N/A
N=37
Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
Pelvic Floor Disorders
Bottom Line
View on ClinicalTrials.gov: NCT05690555 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Patient Reported Ease of Dilation — 6.6; 7.4; 8.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) (Other); No Pelvic Floor Physical Therapy (PFPT) (Other); Postoperative PFPT (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- The Cleveland Clinic
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Ease of Dilation |
6.6; 7.4; 8.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05690555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.