A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome

NCT02743962 | Completed Results

• 1 other identifier: Uni Bradford Protocol 4
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Painful Bladder Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to 6 weeks and 6 to 12 weeks

Secondary Outcomes (5)

• Change in Genitourinary Pain Index

  0 to 12 weeks

• Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale

  0 to 12 weeks

• Change in Perceived Urinary Urgency

  Baseline to 12 weeks

• Change in Perceived Overall Pain

  Baseline to 12 weeks

• Perceived Ease of Therapeutic Wand Use

  0 to 12 weeks

Other Outcomes (1)

• Subjective Reports of Adverse Events

  0 to 12 weeks

Study Arms (2)

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.

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.

Device: Therapeutic Wand

Interventions

Therapeutic Wand DEVICE

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

Therapeutic Wand group

Routine physiotherapy control OTHER

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.

Usual physiotherapy treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bradford: lead

Related Publications (1)

• 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.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

As a feasibility study a small sample was used, which limits interpretation of the data. A single, unblinded assessor was used and participants were also not blinded.

Results Point of Contact

• Title: Hilary Pape
• Organization: University of Bradford

hpape@bradford.ac.uk

01274 236228

Study Officials

• Jilly Bond, MSc

  University of Bradford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Specialist Physiotherapist

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 3, 2018
• Results First Posted: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share