase.

  • Test interval for test of function close
  • Test interval of leakage in valve
Test interval> 1 year Test interval < 1 year
Positive effects Negative effects Positive effects Negative effects
  • Save economic cost
  • Reduction in maintenance cost
  • Avoidance of production loss
  • Less number of process shut downs
  • May cause higher risk related to safety level
  • Performance issues
  • May cause higher frequency of occurrence of failure
  • High reliability and functionality of equipment
  • Improved safety level
  • Higher maintainability and availability
  • May increase leakage
  • Maintenance cost increased
  • More production shut downs may affects other installations
  • Labour intensive

Table 1: Different dilemmas of changing test interval of Safety Critical Valve

4.2.1 Discussion:

There are some advantages and disadvantages related to each dilemma; see table 1.

Firstly, we see that current industry practice about testing of safety critical valve which is once a year; is quiet satisfactory. In the Gassco document TEKD-PR-021/5/; is mentioned about safety critical valve that: ’’The reference value for test interval is 1 year. The program may deviate from this, provided that adequate and documented grounds for this are stated’’

There are many critical factors involve in each dilemma.

Followings are the some ‘‘critical factors and their impacts’’ involved in changing the test interval of ESV. Table 2:

Critical Factors
Interval <1 year Interval =1 year Interval >1 year
Failure Probability Very Low Low Relatively high
Reliability Share this: Facebook  Twitter  Reddit  LinkedIn  WhatsApp   

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each methodological approach. The writer will then select one of the methods and justify why this is the most appropriate data collection method to use. The writer wants to develop a project to measure the effect on a patient’s quality of life of the drug Uracyst, on patients suffering from interstitial cystitis pre and post instillation. The writer will look at the O Leary- Sant score as a measuring tool. Background Davis et al (2014 p30-37) report “Interstitial cystitis/painful bladder syndrome (IC/PBS) is a chronic debilitating condition that can have a severely negative impact on a patient’s quality of life”. Health related quality of life (HRQoL) is a multi-dimensional idea that incorporates a physical, mental, and social aspect about how a person functions socially. It goes past direct measures of populace wellbeing, future, and reasons for death, and concentrates on the effect wellbeing status has on a person’s life. A related idea of HRQoL is prosperity, which surveys the constructive parts of a person’s life , for example, positive feelings and life fulfillment.(Healthy people 2020) describe this condition can  impact on a patients quality of life .As Onwoud (2008)states “The treatment of interstitial cystitis has many uncertainties, including which treatment is the most effective” Interstitial cystitis, sometimes known as bladder pain syndrome (IC/BPS),is where  the lining of the bladder can be inflamed, with symptoms such as bladder pain and urinary frequency sometimes associated with urgency. Patients who repeatedly have sterile urine, and negative urine cultures are usually suspected of having interstitial cystitis .it is inconclusive as to why individuals have IC/BPS, but it is thought to be due to chronic inflammation of the bladder, and possibly from weakness, on the bladder wall. Some evidence may also suggest it can be linked to an autoimmune disorder, in which the body makes substances that attack the lining of the bladder. (Torpe et al 2012) Interstitial cystitis is often associated with other syndromes such as chronic fatigue, irritable bowel syndrome, and fibromyalgia. Chronic stress has been implicated in the development of these particular illnesses (Martinez et al 2014). The symptoms of this condition may vary in different clients, and symptoms over time can change even in the same individual. Patients report mild discomfort, bladder pressure, tenderness in the abdomen or pubic area, or intense pain in the bladder and pelvic area. Symptoms can also include an urgent desire to urinate, frequency, or a combination of both. Pain may change in intensity as the bladder fills with urine or as it empties. During menstruation a female can find that the symptoms intensify making sexual health difficult. Many female patients report pain during vaginal intercourse. Parsons et al (2005) believe that it is more evident in females between the ages of 40 and 60 years. They also found it more dominant in white females with a 9:1 female dominance. Persue et al (167-174, 2010) state “There are still many things to be found out about interstitial cystitis/painful bladder syndrome (IC/PBS) because the pathological processes underlying the condition are not yet elucidated, biological markers of the condition are not yet available, and the type and severity of symptoms can vary, so, clearly defining the condition is not yet possible.” The writer feels it is therefore difficult to ascertain whether the treatment she offers is really successful due to the lack of knowledge or clearly defined causes for this condition and whether treatments are successful. This justifies the rational for specifically focusing on this particular area for research. The writer is aware through nurse led clinics on a weekly basis that this condition is persistent, damaging work life, home life, and psychological well-being, personal relationships and general health. In addition, IC/BPS patients have reported significantly more pain, insomnia and disturbed sleep. In many patients they are depressed, anxious, stressed, and have no social interactions due to the fact they can never leave the house, and the writer often finds that sexual dysfunction is damaging current relationships. So what treatments are available for the patients suffering with this debilitating condition? The writer offers a combination of treatments but due to the constraints of the word limit the writer has decided to research the drug Uracyst. The writer is keen to research the effects of the drug Uracyst to see if the drug improves a patient’s quality of life. The writer carries out an intravesical clinic twice weekly in the outpatients setting receiving direct referrals from the urologists following cystodistention and diagnosis of the condition Interstitial cystitis.15 patients per week are treated for this condition which takes up a large percentage of our client base with a specific diagnosis. This treatment is a costly treatment about £79 per amp so this particular condition is of particular interest to the writer.  Cvach et al (2015) carried out a review of intravesical therapies for the treatment of BPS/IC. “A PubMed search was performed using the terms “bladder pain syndrome”, “interstitial cystitis”, “intravesical”, “instillation” along with the names of the individual agents, with publication dates up to June 2015” Cvach cited work from both Nording et al (2008) and Nickel et al (2009) when looking at his complex condition.Cvach et al (2015) found that BPS/IC was a condition that for some was very challenging both mentally and physically. They identified differences in clinical trials and how patients can react to different treatments .The study stated that it  “Is a condition that requires a multi-disciplinary and multi-modal approach. Having a number of intravesical and oral agents available to each individual patient is important” Cvach (2015) looked at research carried out by Nordling J et al, (2008).Nordling et al (2008) carried out a multi-centre, prospective observational trial 286 patients with chronic cystitis .51 % of these patients had IC/PBS They recorded a baseline observation to the end of the trial and included a baseline score, urgency and pain scores and a global response assessment. The outcome of this trail showed a significant improvement from the base score especially those with IC/ PBS. Nickel et al (2009) carried out a multicentre, community based open-label study designed to look at the safety and effectiveness of the drug in those diagnosed clinically with IC. The results reported that this  “multicentre community based real-life clinical practice study suggests that intravesical chondroitin sulphate may have an important role in the treatment of IC” Nickel et al (p56-60 2009). This does look encouraging but we have to look at the trial with scepticism as both trials have a small client base and the numbers are low. What is Uracyst? 2% solution of sodium chondroitin sulphate.According to Galen pharmaceuticals it is used to replenish the GAG layer of the bladder, for those patients they found that maybe had a damaged GAG layer or when the epithelial layer in the bladder for deficient. It is available in 20ml per vial containing 400mgs of Chondroitin sulpahte) Uracyst is a fluid that is given intravesically in to the bladder. It contains Sterile Sodium Chondroitin Sulphate Solution, 2.0%, and is effective in reducing the symptoms’ of interstitial cystitis/painful bladder syndrome (IC/PBS) .It is by administered intravesically via a catheter under aseptic technique into the bladder and introducing the drug via the catheter. A full consultation is carried out before the treatment commences by both the consultant and specialist nurse and each week before the treatment is given. Barron and White (1996) report that consultation skills are an important aspect in advanced nursing practice. We could argue and say that throughout our working day decision making and problem solving are part of nursing practice, but we need to develop and apply skills that complement advanced practice. As Smith (1995) indicate, by being able to critically analyse and reflect on practice ,this has enabled the nurse to develop new ways of thinking by enhancing self-awareness and promoting development . Health assessment is a way to achieving this. We do not administer to patients with known hypersensitivity to the solution or if infection is present. There are no known adverse effects or reported side effects. Short-term discomfort and irritation may be caused by the catheterisation process. The treatment is omitted if the patient is positive to nitrates on urinalysis or is extremely uncomfortable. Some female patients prefer to omit the treatment during menstruation.Uracyst works by replenishing the bladder with a protective coating of chondroitin sulphate, helping it to become waterproof again. Uracyst is reported to reduce pain, frequency and urgency. The writer wishes to see if this this drug which has been introduced is of benefit to clients, in order for them to be able to function comfortably within their working day. It has not been introduced to cure their condition as evidence based research is very limited. The writer does however want to ascertain if this drug will help their condition and symptoms in order to improve their own quality of life (individual to each patient).IC /PBS patients often have a specific deficit of chondroitin sulphate on the surface of the bladder wall. Intravesical chondroitin sulphate will bind to the bladder wall repairing the damaged bladder epithelium and it coats the surface allowing the GAG layer to replenish. This will then protect the bladder against urine. Question In patients with a diagnosis of interstitial cystitis does receiving Uracyst treatment improve a Patients quality of life? The aim of my study is to assess improvement in patient’s quality of life using a pre and post symptom scores for each patient. Objective To measure the impact of the drug uracyst on a patients quality of life using the O Leary Sant Score tool at Week 1 and week 24. Data was collected through a series of questionnaires at week 1, and week 24. The writer will be using the O’Leary – Sant score. The O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) has been proposed as a treatment outcome measure in interstitial cystitis (IC).As Ludbeck et al (2001) report “The ICSI is a valid, reliable, and responsive measure of change in IC symptoms”.The writer aims to examine the effects of this particular drug and its benefits or side effects. In particular, the writer will focus on how the drug changes a person’s quality of life to such an extent that they can live with their symptoms’ and control them. Such a study should give insights into the symptoms’ that some clients will have and how they differ to other clients. Also, the study will test the usefulness of a perspective (the situational approach) that is underdeveloped in the IC/PBS literature. Kushner et al (2006) looked at the Efficiency of questionnaires used to screen for interstitial cystitis. They found that  “these questionnaires should not be used to define interstitial cystitis, but can be used to screen patients with urinary tract symptoms to identify those who should be further examined for interstitial cystitis or to follow those who have already been diagnosed” (Journal of Urology  2006 176 pg587-92) The O’Leary- sant score will be used to: 1. Discover during the 24 week period whether urgency has improved using the O’Leary- sant score and assessment. 2. Discover over the 24 week period whether frequency has improved using the O’Leary- sant score and assessment. 3. Discover whether nocturia has improved over the 24 week period using the O’Leary- sant score and assessment. 4. Discover whether pain or burning improves over the 24 week period using the O’Leary- sant score and assessment. 5.To assess each person as to whether particular lifestyle changes can result in improvement of symptoms and changes in their life in general using the O’Leary- sant score and assessment. Lifestyle changes such as eliminating certain foods for example oranges, bananas, spicy foods, and Caffeine based drinks can indeed improve a patient’s quality of life. Many of the patients have tried drugs as a first line such as cimetidine, antihistamines, and Amitriptyline. Patients are advised to stay on this medication throughout the course of the Uracyst treatment. From referral to treatment can be a period of around 6 weeks, so on initial consultation the patients usually can report improvement of symptoms from the medications prior to starting intravesical therapy. Research Design This investigation  should use both quantitative and qualitative approach in terms of research as the writer feels  both these approaches are important to meet the aims and objectives of each patient in this investigation and it will answer  the full research question. However the writer wants to gain an insight into improvement scores and the questionnaire approach may be the simplest tool to gain this insight. As Weinreich (2006) reports analysts utilize both quantitative and subjective information to give a more entire photo of the issue being tended to, the intended interest group and the adequacy of the program itself. Subjective strategies utilised as a part of social showcasing incorporate perceptions, top to bottom meetings and center gatherings alongside secondary data such as diaries. These methods are designed to help researchers understand the meanings people accredit to social phenomena and to enlighten the mental processes underlying behaviours. Theories are created amid information gathering and examination, and estimation has a tendency to be subjective. In the subjective worldview, the specialist turns into the instrument of information accumulation, and results may change enormously contingent on who directs the examination. Its focal premise is that the use of quantitative and qualitative approaches in combination provides a better understanding of research problems than either approach alone. For decades, novice scientists were trained to select either quantitative or qualitative, often favoring quantitative. Incompatibility Thesis asserts that “quantitative and qualitative must not be mixed” (Onwuegbuzie & Leech, 2005, p. 376). As Porcino (2010) found mixed method research or techniques is progressively being perceived for its capacity to convey various perspectives to an exploration venture, exploiting the qualities of each of the quantitative and subjective segments to clarify or resolve complex wonders or results. Qualitative research will involve the analysis of data such as words from individual interviews, pictures, or objects and general observations .The qualitative researcher becomes the primary focus for data collection and analysis. Data is mediated through the interviewer and the client, rather than through cache, and questionnaires .It is descriptive in nature and the researcher is interested in process, meaning and understanding gained through the words of the client. Three main types of qualitative data collection will be through, interactive interviewing on a weekly basis, written descriptions and observation. As Myers (2002) reports the ultimate aim of qualitative research is to “offer a perspective of a situation and provide well written research reports that reflect the researchers’ ability to illustrate or describe the corresponding phenomenon.” One of the strengths of qualitative research is the richness and depth of the study. The writer feels however that as there is 3 nurse specialists in the team carrying out the research. This may not be the approach to use as each interviewer may ask different questions. The writer feels that it depends on the interviewer as to the standard of the answers given and they can be misconstrued and not accurate. As three practitioners will carry out the research quantative measures may be more accurate as it will be based on analysing numbers. Research Design.

  • Quantitative research involves analysis of numerical data. The data collected is numeric, allowing for collection of data from a larger sample size. Due to the fact there are 3 nurse specialists the figures generated will allow for greater objectivity when reviewing results and are independent of the researcher.
  • Using the O-Leary Sant score allows the results to be displayed in graphs, charts, and tables examples of these will be found at the end of the essay.
  • It will be less time-consuming and can often be carried out on the computer by anyone of the 3 nurse specialists.
  • Data collection methods can be relatively quick, it will depend on time to input the figures on a weekly basis but again will depend on the type of data being collected.
  • Numerical quantitative data may be viewed as more reliable, as the patient has completed the questionnaire themselves with no input from specialist nurses.

It will be based on a longitudinal study as it will have specific time points week 1 and week 24 .it will focus on improvement of symptoms over a period of 24 weeks .comparisons will be made at the beginning of the treatment and at the end and symptoms scores evaluated. I will be using Random sampling for my project. Random Sampling Random sampling is one of the most well-known of all sampling tools. A random sample is one in which each client has an equal chance of being included in the research   sample. Simple random sample selection may be accomplished in several ways including drawing names or numbers out of a box then picking all odd numbers or even numbers to include the client base. As Mugo Fridah W.states “It can be said that using a sample in research saves mainly on money and time. If a suitable sampling strategy is used, appropriate sample size selected and necessary precautions taken to reduce search will on sampling and measurement errors, then a sample should yield valid and reliable information” The three methods that the writer will look at are

  1. Structured Observation. This method could be used within the outpatients setting for gaining data .Macleod (2015) feels that this type of research has both strengths and weaknesses. He found it could be uses by other researchers and appears reliable. The numerical figures are easier and quicker to obtain results and observations can take place in a short period of time. However the writer feels that it is not viable to see everyone in the outpatients setting following treatment. Time constraints for clinics would not allow for this type of observation to be carried out. Participants may even act differently when being observed therefore questioning the results of the research.
  1. Structured Interview. The aim of this type of methods is to allow all participants the same chance to answer the same questions in the same order. This involves participation with the interviewer. Macleod (2015) again found them easy and quick to conduct. However with no flexibility it will not allow a true picture of the participant. It is not easy to get in depth information from a structured interview or potentially measure a true outcome especially after instillation of a drug.
  1. Structured Questionnaire. This will be the researchers’ method of choice. A pre and post questionnaire will be used to produce a result measured against the instillation of a drug. They are cost effective, manageable and quick and easy to obtain results in the writers’ area of work. They are easy to interpret and gain statistical results through a computer generated programs. The writer feels that the patients will not be under any time constraints to answer the questions and will answer the questions more honestly.

The writer for her research will focus on Quantative research using the The O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI). It has been proposed as a treatment outcome measure in interstitial cystitis (IC).As Ludbeck et al (2001) report “The ICSI is a valid, reliable, and responsive measure of change in IC symptoms”. Participants/Sample. Patients with IC/BPS who have failed first line oral treatments   such as cimetidine Amitriptyline or antihistamines   treatments have been enrolled in this study. They have been on these medications for at least 3 months but the symptoms remained unchanged or relapsed. A diagnosis of IC/BPS has been established based on characteristic symptoms and hydrostatic cystodistention (HD) findings of glomerulation, or mucosal ulceration. Ens et al (2015) conclude that “cystoscopy with HD appears as a necessary and yet irreplaceable diagnostic and therapeutic tool”. Transl Androl Urol. 2015 Dec; 4(6): 624–628. Participants for this research will be patients who have a diagnosis of interstitial cystitis through cystodistention. Participants will be recruited as a random selection from all the patients currently undergoing this treatment. The sample size will be 25% of the total number of patients.  The inclusion criterion simply consists of 1. All patients to be assessed by the consultant prior to commencing treatment. 2. They have consented to the treatment. 3. They have to be prepared to complete the full course. 4. All documentation will be completed by the patient only throughout the course of the treatment. 5. Consultation on each visit will be required and documentation obtained. Both female and male patients may be selected depending on the random sampling process. 6. All patients can read and write. 7. All patients are emotionally y well. Materials. Data will be collected through a series of questionnaires at week 1, and week 24. I will be using the O’Leary – Sant score. The O’Leary- Sant Interstitial Cystitis Symptom Index (ICSI) has been proposed as a treatment outcome measurement tool for the condition. As Ludbeck et al (2001) report “The ICSI is a valid, reliable, and responsive measure of change in IC symptoms”. Consent from the participant will be sought .The first part of the questionnaire will obtain information such as how they are feeling in general. We will have an insight into their present symptoms through a scoring system for urgency Frequency Nocturia Bladder pain and burning. Their condition score will also be assessed before beginning the trial. This will cover the 4 symptoms as previously mentioned. Symptom score is obtained through a six point response format: “not at all, less than 1 times in 5, less than half the time, about half the time, more than half the time and almost always.” The rating score ranges from 0-5. The condition score is obtained through a 5 point response format “no problem, very small problem, small problem, medium problem, big problem. “The rating score ranges from 0-4.This is the quantitative part of the research. The second stage of the data collection will be through assessment each week and recording of data in the patients notes with regards lifestyle. The writer works as part of a team of 3 nurse specialists. Any member of the team can carry out this research with results being returned to the researcher. The clinics take place in secondary care and all data will be obtained in clinic. Questionnaires will be posted out prior to the clinic appointment with extra copies available in clinic if the patients forgets to bring them .The patient will then be given time to complete the documentation. It is a simple easy straightforward tool to use. The use of this data will then be used to assess the response rate. The primary focus will be on the patients’ interaction with staff and also obtaining information as to any improvements in symptoms. Lifestyle advice will be given by all team members. A contact number will be given to each patient to contact any member of the team if any worries arise or if they encounter any problems throughout the treatment. A patient cannot receive the treatment if a urinary tract infection is present. In order for the research to take place they are several key factors before any research can be carried out. The Gate keeper for the research is primarily the consultant. The Consultant will diagnose, and ensure the patient is medically and emotionally fit for treatment. The consultant will prescribe the drug for each patient. Full health assessment will be carried out. Any questions can be directed to the consultant before commencing treatment. Advice leaflets will be given prior to commencing treatment with an opportunity to ask questions on week 1 in the clinic setting. A new appointment slot gives the patient extra time to ask questions or seek further advice. The symptom score can be filled in at this appointment. Before any research can take place it is important to receive informed consent. Royal college of nursing (RCN) in their guidelines cited Parahoo (2006) Informed consent is: “The process of agreeing to take part in a study based on access to all relevant and easily digestible information about what participation means, in particular, in terms of harms and benefits.”(Parahoo, 2006) Informed consent is not just agreeing to take part in research it is about the patient being aware of all the facts before they agree to take part in your research .Ethical and legal codes also play a part in research. All patients should be treated with respect no matter their religion, gender, culture, disability. Researchers must gain approval from the relevant research ethics committee before beginning their research. In Northern Ireland it would be approved from the Office of ethics for Northern Ireland. Limitations:

  • The limitations that the writer may encounter are as follows.
  • Time constraints will be a major factor, as the writer has only 2 outpatients slot per week. This could lead to difficulties and constrained time limits to work on the study due to my demanding clinical role.
  • In my absence for example when on annual leave information may not be analysed correctly.  The major limitation for a patient is if they present with a urinary tract infection. Treatment in this case is omitted and can lead to further outpatients’ appointments. Lifestyle advice following instillation must be adhered to, to prevent this complication. The treatment has to be omitted in this case and antibiotic therapy commenced.
  • Honesty of the participants. they may get someone else to complete the questionnaire
  • All parts of the questionnaire may not be completed leading to incorrect data being recorded.
  • Failures may also occur due to the patient not complying with 1. Medications prescribed by the GP and consultant2. Not adhering to lifestyle advices.3.
  • Nonattendance in the clinical setting.
  • Successful treatment requires full attendance to each weekly slot. Disruption of the cycle by not attending may lead to exacerbation of symptoms and incorrect data being recorded.

Reference List Barron A, White P (1996). Consultation .IN: Hamric A B, Spross J A and Hanson C M (Eds) Advanced Nursing Practice – An Integrative Approach.W B Saunders: Philadelphia. Cvach K , Rosamilia A. (2015 Dec). Review of intravesical therapies for bladder pain syndrome/interstitial cystitis. Transl Androl Urol. 4 (6), 629–637.  Davis, N., Brady, C. and Creagh, T. (2014). Interstitial cystitis/painful bladder syndrome: epidemiology, pathophysiology and evidence-based treatment options. European Journal of Obstetrics & Gynecology and Reproductive Biology, 175, pp.30-37. Ens G, Garrido GL. Role of cystoscopy and hydrodistention in the diagnosis of interstitial cystitis/bladder pain syndrome. Translational Andrology and Urology. 2015;4(6):624-628. doi:10.3978/j.issn.2223-4683.2015.09.04. http://Galen (2011) Uracyst –Chrondroitin Sulfate,2% [Accessed 1 Dec. 2017]. Haq, A., Donaldson, P. and Parry, J. (2001). Oral cimetidine gives effective symptom relief in painful bladder disease: a prospective, randomized, double-blind placebo-controlled trial. BJU International, 88(4), pp.444-445. (2017). Health-Related Quality of Life and Well-Being | Healthy People 2020. [online] Available at: [Accessed 1 Dec. 2017]. Kushner L1Moldwin RM.(2006) Efficiency of questionnaires used to screen for interstitial cystitis. (Journal of Urology  2006 176 pg587-92) Relief in painful bladder disease: a prospective, randomized, double-blind Placebo-controlled trial. BJU Int 2001; 88:444–5. doi:10.1046/j.1464- 410X.2001.02377. Torpy J,  Kasturia MD , Golub RM , (May 23/30, 2012). Interstitial Cystitis. Available: JAMA. 2012; 307(20):2211. doi:10.1001/jama.2012.3943. Last accessed 5th Nov 2015. Lubeck, D., Whitmore, K., Sant, G., Alvarez-Horine, S. and Lai, C. (2001). Psychometric validation of the O’leary-Sant interstitial cystitis symptom index in a clinical trial of pentosan polysulfate sodium. Urology, 57(6), pp.62-66. Martínez-Martínez, L., Mora, T., Vargas, A., Fuentes-Iniestra, M. and Martínez-Lavín, M. (2014). Sympathetic Nervous System Dysfunction in Fibromyalgia, Chronic Fatigue Syndrome, Irritable Bowel Syndrome, and Interstitial Cystitis. JCR: Journal of Clinical Rheumatology, 20(3), pp.146-150. McLeod, S. A. (2015). Observation methods. Retrieved from Moldwin R, (2009) The management of interstitial cystitis or painful bladder syndrome in woman.       BMJ 2009,339. Mugo Fridah W. Sampling in Research (2008)  Sampling in Research. [online] Available at: [Accessed 1 Dec. 20 Myers M, (2000) Qualitive research and the generalisability question: Standing firm with proteus.the qualitative report, 4(3/4) Nickel, J., Egerdie, B., Downey, J., Singh, R., Skehan, A., Carr, L. and Irvine-Bird, K. (2009). A real-life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis. BJU International, 103(1), pp.56-60. Nordling J, van Ophoven A. Intravesical glycosaminoglycan replenishment with chondroitin sulphate in chronic forms of cystitis. A multi-national, multi-centre, prospective observational clinical trial. Arzneimittel-Forschung 2008;58:328-35 O’Leary MPSant GRFowler FJ JrWhitmore KESpolarich-Kroll J. The interstitial cystitis symptom index and problem index Urology. 1997 May; 49(5A Suppl):58-63.Department of Surgery, Harvard Medical School, Boston, MA, USA. Onwude J L (2008) What is the most effective treatment of interstitial cystitis? BMJ 2008; 337 doi: (Published 27 November 2008) Cite this as: BMJ 2008;337:a2325 Parsons M, Toozs-Hobson P. (2005). The investigation and management of. J Br Menopause Soc . 11 (10), 132–9. Persu C, Cauni V, Gutue S, Blaj I, Jinga V, Geavlete P. From interstitial cystitis to chronic pelvic pain. J Med Life. 2010; 3:167–174. Royal college of Nurses (2011) Informed consent in health and social care research RCN guidance for nurses Second edition. Smith C (1995).Learning about yourself helps patient care. Professional Nurse March: 390-392 Van Ophoven A, Pokupic S, Heinecke A, Hertle L. A prospective, randomized, placebo controlled, double-blind study of amitriptyline for the treatment of interstitial cystitis. J Urol 2004; 172:533–6. doi:10.1097/01.ju.0000132388.54703.4d Parahoo K (2006) Nursing research: principles, process and issues (2nd edition), Basingstoke: PalgraveMacmillan. Weinreich N K, (2006) Integrating Quantitative and Qualitative Methods in Social Marketing Research 2006.                                 Clinical Practice Guidelines   2% Chrondroitin Sulfate (Uracyst) for Interstitial Cystitis    

  • Interstitial Cystitis
  • Responsibilities
  • Consultant Urologist
  • Urologist Nurse Specialist
  • Urology Nurse Practitioner
  • OPD  Nursing Staff
  • Administration 2% Chondroitin Sulfate (Uracyst )
  • Patient comfort

 What is Interstitial Cystitis? Interstitial Cystitis (IC) is a chronic bladder inflammatory condition of unknown cause.  At present there is no cure for IC and treatment is aimed at alleviating the symptoms.  Uracyst is known to relieve the symptoms for some people. The luminal surface of the bladder is coated with a layer of glycosaminoglycans (GAGS) that provide a protective impermeable barrier to the bladder. The poly anionic molecules of GAGS bind with water molecules thereby creating a molecular layer of water between the urine and the bladder surface to which the GAGS are bound. This layer inhibits adherence of bacteria, microcrystal’s, carcinogens and ions. Damage to this layer can result in deficiencies to its protective barrier, inducing irritations in the bladder wall. Uracyst can replenish the deficient GAG layer on the bladder epithelium. Indications  For replenishment of the glycosaminoglycan (GAG) layer in the bladder, for patients with damaged or GAG deficient bladder epithelium. The initial course of treatment involves bladder instillations every week for 6 weeks and then one monthly until symptoms are relieved and depending on the symptomatic response. Consultant Urologist  

  • Diagnosis and referral to the  to arrange course of treatment and facilitate any necessary communication.
  • Obtaining informed consent for the administration of Uracyst.
  • Prescribing the course of treatment Uracyst. (2% Chondroitin Sulfate)

Nursing Staff  

  • Liaison with the patient to arrange appointments and provide appropriate information and complete questionnaire prior to first appointment.
  • Arrange appointments .  Appointments are available on Monday am and Tuesday PM.
  • MDT discussion with consultants after 24 weekly instillations.
  • Arrange a follow up outpatient appointment 4 weeks after the last weekly treatment with Urology Nurse Practitioner/Urology Nurse Specialist to update patient questionnaire and first monthly treatment.
  • Notify pharmacy (with script) 7 working days prior to the first treatment
  • The solution is instilled into an empty bladder using a sterile intermittent catheterisation technique.
  • Nursing documentation should be completed and verbal  consent obtained before instillation
  • Prior to the instillation patient should empty bladder and test residual urine for signs of infection.
  • Care must be taken when drawing up and instilling the solution.
  • Apply analgesic lubricant gel such as Instillagel to the urethra prior to insertion of the catheter, to avoid spasm. Please check for allergies to Lignocaine before use.
  • Access to anaphylactic box should be available to treat adverse reaction.
  • Instil the complete 20ml of the solution into an empty bladder, remove the catheter and leave the solution in the bladder for 20 minutes initially. Increase the length of time that the solution is retained in the bladder by ten minutes each instillation. After the appropriate time the solution should be voided into a toilet.
  • Record information on all patients receiving uracyst Bladder Instillation in appropriate book.
  • Record all activity on the TMS system.
  • A letter will go to GP after the first 6 weekly treatments.

Patient Comfort

  • Simple Oral analgesia may be taken prior to administration or following the procedure.
  • Patient should be advised to drink plenty of fluids (2-3litres) for the few days after treatment
  • The medication may cause transient bladder irritability, but usually improves with treatment
  • Please see the Oleary -Sant Score on the next page.

Patient Questionnaire  O-Leary Sant Score To be completed by the patient before Uracyst is instilled at weeks 1, week  and week 24 Patient Name: _____________________________________ Date: _________________________________________ Section A. How have you been feeling overall? 1. Since taking Uracyst at week 0, how would you rate the overall change in your condition?

Week 1   Week 24
Markedly improved N/A
Moderately improved N/A
Slightly improved N/A
No change N/A
Slightly worse N/A
Moderately worse N/A
Markedly worse N/A

Section B. Tell us about your symptoms 1. During the past month, how often have you felt the strong need to urinate with little or no warning?

Week 1   Week 24
0. Not at all
1. Less than 1 time in 5
2. Less than half the time
3. About half the time
4. More than half the time
5. Almost always

2. During the past month, have you had to urinate less than 2 hours after you finished urinating?

Week 1   Week 24
0. Not at all
1. Less than 1 time in 5
2. Less than half the time
3. About half the time
4. More than half the time
5. Almost always

3. During the past month, how often did you most typically get up at night to urinate?

Week 1   Week 24
0. Never
1. Once
2. 2 times
3. 3 times
4. 4 times
5. 5 times
6. 5 times or more

4. During the past month, have you experienced pain or burning in your bladder?

Week 1   Week 24
0. Not at all
1. Once
2. A few times
3. Fairly often
4. Almost always
5. Usually
6. 5 times or more

Section C. Tell us how much your condition has been a problem for you During the past month, how much has each of the following been a problem for you? 1. Frequent urination during the day?

Week 1   Week 24
0. No problem
1. Very small problem
2. Small problem
3. Medium problem
4. Big problem

2. Getting up at night to urinate?

Week 1 Week 10 Week 24
0. No problem
1. Very small problem
2. Small problem
3. Medium problem
4. Big problem

3. Need to urinate with little warning?

Week 1   Week 24
0. No problem
1. Very small problem
2. Small problem
3. Medium problem
4. Big problem

4. Burning, pain, discomfort or pressure in your bladder?

Week 1   Week 24
0. No problem
1. Very small problem
2. Small problem
3. Medium problem
4. Big problem

Section D. Tell us about the pain you have been experiencing 1. Please mark with an X the position on the line below (between the two faces) which best shows how much pain you have been experiencing in the last month? Week 1           No pain         Worst pain ever Week 10           No pain         Worst pain ever Week 24           No pain         Worst pain ever 2. Pain associated with urgency (urgency describes a sudden need to dash to the loo)? Week 1           No pain         Worst pain ever Week 10           No pain         Worst pain ever Week 24           No pain         Worst pain ever .  

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