Pelvic floor therapy may beat bladder treatments for chronic pain
NCT ID NCT02870738
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study looks at two treatments for women with painful bladder syndrome: bladder instillations (medication put directly into the bladder) and pelvic floor physical therapy (exercises to relax tight muscles). The goal is to see which works better to reduce pain and urinary symptoms. 128 women aged 18-85 with symptoms for at least 6 months are being studied over 9 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2017
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 exercises is not exclusionary) * Participant in the opinion of the investigator has a relevant neurologic disorder that affects bladder and/or neuromuscular function * Participant has/reports any severe, debilitating or urgent concurrent, medical condition * Participant has a potentially significant pelvic pathology or abnormality on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc., that in the investigators' judgment, could cause or contribute to the clinical symptoms, or require treatment * Any other condition which, in the investigator's judgment, may increase risk to subject's welfare * Participation in an investigational trial that uses a study treatment less than 6 months from the date of the screening visit Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
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Other studies related to the condition(s) this trial covers.
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