Painful Bladder SyndromeNCT02743962
A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome
A study testing Therapeutic Wand in people with Painful Bladder Syndrome, run by University of Bradford.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Painful Bladder Syndrome
- What is being tested?
- Therapeutic Wand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Painful Bladder Syndrome
- Being tested
- Therapeutic Wand, Routine physiotherapy control
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic WandDevice
Also called TheraWand
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.
Routine physiotherapy controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine physiotherapy control |
| 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. Receives: Device: Therapeutic Wand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6 weeks and 6 to 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bradford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jilly Bond, University of Bradford
- Investigators
- Jilly Bond, MSc, Principal investigator, University of Bradford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743962
- Sponsor's protocol ID
- Uni Bradford Protocol 4
- Status last verified
- May 2018
- First submitted
- 4 Apr 2016
- Last updated
- 3 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32734597
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT02743962
- Acronym / sponsor ID
- Uni Bradford Protocol 4
- Conditions
- Painful Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of BradfordUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 3 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual physiotherapy treatment group | Active comparator | Other: Routine physiotherapy controlThis 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 | Device: Therapeutic WandThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic WandAlso: TheraWandThe 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. | Device | Therapeutic Wand group |
| Routine physiotherapy controlThis group will receive standard specialist physiotherapy intervention for bladder pain syndrome as stated in the arm descriptor, and will not use the therapeutic wand. | Other | Usual physiotherapy treatment group |
Primary outcome
Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score
Time frame: 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.
Change in O'Leary-Sant Interstitial Cystitis Problem Index Score
Time frame: 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.
5 secondary outcomes
Change in Genitourinary Pain Index
Time frame: 0 to 12 weeks
Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale
Time frame: 0 to 12 weeks
Change in Perceived Urinary Urgency
Time frame: Baseline to 12 weeks
Change in Perceived Overall Pain
Time frame: Baseline to 12 weeks
Perceived Ease of Therapeutic Wand Use
Time frame: 0 to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32734597Imamura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jilly Bond, MSc principal investigator
University of Bradford
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Wand in people with Painful Bladder Syndrome, run by University of Bradford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score (time frame: Baseline to 6 weeks and 6 to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.