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

Pelvic Floor Disorders Clinical Trial

— FLOWER  

Official title:

A Randomized Trial Comparing Perioperative Pelvic Floor Physical Therapy to Current Standard of Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690555
• Other study ID #: 20-917
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

• Postoperative PFPT

• No Postoperative PFPT

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

• Postoperative PFPT alone

• Preoperative and Postoperative PFPT

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.

1. No PFPT Patients were present to see the physical therapist 3 weeks postoperatively. The following interventions were 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.

2. Postoperative PFPT Only

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:

• CRAD-8 and UDI-6

• PFIQ-7

Postoperatively 1 week (at the time of routine dilation teaching):

• Vaginal length (routine exam)

Postoperatively 12 weeks:

• CRAD-8 and UDI-6

• PFIQ-7

• PGI-I

• Ease of Passing Dilator (VAS 0-10)

• Pain with Dilation (VAS 0-10)

• Largest dilator size used

• Vaginal length (routine exam)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2022
• Est. primary completion date: September 11, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 18 years of age

• Patients scheduled for full-depth vaginoplasty surgery

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Other:
• 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
• 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.
• Preoperative PFPT and 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
• Cross-over Treatment
Any patients in the No PFPT arm who are determined to have pelvic floor dysfunction or symptoms that may benefit from PFPT referral, will be referred after the 12-week mark. Any patient in one of the PFPT arms who is determined to still need PFPT for persistent pelvic floor dysfunction or symptoms will be referred for continued care.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	Severity of pelvic floor dysfunction - CRAD-8	Colorectal-Anal Distress Inventory 8 (CRAD-8) is part of the Pelvic Floor Distress Inventory 20. The CRAD-8 questions are specific to bowel function with responses for symptom bother on a scale of 1-4 with 1 (not at all bothered) to 4 (quite a bit bothered).	12 weeks
Secondary	Severity of pelvic floor dysfunction - UDI-6	Urinary Distress Inventory 6 (UDI-6) is part of the Pelvic Floor Distress Inventory 20. The UDI-6 questions are specific to urinary function with responses for symptom bother on a scale of 1-4 with 1 (not at all bothered) to 4 (quite a bit bothered).	12 weeks
Secondary	Severity of pelvic floor dysfunction - PFIQ-7	Pelvic Floor Impact Questionnaire 7 (PFIQ-7) is a seven question self-report measure assessing pelvic floor impact on QOL, daily activities and emotional health regarding bladder/urine, bowel/rectum and vagina/pelvis. The scale exists from: Not at all, Somewhat, Moderately and Quite a bit.	12 weeks
Secondary	Severity of pelvic floor dysfunction - PGI-I	Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to surgery. The scale exists from 1 (very much better) to 7 (very much worse).	12 weeks
Secondary	Severity of pelvic floor dysfunction - VAS	Visual Analog Scale (VAS) 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).	12 weeks
Secondary	Severity of pelvic floor dysfunction - Largest dilator size used	Vaginal dilator size used with 1 (smallest) and 4 (largest).	12 weeks
Secondary	Severity of pelvic floor dysfunction - Vaginal length	Measurement of the length of the vagina done during routine exam. The average vagina measures 7-10 centimeters.	12 weeks