N/A
N=10
A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome
Painful Bladder Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02743962 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score — -4.25; -6.2; 0; -1.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Therapeutic Wand (Device); Routine physiotherapy control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Bradford
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score |
-4.25; -6.2; 0; -1.8 | — |
| PRIMARY Change in O'Leary-Sant Interstitial Cystitis Problem Index Score |
-3.5; -5; -0.25; -2 | — |
| SECONDARY Change in Genitourinary Pain Index |
-10.5; -15 | — |
| SECONDARY Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale |
-4.5; -9 | — |
| SECONDARY Change in Perceived Urinary Urgency |
-30; -48 | — |
| SECONDARY Change in Perceived Overall Pain |
-25; -46 | — |
| SECONDARY Perceived Ease of Therapeutic Wand Use |
3.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02743962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.