Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

Recruiting Phase 2 Phase 3 Interventional Study
High Tone Pelvic Floor Dysfunction
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Michigan · Other
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About This Trial
The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. First, the researchers will compare a muscle relaxant medicine (cyclobenzaprine IR) to using a vibrating pelvic flo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Self-reported moderate to severe chronic pelvic pain for \>6 months duration at time of screening visit. Moderate to severe chronic pain is defined as \>4 on 0-10 (worst daily pain) for \>14 days per month. Pelvic pain is defined as pain perceived to be located in the anatomic…
Contacts

Vilmarie Carmona

269-760-7317

vilmarie@umich.edu

CONTACT