A Randomized Trial Comparing Perioperative Pelvic Floor Physical Therapy to Current Standard of Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
A Randomized Trial Comparing Perioperative Pelvic Floor Physical Therapy to Current Standard of Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
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.
This was a randomized double-blind study. Both subjects and the surgeon performing the surgery as well as the personnel administering questionnaires to patients postoperatively were blinded to the randomization.
Recruitment, Enrollment and Randomization
Patients scheduled to undergo vaginoplasty surgery at Cleveland Clinic Main campus were approached about voluntary participation in this study. This occurred over the phone approximately one to three months before their scheduled surgery. Patients who agreed to participate were sent a consent form via the mail and were asked to sign consent in person. Enrollment and randomization occurred following informed consent. All patients were given a copy of their signed and dated consent.
Once enrolled, patients were randomized into one of two groups:
If patients were randomized into the Postoperative PFPT arm, they were further randomized into the following sub-arms:
Surgery:
All patients underwent vaginoplasty surgery by a single surgeon in a standard fashion. The neovaginal cavity was created using the same technique across all patients. Postoperative care was routine and the same for all patients.
Postoperative Pelvic Floor Physical Therapy:
There was three possible PFPT regimens. All PT regimens were performed by the same two physical therapists, trained in the management of patients who have undergone vaginoplasty surgery.
Patients presented to the physical therapist 3 weeks and 6 weeks postoperatively. The following interventions were performed:
3 weeks:
Subjective assessment of bowel and bladder function
Visual and external palpation and assessment of external pelvic floor region
Intravaginal pelvic floor assessment
Pelvic floor muscle dynamics and coordination assessment
Instruction of pelvic floor coordination and lengthening
Discussion of dilator program and progression
Home program with instructions
6 weeks:
External scar assessment and treatment if tissue healing allows
Instruction to patient of scar mobilizations
Intravaginal pelvic floor assessment and treatment if indicated
Review of pelvic floor lengthening and coordination
Review and progression of dilator program if appropriate
Assessment of current bowel/bladder symptoms; home program and instructions to address these symptoms
3) Preoperative PFPT and Postoperative PFPT:
Patients presented to see the physical therapist 3 weeks before surgery, 3 weeks and 6 weeks postoperatively. The following interventions were performed:
Preoperative:
Diaphragmatic breathing
Discuss dilator positioning/introduce dilator program
External pelvic floor assessment
Teach pelvic floor coordination
Assessment of current bowel/bladder symptoms; home program and instructions to address these symptoms
3 weeks:
Subjective assessment of bowel and bladder function
Visual and external palpation and assessment of external pelvic floor region
Intravaginal pelvic floor assessment
Pelvic floor muscle dynamics and coordination assessment
Instruction of pelvic floor coordination and lengthening
Discussion of dilator program and progression
Home program with instructions
6 weeks:
External scar assessment and treatment if tissue healing allows
Instruction to patient of scar mobilizations
Intravaginal pelvic floor assessment and treatment if indicated
Review of pelvic floor lengthening and coordination
Review and progression of dilator program if appropriate
Assessment of current bowel/bladder symptoms; home program and instructions to address these symptoms
Study Questionnaires & Exams:
All patients were administered questionnaires preoperatively and 12 weeks postoperatively. The following questionnaires were administered:
Preoperatively:
Postoperatively 1 week (at the time of routine dilation teaching):
• Vaginal length (routine exam)
Postoperatively 12 weeks:
Cross-Over Treatment:
Any patients in the No PFPT arm who were determined to have pelvic floor dysfunction or symptoms that may have benefitted from PFPT referral, were referred after the 12-week mark. Any patient in one of the PFPT arms who was determined to still need PFPT for persistent pelvic floor dysfunction or symptoms were referred for continued care.
Inclusion Criteria:
Exclusion Criteria: