An interventional study of Therapeutic Wand and Routine physiotherapy control in Painful Bladder Syndrome, sponsored by University of Bradford. Completed. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by University of Bradford · Not applicable, Interventional, and Treatment
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 10 is below the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →University of Bradford is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Routine physiotherapy control
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.
Device: Therapeutic 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.
Also known as: TheraWand
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.
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
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
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
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
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
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
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
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
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.
| Milestone | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Started | 5 | 5 |
| Completed | 4 | 5 |
| Not completed | 1 | 0 |
| Withdrew: Atrophic vaginitis diagnosed | 1 | 0 |
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.
| units on a scale | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Change in ICSI score 0 to 6 weeks | -4.25 ± 0.95 | -6.2 ± 0.83 |
| Change in ICSI score 6 to 12 weeks | 0 ± 0.95 | -1.8 ± 2.12 |
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.
| units on a scale | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Change in ICPI 0 to 6 weeks | -3.5 ± 1.91 | -5 ± 1.41 |
| Change in ICPI 6 to 12 weeks | -0.25 ± 1.29 | -2 ± 0.70 |
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.
| units on a scale | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Change in Genitourinary Pain Index | -10.5 ± 4.04 | -15 ± 6.25 |
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.
| units on a scale | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale | -4.5 ± 2.64 | -9 ± 2.83 |
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.
| units on a scale | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Change in Perceived Urinary Urgency | -30 ± 8.16 | -48 ± 13.03 |
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.
| units on a scale | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Change in Perceived Overall Pain | -25 ± 10 | -46 ± 16.73 |
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.
| units on a scale | Therapeutic Wand Group |
|---|---|
| Perceived Ease of Therapeutic Wand Use | 3.5 ± 0.95 |
Participant reports of adverse events will be recorded to inform development of the method
| Number of adverse events | Usual Physiotherapy Treatment Group | Therapeutic Wand Group |
|---|---|---|
| Subjective Reports of Adverse Events | 0 | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Physiotherapy Treatment Group | — | 0/4 (0%) | 0/4 (0%) |
| Therapeutic Wand Group | — | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Mean | 36.3 ± 17.9 | 32.6 ± 7.2 | 34.4 ± 12.2 |
| Sex: Female, Male(Participants) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| United Kingdom | 4 | 5 | 9 |
| O'Leary-Sant Interstitial Cystitis Symptom Score(units on a scale) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Mean | 10.5 ± 2.64 | 12.4 ± 2.07 | 11.5 ± 2.4 |
| O'Leary-Sant Interstitial Cystitis Problem Score(units on a scale) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Mean | 10 ± 3.9 | 11.2 ± 2.7 | 10.6 ± 3.12 |
| Genito-Urinary Pain Index(units on a scale) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Mean | 27 ± 7.1 | 31 ± 4.9 | 29.2 ± 5.9 |
| The Pelvic Pain and Urinary Frequency Patient Symptom Score(units on a scale) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Mean | 14 ± 3.6 | 16.2 ± 1.6 | 15.2 ± 2.7 |
| Visual Analogue Scale of pain experienced on palpation of the pelvic floor muscles(units on a scale) | Usual Physiotherapy Treatment Group | Therapeutic Wand Group | Total |
|---|---|---|---|
| Mean | 7.25 ± 1.5 | 8 ± 0.7 | 7.6 ± 1.1 |
1 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: No
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University of Bradford