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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT05690555

Collaborator

(none)

Enrollment

Location

Arms

27.2

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders	Other: Pelvic Floor Physical Therapy (PFPT) Other: No Pelvic Floor Physical Therapy (PFPT) Other: Preoperative PFPT and Postoperative PFPT Other: Cross-over Treatment	N/A

Detailed 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.

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.
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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 25, 2020

Actual Primary Completion Date :

Sep 11, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Postoperative Pelvic Floor Physical Therapy (PFPT) If patients were randomized into the Postoperative PFPT arm, they were further randomized into the following sub-arms: Postoperative PFPT alone and Preoperative and Postoperative PFPT	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 Other: 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
Active Comparator: No Postoperative 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: 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: 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.

Arm

Intervention/Treatment

Experimental: Postoperative Pelvic Floor Physical Therapy (PFPT)

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

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

Other: 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

Active Comparator: No Postoperative 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: No Pelvic Floor Physical Therapy (PFPT)

Other: 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.

Outcome Measures

Primary Outcome Measures

Patient reported ease of dilation [12 weeks]
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).

Secondary Outcome Measures

Severity of pelvic floor dysfunction - CRAD-8 [12 weeks]
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).
Severity of pelvic floor dysfunction - UDI-6 [12 weeks]
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).
Severity of pelvic floor dysfunction - PFIQ-7 [12 weeks]
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.
Severity of pelvic floor dysfunction - PGI-I [12 weeks]
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).
Severity of pelvic floor dysfunction - VAS [12 weeks]
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).
Severity of pelvic floor dysfunction - Largest dilator size used [12 weeks]
Vaginal dilator size used with 1 (smallest) and 4 (largest).
Severity of pelvic floor dysfunction - Vaginal length [12 weeks]
Measurement of the length of the vagina done during routine exam. The average vagina measures 7-10 centimeters.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Cecile Ferrando, M.D., The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT05690555

Other Study ID Numbers:

20-917

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pelvic Floor Disorders

Study Results

No Results Posted as of Jan 23, 2023