Active — Not RecruitingPhase 2

Bladder Directed vs. Pelvic Floor Therapy in IC/BPS

United States128 participantsStarted 2017-04-21

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * Age 18 to 85 years * History of patient self-reported of IC/BPS symptoms for at least 6 months. * Using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past 12 months * Must be willing to not start any new medication known to affect bladder or muscle function, and to ideally remain on a stable dose of all other medications through the secondary endpoint. Exclusion Criteria: * Active urethral or ureteral calculi, urethral diverticulum, history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ (bladder), urethral cancer * Hunner's lesions found on screening cystoscopy * Prior investigational or therapeutic bladder instillations for IC/BPS symptoms within the past 3 months * Lactation, pregnancy, or refusal of medically approved/reliable birth control in women of child-bearing potential. * Pain, frequency, and/or urgency symptoms only present during menses * Clinically confirmed urinary tract infection at time of screening * Participant unable to tolerate insertion of one or two vaginal examining fingers (e.g. Vulvar allodynia) * Participant had prior course of physical therapy (PT) that included internal (vaginal and/or rectal) manual therapy with connective tissue manipulation by physical therapist for the same symptoms within the past 3 months (prior treatment by therapist with biofeedback, electrical stimulation, or pelvic floor exerci…

What they're measuring

Markedly/Moderately Improved on Global Response Assessments

Timeframe: Week 9 (one week after last treatment)

Trial details

NCT IDNCT02870738

SponsorCorewell Health East

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-03