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

Who is this study for? Women with interstitial cystitis/Bladder pain syndrome
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Contact Information
Primary
Lydia Kosovich, BSN
Lydia.Kosovich@corewellhealth.org
248-551-3291
Backup
Jennifer Giordano, BSN
Jennifer.Giordano@corewellhealth.org
248-551-3517
Time Frame
Start Date: 2017-04-21
Estimated Completion Date: 2026-08
Participants
Target number of participants: 128
Treatments
Active_comparator: Pelvic Floor Physical Therapy
One hour of pelvic floor physical therapy twice weekly for 8 weeks
Active_comparator: Bladder Instillations
Bladder instillation of lidocaine, kenalog, heparin sulphate, and bicarbonate twice weekly for 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Corewell Health East
Collaborators: Baylor College of Medicine

This content was sourced from clinicaltrials.gov