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

NCT05690555 | Completed Results

• 1 other identifier: 20-917
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Patient Reported Ease of Dilation

  VAS 0-10 is a validated 10 item questionnaire. Responses to each question are scored on a 10-point Likert scale, ranging from 0 (no pain) to 10 (worst pain). A response of 10 is considered to be a worse outcome.

  12 weeks

Study Arms (3)

Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)

EXPERIMENTAL

If patients were randomized into the PFPT arm, they were further randomized into the following sub-arms: Preoperative and Postoperative PFPT

Other: Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)

Postoperative Pelvic Floor Physical Therapy (PFPT)

ACTIVE COMPARATOR

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

No Pelvic Floor Physical Therapy (PFPT)

ACTIVE COMPARATOR

Patients were not assigned to physical therapy.

Other: No Pelvic Floor Physical Therapy (PFPT)

Interventions

Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) OTHER

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

Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)

No Pelvic Floor Physical Therapy (PFPT) OTHER

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.

No Pelvic Floor Physical Therapy (PFPT)

Postoperative PFPT OTHER

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

Postoperative Pelvic Floor Physical Therapy (PFPT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender women are individuals who were assigned male at birth (are biologically male), but identify as female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years of age
• Patients scheduled for full-depth vaginoplasty surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Results Point of Contact

• Title: Cecile Ferrando, M.D.
• Organization: Cleveland Clinic

ferranc2@ccf.org

216-444-0642

Study Officials

• Cecile Ferrando, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: September 25, 2020
• Primary Completion: September 11, 2022
• Study Completion: December 31, 2022
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-07

Locations

US (1)