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ACTIVE NOT RECRUITING
NCT02870738
PHASE2

Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

Sponsor: Corewell Health East

View on ClinicalTrials.gov

Summary

Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem, tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in treatment and often years of suffering. This clinical trial will test a bladder directed therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT) to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and allow for early, more effective treatment.

Official title: Comparison of Bladder Directed and Pelvic Floor Therapy in Women With Interstitial Cystitis/Bladder Pain Syndrome

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2017-04-21

Completion Date

2026-08

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

PROCEDURE

Pelvic Floor Physical Therapy

Internal and/or external myofascial release of the pelvic floor muscles

DRUG

Bladder Instillations

A solution of heparin sulphate 40,000 IU (4 cc of 10,000 units/cc), lidocaine 2% 16 ml, Sodium bicarbonate 8.4% 4 ml and Kenalog 40 mg (1cc) to reach a total fluid volume of 25 ml will be instilled into the bladder with a urinary catheter

Locations (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States