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Assessing patient satisfaction following BTX-A treatment for Overactive Bladder

11666 words (47 pages) Dissertation

9th Dec 2019 Dissertation Reference this

Tags: Medical

Abstract

A service evaluation conducted with a total 173 patients was carried out to assess patient satisfaction following Botulinum Toxin A (BTX-A) treatment for refractory overactive bladder at the Manchester Royal Infirmary. All patients received treatment at the specialised BTX-A outpatient clinic and were asked to complete a questionnaire consisting of 18 questions over the telephone.  The CSQ-8 questions were included to analyse domains of satisfaction and were combined with questions regarding symptoms and quality of life improvement following treatment. At the MRI patients receive 200 U OnabotulinumtoxinA with local anaesthetic and flexible cystoscopy. 100 patients responded and provided complete data. 89 patients were continuing to receive BTX-A treatment. The remaining 11 patients discontinued treatment. The overall mean CSQ-8 satisfaction score was 28.6 representing a very high level of patient satisfaction with the service provided. Results demonstrate a higher satisfaction score amongst patients still receiving BTX-A (mean score 29.7) compared to patients who have discontinued treatment (mean score 25.3) (P < 0.01). The main outcome from the study was the very high satisfaction score overall with a mean value of 9.58 determined using a visual analogue scale. The majority of patients who were no longer receiving BTX-A treatment returned to conservative measures and/or anticholinergic medications for symptom control. Conclusions drawn from this study, using PROMs and PREMs show that patient satisfaction with the specialised BTX-A service offered is very high and results in a positive patient experience by the vast majority. These findings are consistent with published literature.

 

Introduction

Overactive bladder (OAB) is a syndrome predominantly of urinary urgency1, often accompanied by urge incontinence. Many patients also experience symptoms of urinary frequency and nocturia. OAB occurs in the absence of an underlying metabolic or pathological condition.2 The condition, which affects nearly 50 million people in Europe3 has a higher prevalence in females and with an increasing age.4   OAB can be idiopathic or secondary to a neurological cause (e.g Parkinson’s disease, multiple sclerosis, spinal cord injury).4 OAB has been proven to have a significantly affect quality of life due to the impact on physical, psychological and social (especially sexual) aspects of a person’s life. A study that focussed on employment rates reported that due to bladder control problems, 3% had to change job or were fired and over 21% were worried about frequent trips to the toilet and having to interrupt meetings.3 A large economic impact with a total annual cost burden close to €4 billion was determined in a study based on six Western countries.5 Botulinum toxin is now an established as a treatment option for OAB. The current NICE guideline states, “After MDT review, offer bladder wall injection with botulinium toxin A to women with OAB caused by proven detrusor overactivity that has not responded to conservative management.”6 Data was initially limited, but over the last 7 years has been produced from several randomised controlled trials (RCTs) which have been published. Conclusions from these trials prove that treatment is well tolerated by patients. Improvements in the number of episodes of frequency, urgency and urinary incontinence were significant in patients who were not receiving adequate symptom relief from anticholinergics.7,8

Patient reported outcome measures (PROMs) using disease-specific quality of life outcomes and general health related quality of life (HRQOL) outcomes have been proven statistically significant.9 Generally, patients with mild symptoms of overactive bladder are initially treated in a primary care setting with conservative measures consisting of lifestyle changes such as encouraging a caffeine intake reduction, moderating fluid intake and a medication review especially in the elderly. Physiotherapy such as pelvic floor exercises and bladder drill are also used if symptoms are considered manageable. 10

Following this, one of a range of the available anticholinergic medications and β3-agonist medications are introduced. Advancement in the study of refractory OAB has led to the inclusion of invasive management options including botulinum toxin type A (BTX-A) or percutaneous sacral nerve stimulation in the current NICE algorithm for treatment.6

Since the introduction of bladder wall injections of BTX-A, which works by reducing muscle contractibility at the injection site, there has been a significant development in the management of overactive bladder syndrome. The neurotoxin complex works by blocking neurotransmitters from presynaptic nerve endings10. A cystoscope is used to deliver injections at 20-30 sites across the bladder usually sparing the trigone. BTX-A can be administered under local or general anaesthesia and techniques of both rigid and flexible cystoscopy can be used. Flexible cystoscopy and local anaesthesia are the preferred methods due to being quick, easy and carrying fewer risks as described in a report which justifies this method as least invasive technique for treatment11.

At the Manchester Royal Infirmary, the outpatient department consists of a specialised nursing team and medical staff delivering BTX-A with local anaesthesia and flexible cystoscopy.

Evaluating patient experiences of services in healthcare is a priority for service improvement initiatives and health policies. The use of patient reported outcome measures (PROMs) has expanded in the NHS over the last 10 years leading to the collection of PROMs by all NHS-funded providers since April 2009. Patient Reported Outcome Measures (PROMs) assess the effectiveness of care delivered to NHS patients from the patient’s perspective. PROMs calculate the health gains after surgical treatment using pre and post-operative surveys.12

These tools aim to determine the patient’s views of their symptoms (specifically whether there has been symptom reduction) and the effect of these symptoms on their quality of life. Combined with clinical outcomes, this provides the best measure of the overall effectiveness of a treatment. It is also valuable for development of service improvement to assess patient’s views on the care they receive and their experience within the health service. PREMs (Patient-reported experience measures) are therefore essential in addition to PROMs so that the patient’s views are fully captured in relation to the safety of treatment they receive and views on experience of care.13 Evaluating treatment using both PROMs and PREMs is thought to be the most comprehensive and complete method to determine the overall satisfaction of a treatment.

Aims:

  • This primary aim of this study is to evaluate patient-reported satisfaction with BTX-A treatment and to assess patient experiences of the specialist service provided at the Manchester Royal Infirmary Hospital.
  • To determine how many patients discontinued treatment and to reasons for doing so.
  • To determine whether those who were unsuccessful with treatment with BTX-A were less satisfied with the service provided.  
  • To establish whether the number of BTX- A treatments administered affects patient satisfaction with treatment.

 

Method

 

I designed the questionnaire with inclusion of the 8 domains in the CSQ- 89 questionnaire bearing in mind the retrospective study. A list of patients treated with BTX-A at Manchester Royal Infirmary was generated using the Chamaeleon electronic medical record system and this provided a list of 173 ID codes which I used to access telephone numbers and patient details to conduct the interviews. I chose to interview the patients over the telephone to obtain immediate results and because I expected this method to yield more responses than a postal method. All interviews were conducted with a consistent method and patients were asked to complete the same questionnaire (figure 1.1 and 1.2) over the telephone whilst I filled in the questionnaire. I was working independently to the team providing the BTX-A service which reduces bias towards results. As this is a service evaluation study, formal ethical approval was not required.

The questionnaire design was produced based on the CSQ-8 questionnaire which is a tool that was designed to easily generate an estimation of client satisfaction with a health service. It is a unidimensional test has been heavily tested in diverse populations in several studies.14

These questions were combined with specific questions regarding symptom improvement and subsequent deterioration. I also decided to explore reasons for discontinuation and if relevant subsequent treatment options sought out by those who failed with BTX-A treatment. As I also wanted to focus on social aspects of the patient’s satisfaction in relation to treatment, the questionnaire included two questions based on effect of overactive bladder on their partner and whether there was quality of life improvement following treatment. Initially I had designed separate questionnaires; one for the patient and one for the partner, so that response from the partner was from their own perspective (not their partner’s). This original idea would have been more suited to a postal questionnaire rather than over the telephone however I realised this would be too time consuming and would yield less overall results Therefore I decided to add in questions 17 and 18 (figure 1.2) to gain an insight into patient’s perspective on the effects of their partner following treatment at the MRI.

In total I managed to complete 100 questionnaires over the telephone.

Manchester Royal Infirmary Patient Satisfaction Questionnaire- Botox for OAB

  1. How many Botox treatments have you had?

1                         2                      3                         4                        5                    >5

 

  1. In which order did these urinary symptoms affect you the most before the treatment? Please rank (1= most affected 5=least affected)

Urging to go    Going more often    Waking up at night to go      Leaking before you get to the toilet

  1. Regarding the symptoms what are your main concerns? Please rank (1= most concerning 4=least concerning)

Diabetes                UTI’s               Bladder Cancer                  Prostate Cancer                Other

  1. Followingtreatment, how soon after did you notice the symptoms start to improve?

      <1 week        1-2 weeks     2 weeks-1 month       1-3 months    3-6 months      >6 months

 

  1. Following the treatment, when did you experience the maximum benefit?

0-3 months        3-6 months        6-9 months         9-12 months        >12 months

  1. When you were experiencing maximal benefits, how would you compare the symptoms at that point compared to before the treatment?

    Very much better

    Very much worse

Much better

A little better

No change

A little worse

Much worse

  1. How long after the treatment did you notice the symptoms start to deteriorate?

0-3 months        3-6 months        6-9 months         9-12 months        >12 months

  1. When you noticed the point of deterioration, did you start taking medications?

    Yes                   No

  1. How long after treatment did it take for your symptoms to return to how they were before treatment?

0-3 months        3-6 months        6-9 months         9-12 months        >12 months

Figure 1.1

  1. Following the treatment did you experience any of the following complications?
  • UTI’s

None                   1                     2                    3                       4                      >4

  • Self Catheterisation

Yes: temporarily        Yes: continuous                No

  1. Overall how did the treatment compare to your expectations?

    Almost all of my needs were met

    Most of my needs were met

    Only a few of my needs have been met

    None of my needs have been met

  1. How would you rate your overall satisfaction with the treatment at the MRI? (rate from 1 to 10. 1=least satisfied, 10= most satisfied)

 

  1. Would you consider having the treatment again?

Definitely not             Unlikely                    Unsure                Likely                 Definitely

  1. Would you recommend this treatment to a friend?

Definitely not             Unlikely                    Unsure                Likely                 Definitely

  1. Do you think the condition had an adverse effect on your partner’s quality of life?

         Yes                 No

 

  1. Do you think the treatment improved your partner’s quality of life?

 Yes             No

 

  1. If you are not currently having Botox treatment, which treatment are you using?

Medication                 SNS              PTNS              Surgery                     Other             Nothing

  1. If you have discontinued the treatment, what was the reason for doing so?

Poor efficacy        Side effects            Distance             Improvement

Figure 1.2

Results

A list of 173 patients was generated using Chameleon software with a search criteria to include patients who underwent bladder wall injections of BTX-A at the Manchester Royal Infirmary. The entire list was contacted for interview and complete data was obtained for 100 patients. These responses have been analysed in this report. The median age was 57 years with a range of 29–82 years. 57% of patients contacted were females. The modal number of injections administered to patients was 3 with a mean of 3.4.

CSQ-8 Scores

The CSQ-8 questions can be analysed in isolation to make comparisons within each of the 8 domains. The final score ranges from 8 to 32, with higher scores indicating greater degrees of satisfaction14. The CSQ-8 results show that the overall mean satisfaction score was 28.6 with a standard deviation of 3.25, representing a high level of satisfaction within these domains at Manchester Royal Infirmary received by the patients.  Of the 100 patients, 11 had discontinued their treatment with BTX-A injections. A lower mean satisfaction score of 25.3 and a standard deviation of 4.8 (p<0.001) was calculated indicating that those who discontinued treatment were less satisfied compared to patients still receiving treatment.

The same relationship is evident in the breakdown of the 8 domains, especially domain 3 when patients were asked about whether their needs were met. The graph below shows comparatively a higher mean score in domains relating to quality of service, recommendation and satisfaction (domains one, four and five), compared to domains three and six, which relate more closely to efficacy of the treatment for the group of patients that discontinued treatment. (Figure 2)

CSQ Domains comparison

Figure 2

92% of patients (72% definitely and 20% likely) said they would return for treatment in the future and 99% (85% definitely, 14% likely) said they would recommend the treatment to a friend. This is irrespective of whether they had discontinued their BTX-A treatment or not. Most patients regarded the service at the MRI as excellent (67%) with 29% rating it as good, with 3% stating it was fair and 1% poor.

Regarding overall satisfaction rating, when asked to rate their overall satisfaction from 1-10 (10 being highest level of satisfaction), 65% responded as “10”, 29% with “9”, 5% with “8” and 1% with “7”. These figures demonstrate a very high level of satisfaction. When comparing the means of these scores for the group of patients who are still having BTX-A compared to those who are not, the means (9.65 and 8.3 respectively) demonstrate a high overall satisfaction in both groups with a higher mean for those continuing with BTX-A.

Regarding the patients no longer using BTX-A, 4 have reverted to using medications, 1 patient is using Percutaneous Tibial Nerve Stimulation, 1 patient is using Sacral Nerve Stimulation, and 5 patients are not using any treatment.

Poor efficacy was the main reason for discontinuation (6 patients) with 4 patients reporting symptom improvement to the level that they don’t require further treatment. 1 patient reported travelling distance for treatment as the reason for discontinuation. (Full results in appendix)

Analysis of symptoms

Patients were asked to rank their symptoms in order of severity prior to treatment. 75% patients reported urgency as their most predominant symptom followed by frequency (22%). Nocturia and incontinence were also reported but were ranked as less predominant than urgency and frequency. Mean ranks (1=most severe) Urgency=1.3 Frequency = 1.95, Nocturia= 3.6, Incontinence=3.2. No other symptoms were asked about.

When asked about the main concerns regarding these symptoms, 26% reported concerns of urinary tract infection and 14% reported concerns of cancer (bladder or prostate).

Questions 4-9 of the questionnaire revolved on the relationship between the time treatment was administered and symptom improvement and deterioration. When conducting the interviews, I asked the patients to answer the relevant questions based on their most recent injection.

Most patients noticed a quick improvement following treatment with 72% reporting symptom improvement within 1 week and a further 25% noticing symptom improvement between 1 and 2 weeks.  Similarly the maximum point of benefit received was soon after treatment with 72% stating that it was in the first 3 months and 26% of patients received maximum benefit between 3 and 6 months following their most recent treatment. (Figure 3)

 Figure 3

Following the treatment, when did you experience a maximum benefit?

Following the treatment, how soon did symptoms start to improve?

 

Symptom improvement was significant for most demonstrated when asked how much better symptoms were at maximum point of benefit compared to before treatment. 96% noticed some level of improvement with most (47%) reporting their symptoms as “very much better”. 36% reported symptom improvement as “much better” and 13% reported “little better”.

Responses regarding the time before deterioration of symptoms following treatment were more varied. The modal group said that it was between 9 and 12 months (38%). The range of answers received was from 3 months to over 12 months. At the point of deterioration, 25% of patients said that they started to use medication for symptom control. When reporting on how long it took before symptom levels were back to the same as before treatment, again the modal group was 9-12 months (higher percentage 40%) and 14% reported >12 months which is a higher than the percentage (10%) reported in the question regarding the point of symptom deterioration (question 7). (Figure 4)

How long after treatment did it take for symptoms to return to how they were before treatment?

How long after treatment initiated did you notice the symptoms start to deteriorate?

Figure 4

Following treatment, the main complication reported was urinary tract infections, with 40% reporting at least one. 16% had one infection and only 2% had more than 4 infections following treatment. 24% of patients reported some level of self-catheterisation (16% reported that this was temporary and 8% reported as on-going).

In the final part of the questionnaire, patients were asked whether they believed that their condition affected their partner’s quality of life. 66% answered “yes” to feeling like their partner had been affected. 64% of patients reported that they felt the treatment has improved their partner’s quality of life in some way. (Note: in the 34% of patients that said the partner was not affected, 60% of these patients reported “no comment” due to not having a partner”. Similar results for quality of life improvement following treatment in the next question- questions 17 and 18). These results quantify the large impact the condition has on patients’ relationships and shows that the majority of patients’ partners received a degree of quality of life improvement due to the BTX-A treatment.

Comparison of patients who had 1 treatment vs patients who had more than 1 treatment

10 patients studied had 1 treatment and 90 patients had 2 or more Botox treatments. There was no noticeable difference between the time it took symptoms to improve or when the patients received maximal benefit between the two groups.

However there was a difference in response between the two groups when asked to compare improvement of symptoms before and after treatment. In the group that only had 1 treatment, 20% of patients experienced no change however only 2.2% of patients reported no change in the group of patients that had at least 2 treatments. Similarly, in the group that had 1 treatment 20% reported little change and in other group, a lower percentage of 12% was recorded. These results indicate that patients who received one treatment had less improvement in symptoms than the patients who received at least two treatments.

Another difference is that the modal group selected for point of deterioration for the group with 1 treatment was at 3-6 months. By comparison the group with at least two treatments had a modal group that was a longer period of time at 9-12 months. None of the patients who had 1 treatment reported symptom relief greater than 12 months however 15% of patients in the second group expressed more than 12 months of symptom improvement.

Satisfaction was high for both groups were high for both groups; however the group with at least 2 treatments had a higher mean satisfaction score (9.6 and 8.8 respectively). Scoring a 10 was the outcome for 30% of patients who had 1 treatment however it was 69% for the patients who had 2 or more treatments indicating a greater degree of satisfaction in that group.

Regarding having the treatment again in the future, the most noticeable difference was that a smaller percentage of patients with only 1 treatment said that they would ‘definitely’ have the treatment again (30% compared to 77%). Overall, of the patients with 1 treatment, 60% said that they would more likely than not have the treatment again. By comparison, a higher percentage of 95.5% of patients with 2 or more treatments said that they would likely have the treatment again indicating a higher percentage of treatment success resulting in future treatment in this group. However regarding recommendations to friends there was not much difference between the groups, with overall 99% saying that they would recommend the treatment. When speaking to patients about this over the telephone, the patients that did not receive sufficient benefits from the treatment themselves described how they were aware of the high success rate which would provide a basis for their recommendation. (see appendix section 3 for breakdown of results).

As there were only 10 patients who had only 1 treatment, further data collection with more patients who have only had 1 treatment would be useful in order to validate conclusions made regarding the comparison of the two groups.

Discussion

As stated in the aims and introduction of the report, evaluating PROMs (Patient Reported

Outcome Measures), effects on health-related quality of life, and patient satisfaction with

treatment are all essential for service improvement, and to assure quality of a treatment.  The NHS

has published Outcome Framework indicators  (NHS OF) in order to encourage transparency,

quality improvement and the measurement of outcomes throughout the NHS. Within the five

domains stated there is an emphasis on generating positive experience of care for patients through

quantifying satisfaction, enhancing quality of life for long term conditions such as OAB and

improving safety measures which will lead to health improvement.15

The use of Patient Reported Experience Measures (PREMs) to measure patients’ experience for a

given treatment have been separately developed, but it is now established within healthcare that

combination of PROMs, PREMs and clinical outcomes provide the best measure to determine

overall effectiveness . Due to the chronic benign nature of overactive bladder adequate patient

reporting is essential to assess the impact and effectiveness of treatment.

When researching literature in respect to BTX-A as a treatment for OAB, I came across many studies

of varying  sample sizes and demographics based on the clinical effectiveness and patient-reported

satisfaction .16,17  However I found little published literature in which PROMs and validated PREMs

were used to assess overall experience and satisfaction with bladder wall injections of BTX-A

treatment as well as assessing the service provided.18

The outcome which was the primary aim from the study I conducted demonstrated an extremely high satisfaction with BTX-A treatment, with an overall mean patient satisfaction score of 9.58 (using a visual analogue scale out of 10). 92% of patients continuing to receive treatment reported that they would ‘likely’ or ‘definitely’ have the treatment again (questions 12 and 13 respectively).

In a study on patients’ perspective of BTX-A as a long term treatment option for neurogenic detrusor overactivity as a results of spinal cord injury, the study of 72 patients also interviewed by telephone concluded that 90% would consider BTX-A as a long term treatment. The same Visual analogue scale was included in the survey and a result of 6.2 was obtained which is much lower than the result in this study.16

Another study comparing satisfaction pre- and post-BTX-A injections compared satisfaction of 30 patients with neurogenic detrusor over activity and idiopathic detrusor over activity before and after treatment with BTX-A who were previously using anticholinergics. The results show that over 83% were “satisfied” or “very satisfied” following treatment compared to the majority being “dissatisfied” or “very dissatisfied” prior to the treatment when they were using of anticholinergics. These were results were according to their self-designed 5-point scale created for the study.17 These results show a similar effectiveness from BTX-A treatment to satisfaction feedback received in this study.

44 patients refractory to anticholinergic treatment with OAB symptoms were injected with 200U BTX-A and were then asked to complete a bladder diary, were examined and were interviewed with 27 questions to determine effectiveness of treatment. Results showed an overall mean satisfaction score of 6.6 on a visual analogue scale at 3 month follow-up. The satisfaction results I obtained in this study were higher than the scores produced from these studies but consistent with the general positive satisfaction score and conclusion that BTX-A is an effective treatment for symptom control.19

More recently, a double- blind phase 3 randomised placebo- controlled trial which consisted of 554 patients reported that 62.8% of patients perceived their condition to have greatly improved or improved 2 weeks after treatment vs 27% in the placebo group.1 The results showed reduction in all OAB symptoms for the treatment group compared to the placebo group with a significant reduction especially urinary incontinence (-2.95 p<0.001)  The results from this study correlate with the results I obtained regarding symptom benefit where 72% received symptom relief within the first week.

Similarly, conclusions drawn from another phase 3 study (based on 600 patients) demonstrated a significant improvement in health-related quality of life. Again, all symptoms of OAB were reduced and there was significant reduction (60.8%) in the treatment group which was over double the values in the control group. At maximum benefit symptoms 23% were completely continent and there was significant improvement, similar to high figures in this study (appendix question 6). 8

Pain experienced with botulinum toxin injections under local anaesthesia with flexible cystoscopy have been studied using a visual analogue scale based on pain scores.20 Popat et al. and reported low mean pain scores of 3.3 in a study of 31 patients with idiopathic detrusor activity. In this report, the conclusion was that the majority of patients would be willing to undergo repeat injections despite varying levels of discomfort.21 Another questionnaire based study by Ballert and Nitti also reported low pain and anxiety scores using the same cystoscope technique.22 It is becoming increasing rare for injections to be performed under general anaesthesia with the technique at the Manchester Royal Infirmary (local anaesthesia and flexible cystoscopy) most commonly used.

The data obtained from this study shows that patient experience with the BTX-A service, using a dedicated outpatient-based injection clinic and open-access to specialist medical and nursing staff, is very high with high satisfaction scores in all components of the CSQ-8 questionnaire.

Almost all patients (96%) regardless of efficacy, rated the quality of the service as ‘good’ or ‘excellent’, with most willing to use the service again and to recommend the service to a friend. As shown in the appendix and results, the service met the expectations of the majority of patients, with most feeling able to deal with social problems more effectively as a result. This was in particular regarding the quality of life improvement of their partner following treatment. 64% reported that their partner was experiencing a better quality of life following treatment.  I am unable to compare these figures to previous studies as I was unable to find data which collected quality of life improvement specific to the partner.

It was expected that those who had discontinued treatment with BTX-A would have a lower satisfaction score as I presumed they were not satisfied with the outcome and therefore would give a significantly lower figure on the visual analogue scale. Although a lower value is seen in the results, the satisfaction score was still very high and did not represent a statistically significant decline in satisfaction. Overall, patients who discontinued treatment because of a lack of efficacy or complications still rated the quality of the service highly, despite reporting lower scores for those domains of the CSQ-8 that relate to efficacy or improvement in the condition. This demonstrates the importance of measuring this aspect of healthcare provision separately from clinical outcomes when evaluating the overall benefit of a service.

The reasons for discontinuing BTX-A treatment have previously been investigated in a small number of studies. In one study where 100 patients received at least 1 injection with BTX-A symptoms and discontinuation of BTX-A were investigated. Rates of discontinuation after the first and second injections were 25% and 22%, respectively, but negligible thereafter. The most common reason for discontinuation was lack of efficacy (13%), while others discontinued because of dissatisfaction with CISC, or pain out of proportion with relief. 23

A larger study of 268 patients took place over 7 years.There was a surprisingly high discontinuation rate of 63.8% at 60 months. This was mostly due to high reports of UTIs or need for CISC which were very much higher than the figures in this study. Of those that discontinued treatment, the majority returned to conservative treatment  or anticholinergics for control of their symptoms, 21.7% proceeded to have sacral neuromodulation and 13.4% proceeded to have major surgery (e.g augmentation cystoplasty).24

There are important limitations to recognise from these studies in particular the latter study where prophylactic antibiotics were not used and of higher doses of BTX-A than those currently recommended were administered. I think these factors must be taken into consideration when noting the higher discontinuation than the rates reported in this study at the Manchester Royal Infirmary.

In the study I have undertaken, results show that the most common reason for discontinuation (10 patients) was lack of efficacy in 60%, with 10% stopping because of complications UTI or need for CISC), and with a small number of 4 patients reporting no recurrence of their overactive bladder symptoms. I found these results to be similar to published literature.25

From the data collected, the majority of patients who had discontinued BTX-A treatment (83%) returned to no further treatment, conservative management or anticholinergics. A minority of patients went on to have sacral neuromodulation or percutaneous posterior nerve stimulation.

I was unsuccessful in finding any published literature evaluating why patients who have previously failed anticholinergic treatment subsequently find this treatment acceptable and effective after the BTX-A injections. Similar findings in the United Kingdom however, have been reported.24

Limitations

Due to the retrospective nature of this study, limitations include recall bias in data collection. This is particularly relevant when determining satisfaction from successful treatment within a service provided. For some of the data collected there was a significant time period between treatment and evaluation which could have affected the consistency in recollection of data.

However, the aim of the study was to conduct a service evaluation and the only way to determine outcomes following treatment is to analyse data after a service has been established for a period of time.

It was impossible to achieve a complete response rate in this study and therefore I was unable to capture the outcomes of the entire cohort (58% of patients results were obtained). This also could introduce a potential addition of bias in the results analysed.

The method deemed most suitable to yield results were questionnaires completed by telephone interview. This was decided following consideration of face-to-face interviews or postal questionnaires as alternative methods. The method used could have affected the results obtained.  However, despite these limitations, this is the study managed to meet the aims set out to use a validated patient reported experience measure to demonstrate the high levels of patient satisfaction with a BTX-A service centred on an outpatient-based injection clinic at the Manchester Royal Infirmary.

 

Conclusion

In conclusion, the satisfaction study carried out successfully combined a validated PREM with a PROM to assess patient satisfaction with both the service and treatment of BTX-A for refractory overactive bladder. From the results I determined that in the setting of a dedicated specialist clinic overall patient experience and satisfaction with the BTX-A service is high at the Manchester Royal Infirmary. This was the primary aim of the satisfaction survey. The high patient-reported satisfaction rates with BTX-A treatment were consistent with published literature. The use of a dedicated service, with the increased attention the patient receives from specialist nursing and medical staff can influence the patient experience and satisfaction. A small proportion of patients discontinued treatment with BTX-A and I found it surprising that a large proportion of these patients recommenced conservative strategies or anticholinergic medications and found this effective. Further studies in this area could be the next step for development and research regarding maximising treatment satisfaction for patients with overactive bladder.

Another area for further research where data is lacking is how the treatment has affected the partner’s quality of life and the degree of improvement. An assessment independent to the patient could be created in order to evaluate this in detail.

The main limitations of the study were its data collection regarding the retrospective nature and element of recall bias.

Appendix

Values are given as percentages (%)

Section 1

1) How many Botox treatments have you had?
1 10
2 20
3 40
4 8
5 12
>5 10
2) Rank which symptoms affected you the most before treatment? (1= most affected)
Urgency Frequency Nocturia Leaking before getting to toilet
1 75 22 0 3
2 25 52 6 17
3 3 20 39 38
4 0 3 55 42
3) Regarding the symptoms what are your main concerns?
UTI 26
Cancer(Bladder/Prostate) 14
None 60
4) Following the treatment, how soon did symptoms start to improve?
<1 week 72
1-2 weeks 25
2 weeks- 1 month 2
1-3 months 1
3-6 months 0
>6 months 0
5) Following symptoms when did you have maximum benefit?
0-3 months 72
3-6 months 26
6-9 months 2
9-12 months 0
> 12 months 0
6) At maximum benefit how would you compare the control of symptoms to before the treatment?
Very much better 47
Much better 36
Little better 13
No change 4
Little worse 0
Much worse 0
Very much worse 0
7) How long after treatment initiated did you notice the symptoms start to deteriorate?
0-3 months 5
3-6 months 17
6-9 months 30
9-12 months 38
>12 months 10
8) When you noticed the point of deterioration did you notice the symptoms start taking medications?
Yes 25
No 75
9) How long after treatment did it take for symptoms to return to how they were before treatment?
0-3 months 4
3-6 months 15
6-9 months 27
9-12 months 40
>12 months 14
10) Following treatment did you experience any complications?
UTI
0 60
1 16
2 11
3 7
4 4
>4 2
Self catheterisation
No 76
Yes: Temp 16
Yes: still 8
11) Overall how did treatment compare to expectations?
Almost all needs met 88
Most needs met 8
Only a few of needs met 2
None of needs met 2
12) Overall satisfaction rating with the treatment at MRI? (10 = most satisfied)
10 65 Excellent 67
9 29 Good 29
8 5 Fair 3
7 1 Poor 1
13) Would you consider having treatment again?
Definitely not 0
Unlikley 2
Unsure 6
Likley 20
Definitley 72
14) Would you recommend this treatment to a friend?
Definitely not 0
Unlikely 0
Unsure 1
Likely 14
Definitely 85
15) Do you think this condition adversely affected you partner’s quality of life?
Yes 66
No 34
16) Do you think this treatment improved your partner’s quality of life?
Yes 64
No 36
17) If not having Botox, which treatment are you currently using?
medication 4
SNS 1
PTNS 1
Surgery 0
other 0
None 5
18) If discontinued, why?
Poor efficacy 6
Side effect 0
Distance 1
Improvement 4
Section 2
CSQ-8 mean domain scores
No longer having BTX-A Still having BTX=A
1)Quality of service 3.4 3.7
2)Wants 3.3 3.8
3)Needs 2.5 3.85
4)Recommends 3.5 3.85
5)Satisfaction 3.5 3.8
6)Helped 3.3 3.9
7)Overall satisfaction 3.4 3.75
8)Return 3.4 3.9
CSQ-8 score mean= 25.3 mean= 29.7
S.D= 4.8 S.D= 3.1
Overall CSQ-8 score mean=28.6
SD=3.25
Section 3
Comparison of patients who received 1 treatment vs > 1 treatment
1 treatment >1 treatment
No. of patients 10 90
4) Following the treatment, how soon did symptoms start to improve?
<1 week 8 64
1-2 weeks 2 23
2 weeks- 1 month 0 2
1-3 months 0 1
3-6 months 0 0
>6 months 0 0
5) Following symptoms when did you have maximum benefit?
0-3 months 7 65
3-6 months 2 24
6-9 months 1 1
9-12 months 0 0
> 12 months 0 0
6) At maximum benefit how would you compare the control of symptoms to before the treatment?
Very much better 4 43
Much better 2 34
Little better 2 11
No change 2 2
Little worse 0 0
Much worse 0 0
Very much worse 0 0
7) How long after treatment initiated did you notice the symptoms start to deteriorate?
0-3 months 2 3
3-6 months 5 12
6-9 months 2 28
9-12 months 1 37
>12 months 0 10
8) When you noticed the point of deterioration did you notice the symptoms start taking medications?
Yes 3 22
No 7 68
9) How long after treatment did it take for symptoms to return to how they were before treatment?
0-3 months 2 2
3-6 months 5 10
6-9 months 2 25
9-12 months 1 39
>12 months 0 14
12) Overall satisfaction rating with the treatment at MRI? (10 = most satisfied)
10 3 62
9 3 26
8 3 2
7 1 0
Excellent 5 62
Good 3 26
Fair 1 2
Poor 1 0
13) Would you consider having treatment again?
Definitely not 0 0
Unlikley 1 1
Unsure 3 3
Likley 3 17
Definitley 3 69
14) Would you recommend this treatment to a friend?
Definitely not 0 0
Unlikely 0 0
Unsure 0 1
Likely 3 11
Definitely 7 78
15) Do you think this condition adversely affected you partner’s quality of life?
Yes 5 61
No 5 29
16) Do you think this treatment improved your partner’s quality of life?
Yes 4 60
No 6 30
17) If not having botox, which treatment are you currently using?
medication 2 2
SNS 0 1
PTNS 0 1
Surgery 0 0
other 0 0
None 2 3
18) If discontinued, why?
Poor efficacy 2 4
Side effect 0 0
Distance 0 1
Improvement 2 2

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