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Completed
NCT05690555
Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
Conditions: Pelvic Floor Disorders
Sex: Male
Ages: 18 Years – N/A
Phase: NA
Enrollment: 41
Sponsor: The Cleveland Clinic
Location: United States
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 agePatients scheduled for full-depth vaginoplasty surgeryExclusion Criteria:Inability to speak or comprehend the English languagePatients scheduled for no-depth vaginoplasty surgeryPatients who have undergone previous PFPTPatients who are s/p prostatectomy or treatment for prostate cancer
Source: ClinicalTrials.gov (NCT05690555). StuddyBuddy aggregates publicly available trial information.