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

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.

Conditions

• Pelvic Floor Disorders

Interventions

OTHER

Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)

Patients will present to see the physical therapist 3 weeks and 6 weeks postoperatively. The following interventions will be 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

OTHER

No Pelvic Floor Physical Therapy (PFPT)

Patients will present to see the physical therapist 3 weeks postoperatively. The following interventions will be performed: 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. Review of pelvic floor anatomy and function.

OTHER

Postoperative PFPT

Preoperative Diaphragmatic breathing Discuss dilator positioning/introduce dilator program External pelvic floor assessment Teach pelvic floor coordination Current bowel/bladder symptoms; home program and instructions 3 weeks 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 Current symptoms; home program and instructions

Sponsors & Collaborators

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Cecile Ferrando, M.D. · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-25

Primary Completion

2022-09-11

Completion

2022-12-31

Countries

• United States

Study Locations