Painful Bladder Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETherapeutic Wand
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.
OTHERRoutine physiotherapy control
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.
Sponsors
University of Bradford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Unblinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18- 65 years - upper limit to reduce the risk of vaginal bleeding upon treatment with the therapeutic wand * A diagnosis of Bladder Pain Syndrome or interstitial cystitis as per the definition of the International Society for the Study of bladder pain syndrome * Symptoms of bladder pain, urgency and frequency in at least the last month prior to study participation * Pain on palpation of the pelvic floor muscles, as per the European Urology Association bladder pain syndrome guidelines * Ability to attend the department for treatment * Ability to give informed consent * Sufficient upper limb control to allow the participant to manipulate the therapeutic wand for self-treatment
Exclusion criteria
* Concurrent diagnoses which may cause pelvic pain including; chronic pelvic inflammatory disease, endometriosis, dysmenorrhoea, or irritable bowel syndrome * Postmenopausal atrophic vaginitis due to risk of vaginal trauma and bleeding with therapeutic wand use * Reasonable suspicion of other treatable pathologies, such as urinary tract infection * No appropriate investigations completed such as urinalysis, urodynamic or cystoscopic assessment during diagnosis of bladder pain syndrome, as per National Institute of Health and Care Excellence (NICE) guidance * Pregnancy or planning to conceive * Symptoms associated only with menses * Undergoing concurrent treatments that could affect outcome e.g. botox or analgesic injections, sacral neuromodulation or physiotherapy treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in O'Leary-Sant Interstitial Cystitis Problem Index Score | Baseline to 6 weeks and 6 to 12 weeks | 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. |
| Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score | Baseline to 6 weeks and 6 to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale | 0 to 12 weeks | 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. |
| Change in Perceived Urinary Urgency | Baseline to 12 weeks | 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. |
| Perceived Ease of Therapeutic Wand Use | 0 to 12 weeks | 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. |
| Change in Perceived Overall Pain | Baseline to 12 weeks | 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. |
| Change in Genitourinary Pain Index | 0 to 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective Reports of Adverse Events | 0 to 12 weeks | Participant reports of adverse events will be recorded to inform development of the method |
Participant flow
Recruitment details
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.
Pre-assignment details
There was no pre-participation period. Once consented to participate participants began the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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. | 5 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Atrophic vaginitis diagnosed | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 17.9 | 32.6 years STANDARD_DEVIATION 7.2 | 34.4 years STANDARD_DEVIATION 12.2 |
| Duration of BPS symptoms | 4.25 Years STANDARD_DEVIATION 4.03 | 5.2 Years STANDARD_DEVIATION 4.02 | 4.8 Years STANDARD_DEVIATION 3.8 |
| Genito-Urinary Pain Index | 27 units on a scale STANDARD_DEVIATION 7.1 | 31 units on a scale STANDARD_DEVIATION 4.9 | 29.2 units on a scale STANDARD_DEVIATION 5.9 |
| O'Leary-Sant Interstitial Cystitis Problem Score | 10 units on a scale STANDARD_DEVIATION 3.9 | 11.2 units on a scale STANDARD_DEVIATION 2.7 | 10.6 units on a scale STANDARD_DEVIATION 3.12 |
| O'Leary-Sant Interstitial Cystitis Symptom Score | 10.5 units on a scale STANDARD_DEVIATION 2.64 | 12.4 units on a scale STANDARD_DEVIATION 2.07 | 11.5 units on a scale STANDARD_DEVIATION 2.4 |
| Region of Enrollment United Kingdom | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| The Pelvic Pain and Urinary Frequency Patient Symptom Score | 14 units on a scale STANDARD_DEVIATION 3.6 | 16.2 units on a scale STANDARD_DEVIATION 1.6 | 15.2 units on a scale STANDARD_DEVIATION 2.7 |
| Visual Analogue Scale of pain experienced on palpation of the pelvic floor muscles | 7.25 units on a scale STANDARD_DEVIATION 1.5 | 8 units on a scale STANDARD_DEVIATION 0.7 | 7.6 units on a scale STANDARD_DEVIATION 1.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
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.
Time frame: Baseline to 6 weeks and 6 to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Physiotherapy Treatment Group | Change in O'Leary-Sant Interstitial Cystitis Problem Index Score | Change in ICPI 0 to 6 weeks | -3.5 units on a scale | Standard Deviation 1.91 |
| Usual Physiotherapy Treatment Group | Change in O'Leary-Sant Interstitial Cystitis Problem Index Score | Change in ICPI 6 to 12 weeks | -0.25 units on a scale | Standard Deviation 1.29 |
| Therapeutic Wand Group | Change in O'Leary-Sant Interstitial Cystitis Problem Index Score | Change in ICPI 0 to 6 weeks | -5 units on a scale | Standard Deviation 1.41 |
| Therapeutic Wand Group | Change in O'Leary-Sant Interstitial Cystitis Problem Index Score | Change in ICPI 6 to 12 weeks | -2 units on a scale | Standard Deviation 0.7 |
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.
Time frame: Baseline to 6 weeks and 6 to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Physiotherapy Treatment Group | Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score | Change in ICSI score 0 to 6 weeks | -4.25 units on a scale | Standard Deviation 0.95 |
| Usual Physiotherapy Treatment Group | Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score | Change in ICSI score 6 to 12 weeks | 0 units on a scale | Standard Deviation 0.95 |
| Therapeutic Wand Group | Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score | Change in ICSI score 0 to 6 weeks | -6.2 units on a scale | Standard Deviation 0.83 |
| Therapeutic Wand Group | Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score | Change in ICSI score 6 to 12 weeks | -1.8 units on a scale | Standard Deviation 2.12 |
Comparison: The control group reported a mean reduction in O'Leary-Sant Insterstitial Cystitis Symptom Score from baseline to 6 weeks that met the MCID (4 points), whereas the TW group reported a reduction of 1.5 times the MCID (ISCI score change: control group 4.25, + 0.95, TW group 6.2, + 0.83). From 6 to 12 weeks the control group reported no change in ISCI score (0 + 0.95) whereas the Therapeutic Wand group ISCI socre reduced by 1.8 +1.73.
Comparison: There was a small mean baseline ICPI score difference of 1.2 points between the groups (control group 10.5, +, TW group 11.2, + 2.68). Both groups reported a reduction in their ICPI scores from baseline to twelve weeks; the control group nearly met the minimal clinically important difference of 4 points and the TW group reported nearly twice the control group's score change (mean change control group 3.75, + 2.44, TW group 7, + 1.87).
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.
Time frame: 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Physiotherapy Treatment Group | Change in Genitourinary Pain Index | -10.5 units on a scale | Standard Deviation 4.04 |
| Therapeutic Wand Group | Change in Genitourinary Pain Index | -15 units on a scale | Standard Deviation 6.25 |
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.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Physiotherapy Treatment Group | Change in Perceived Overall Pain | -25 units on a scale | Standard Deviation 10 |
| Therapeutic Wand Group | Change in Perceived Overall Pain | -46 units on a scale | Standard Deviation 16.73 |
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.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Physiotherapy Treatment Group | Change in Perceived Urinary Urgency | -30 units on a scale | Standard Deviation 8.16 |
| Therapeutic Wand Group | Change in Perceived Urinary Urgency | -48 units on a scale | Standard Deviation 13.03 |
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.
Time frame: 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Physiotherapy Treatment Group | Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale | -4.5 units on a scale | Standard Deviation 2.64 |
| Therapeutic Wand Group | Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale | -9 units on a scale | Standard Deviation 2.83 |
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.
Time frame: 0 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Physiotherapy Treatment Group | Perceived Ease of Therapeutic Wand Use | 3.5 units on a scale | Standard Deviation 0.95 |
Other Pre-specified
Subjective Reports of Adverse Events
Participant reports of adverse events will be recorded to inform development of the method
Time frame: 0 to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Physiotherapy Treatment Group | Subjective Reports of Adverse Events | 0 Number of adverse events |
| Therapeutic Wand Group | Subjective Reports of Adverse Events | 0 Number of adverse events |