Clinical trial NCT02743962: A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome
Official title: A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Painful Bladder Syndrome
Lead sponsor: University of Bradford
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score
timeFrame: Baseline to 6 weeks and 6 to 12 weeks
measure: Change in O'Leary-Sant Interstitial Cystitis Problem Index Score
timeFrame: Baseline to 6 weeks and 6 to 12 weeks
Secondary outcomes:
measure: Change in Genitourinary Pain Index
timeFrame: 0 to 12 weeks
measure: Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale
timeFrame: 0 to 12 weeks
measure: Change in Perceived Urinary Urgency
timeFrame: Baseline to 12 weeks
measure: Change in Perceived Overall Pain
timeFrame: Baseline to 12 weeks
measure: Perceived Ease of Therapeutic Wand Use
timeFrame: 0 to 12 weeks
Other outcomes:
measure: Subjective Reports of Adverse Events
timeFrame: 0 to 12 weeks
Locations:
Study officials:
affiliation: University of Bradford
name: Jilly Bond, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.