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Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

StatusRecruiting
PhasePhase 2/3
Started2026-02-18
View on ClinicalTrials.gov ↗

Amendment history

2026-02-18
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-02→confirmed 2026-02-18
Study sitesdetails revised at 1 of 1 site
2026-02-04
minor
Original filing
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 floor massage wand. Everyone in the study will also do pelvic floor physical therapy. The researchers want to see how these treatments affect pain, sexual health, physical ability, and overall quality of life.
Trial Details
NCT Number NCT07404397
Lead Sponsor University of Michigan
Collaborators: The American Association of Obstetricians and Gynecologists Foundation
Conditions High Tone Pelvic Floor Dysfunction
Enrollment 60 participants
Start Date 2026-02-18
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-20