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Bladder pain syndrome is a condition where pain is experienced when the bladder fills with urine and eases briefly when the bladder empties. There can also be a constant need to urgently empty the bladder.
The internal pelvic floor muscles in people with bladder pain syndrome can be tense and painful, and relaxing and stretching them may improve symptoms; reducing bladder pain, urgency and how often people have to empty their bladder.
This pelvic floor release is done by specialist physiotherapists.Therapeutic wands, such as the TheraWand®, are used routinely throughout the United Kingdom to allow people to relax and stretch their pelvic floor themselves. Using a therapeutic wand has been shown to be safe and to reduce pelvic pain, improve bladder and bowel symptoms and relax the pelvic floor muscles. However, this research was conducted mostly in men with pelvic pain.
The aim of this study is to find out if using a therapeutic wand at home as well as having a specialist physiotherapist massage the pelvic floor gives any added benefit than just having the physiotherapy treatment. The investigators hope to find out if the therapeutic wand gives women a way of managing their symptoms independently in their own homes.
A volunteer sample of ten women will be recruited and randomised into two groups, with descriptive analysis of their demographics at baseline. Both groups will receive six weeks of standard pelvic floor myofascial release by a specialist physiotherapist and one group will also use a therapeutic wand twice weekly at home. Outcome measures of bladder urgency, pain, health related quality of life and the perceived effect and ease of therapeutic wand use will be measured weekly for six weeks of treatment and then six weeks following treatment. A diary of therapeutic wand use, release exercises and medication use will also be kept for 3 months. Analysis of any significant difference in symptom change between the two groups and of subjective ease of wand use will then occur and inform the development of a randomised controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual physiotherapy treatment group | Active Comparator | This group will receive standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They will be instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. |
|
| Therapeutic Wand group | Experimental | This group will receive the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, but will also be provided with an intra-vaginal therapeutic wand and taught how to use it. They will then be asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Wand | Device | The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score | Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4 or 5. The total achievable in this outcome measure is a score of between 0 to 19. A higher score describes greater symptoms of Interstitial Cystitis. Total scores were collected for analysis. | Baseline to 6 weeks and 6 to 12 weeks |
| Change in O'Leary-Sant Interstitial Cystitis Problem Index Score | Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4. The total achievable in this outcome measure is a score of between 0 to 16. A higher score describes greater burden of Interstitial Cystitis symptoms on the individual. Total scores were collected for analysis. | Baseline to 6 weeks and 6 to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Genitourinary Pain Index | Single page questionnaire of genital pain and rating of perceived bother. This outcome measure has 9 questions, each has between 4 and 10 potential responses which are weighted differently, between 0 and 10 units. The total achievable in this outcome measure is a score of 45 and the least achievable is a score of 0. A higher score describes a higher perceived genital pain level and greater burden of symptoms on the individual. Total scores were collected for analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Reports of Adverse Events | Participant reports of adverse events will be recorded to inform development of the method | 0 to 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jilly Bond, MSc | University of Bradford | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734597 | Derived | Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2. |
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There was no pre-participation period. Once consented to participate participants began the study.
Urology and Urogynaecology consultants' secretaries identified potential participants using a range of keywords and International Classification of Diseases (ICD-10) codes in April 2016. Potential participants attended a meeting at a single private hospital site and recruitment was completed by the end of May 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Physiotherapy Treatment Group | This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. Routine physiotherapy control: Provision of routine physiotherapy care as control |
| FG001 | Therapeutic Wand Group | This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Physiotherapy Treatment Group | This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score | Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4 or 5. The total achievable in this outcome measure is a score of between 0 to 19. A higher score describes greater symptoms of Interstitial Cystitis. Total scores were collected for analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks and 6 to 12 weeks |
|
Data regarding adverse events were recorded during the 12 week study intervention period, which included 6 weeks of active intervention and a 6 week follow up period.
No adverse events were reported during the study period in either intervention group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Physiotherapy Treatment Group | This group received standard specialist physiotherapy intervention for bladder pain syndrome: dietary advice regarding fluid and fibre intake, advice regarding bladder retraining and 15 minutes manual intra-vaginal pelvic floor muscle myofascial release and gentle stretching each week for 6 weeks. They were instructed to briefly contract and then fully relax their pelvic floor muscles independently (clothed, in a seated or lying position) for 5 minutes daily. This continued for 6 weeks and a 6 week follow up period. Routine physiotherapy control: Provision of routine physiotherapy care as control |
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As a feasibility study a small sample was used, which limits interpretation of the data. A single, unblinded assessor was used and participants were also not blinded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hilary Pape | University of Bradford | 01274 236228 | hpape@bradford.ac.uk |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Unblinded
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|
|
| Routine physiotherapy control | Other | This group will receive standard specialist physiotherapy intervention for bladder pain syndrome as stated in the arm descriptor, and will not use the therapeutic wand. |
|
| 0 to 12 weeks |
| Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale | Single page questionnaire of urinary symptoms, sexual symptoms and perceived bother. This outcome measure has 12 questions, each has between 2 and 4 potential responses which are weighted between 0 and 4 units. The total achievable in this outcome measure is a score of 35 and the least achievable is a score of 0. A higher score describes a worse urinary symptoms, sexual symptoms and a greater burden of the symptoms on the individual. Total scores were collected for analysis at baseline and 12 weeks. | 0 to 12 weeks |
| Change in Perceived Urinary Urgency | This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived urinary urgency. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived urinary urgency. Patients mark along the score line to indicate their perceived urinary urgency. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded. | Baseline to 12 weeks |
| Change in Perceived Overall Pain | This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived overall pain. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived overall pain. Patients mark along the score line to indicate their perceived overall pain. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded. | Baseline to 12 weeks |
| Perceived Ease of Therapeutic Wand Use | This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived ease of using a therapeutic wand. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived ease of therapeutic wand use. Patients mark along the score line to indicate their perceived ease of therapeutic wand use. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded. | 0 to 12 weeks |
| BG001 | Therapeutic Wand Group | This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| O'Leary-Sant Interstitial Cystitis Symptom Score | This outcome measure has 4 questions and scores for each question range from 0 to 4 or 5. The total achievable in this outcome measure is a score of between 0 to 19. A higher score describes worse Interstitial Cystitis symptoms. Total scores were collected for analysis. | Mean | Standard Deviation | units on a scale |
|
| O'Leary-Sant Interstitial Cystitis Problem Score | This outcome measure has 4 questions and scores for each question range from 0 to 4. The total achievable in this outcome measure is a score of between 0 to 16. A higher score describes greater burden of Interstitial Cystitis symptoms on the individual. Total scores were collected for analysis. | Mean | Standard Deviation | units on a scale |
|
| Genito-Urinary Pain Index | This outcome measure has 9 questions and the total achievable in this outcome measure is a score of between 0 to 45. A higher score describes worse genitourinary pain symptoms and a greater impact upon quality of life. Although subscales exist, total scores were used for analysis due to the small sample number of this small feasibility trial. | Mean | Standard Deviation | units on a scale |
|
| The Pelvic Pain and Urinary Frequency Patient Symptom Score | This outcome measure has 11 questions and total scores range from 0 to 31. A higher score describes both worse symptoms and a greater burden on the individual. Although a subscale exists, total scores were collected for analysis due to the small sample size of this small feasibility study. | Mean | Standard Deviation | units on a scale |
|
| Visual Analogue Scale of pain experienced on palpation of the pelvic floor muscles | This is a standard printed visual analogue scale with scores from 0 to 10. Higher scores denote higher pain on palpation of the pelvic floor muscles when tested. | Mean | Standard Deviation | units on a scale |
|
| Duration of BPS symptoms | Mean | Standard Deviation | Years |
|
| OG001 | Therapeutic Wand Group | This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study. |
|
|
|
| Primary | Change in O'Leary-Sant Interstitial Cystitis Problem Index Score | Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4. The total achievable in this outcome measure is a score of between 0 to 16. A higher score describes greater burden of Interstitial Cystitis symptoms on the individual. Total scores were collected for analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks and 6 to 12 weeks |
|
|
|
| Secondary | Change in Genitourinary Pain Index | Single page questionnaire of genital pain and rating of perceived bother. This outcome measure has 9 questions, each has between 4 and 10 potential responses which are weighted differently, between 0 and 10 units. The total achievable in this outcome measure is a score of 45 and the least achievable is a score of 0. A higher score describes a higher perceived genital pain level and greater burden of symptoms on the individual. Total scores were collected for analysis. | Posted | Mean | Standard Deviation | units on a scale | 0 to 12 weeks |
|
|
|
| Secondary | Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale | Single page questionnaire of urinary symptoms, sexual symptoms and perceived bother. This outcome measure has 12 questions, each has between 2 and 4 potential responses which are weighted between 0 and 4 units. The total achievable in this outcome measure is a score of 35 and the least achievable is a score of 0. A higher score describes a worse urinary symptoms, sexual symptoms and a greater burden of the symptoms on the individual. Total scores were collected for analysis at baseline and 12 weeks. | Posted | Mean | Standard Deviation | units on a scale | 0 to 12 weeks |
|
|
|
| Secondary | Change in Perceived Urinary Urgency | This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived urinary urgency. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived urinary urgency. Patients mark along the score line to indicate their perceived urinary urgency. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | Change in Perceived Overall Pain | This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived overall pain. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived overall pain. Patients mark along the score line to indicate their perceived overall pain. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | Perceived Ease of Therapeutic Wand Use | This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived ease of using a therapeutic wand. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived ease of therapeutic wand use. Patients mark along the score line to indicate their perceived ease of therapeutic wand use. The number of millimeters from the 0 point was recorded as their score, for example "57mm". This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded. | Posted | Mean | Standard Deviation | units on a scale | 0 to 12 weeks |
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| Other Pre-specified | Subjective Reports of Adverse Events | Participant reports of adverse events will be recorded to inform development of the method | Posted | Number | Number of adverse events | 0 to 12 weeks |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Therapeutic Wand Group | This group received the standard specialist physiotherapy intervention for bladder pain syndrome for 6 weeks, and were also be provided with an intra-vaginal therapeutic wand and taught how to use it. They were then asked to use the therapeutic wand at home twice a week to release and relax their pelvic floor muscles for 5 minutes. Therapeutic Wand: The therapeutic wand was used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants followed a protocol of sweeping gently along one side then the other to find tender or tight areas, and then applied the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study. | 0 | 5 | 0 | 5 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |