A randomized trial comparing perioperative pelvic FLOor physical therapy to current standard of care in transgender Women undergoing vaginoplasty for gendER affirmation: the FLOWER Trial.

Introduction And Hypothesis: There are sparse data on the use of postoperative pelvic floor physical therapy (PFPT) in patients undergoing vaginoplasty. The primary objective of this study was to compare the impact of PFPT on the ease of vaginal dilation after vaginoplasty in transgender women. We hypothesized that patients undergoing PFPT would report better ease of vaginal dilation following surgery.

Methods: This was a randomized trial of transgender women undergoing vaginoplasty. Patients were randomized to either no PFPT or PFPT 3 and 6 weeks following surgery. Subjects completed the Pelvic Floor Disorders Inventory and the Pelvic Floor Impact Questionnaire at baseline and at 12 weeks. At 12 weeks, subjects underwent vaginal length measurement and completed the Patient Global Impression of Improvement and a visual analogue scale (0-10) for ease of vaginal dilation and pain with dilation. A total of 17 subjects in each arm were needed to detect a significant difference in ease of dilation between the two groups.

Results: Forty-one subjects were enrolled and 12-week data were available for 37 subjects (20 PFPT, 17 no PFPT). Mean age and BMI were 31 ± 13 years and 24.9 (± 4.0) kg/m. Subjects were on hormone therapy for a median of 39 (20-240) months and 5 (13.5%) patients had undergone previous orchiectomy. At 12 weeks, the median vaginal length was 12.5 (10-16) cm, reported mean ease of dilation was 7.3 (± 1.6), and pain with dilation was 2.4 (± 1.7). There were no differences in these outcomes or in pelvic floor symptoms between the groups.

Conclusions: In this study, routine postoperative PFPT did not improve outcomes in patients undergoing vaginoplasty.