CompletedNot Applicable

Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation

United States37 participantsStarted 2020-09-25

Plain-language summary

Currently, perioperative pelvic floor physical therapy (PFPT) is not standard of care for all patients who undergo vaginoplasty surgery. While some practices have implemented these new programs, and the above data exist on outcomes associated with perioperative PFPT in transgender women undergoing vaginoplasty, no study has compared implementation of perioperative PFPT to routine care (no perioperative PFPT). Therefore, the primary objective of this study was to compare the effectiveness of postoperative PFPT compared to no PFPT in transgender women undergoing vaginoplasty surgery for gender affirmation. Secondary objectives of the study are 1) to describe the incidence of preoperative pelvic floor dysfunction in transgender women undergoing PFPT and 2) to compare the effectiveness of postoperative PFPT alone to pre- and postoperative PFPT in these patients.

Who can participate

Age range18 Years

SexMALE

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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: * Age greater than or equal to 18 years of age * Patients scheduled for full-depth vaginoplasty surgery Exclusion Criteria: * Inability to speak or comprehend the English language * Patients scheduled for no-depth vaginoplasty surgery * Patients who have undergone previous PFPT * Patients who are s/p prostatectomy or treatment for prostate cancer

What they're measuring

Patient Reported Ease of Dilation

Timeframe: 12 weeks

Trial details

NCT IDNCT05690555

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-11

Results submitted2023-11-21

View on ClinicalTrials.gov More Pelvic Floor Disorders trials