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

NeuroTherapia, Inc.

Status

Completed

Conditions

Pelvic Floor Disorders

Treatments

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

Other: No Pelvic Floor Physical Therapy (PFPT)

Other: Postoperative PFPT

Study type

Interventional

Funder types

Other

Identifiers

NCT05690555

20-917

Details and patient eligibility

About

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.

Full 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
1. 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.

Enrollment

37 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

37 participants in 3 patient groups

Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)

Experimental group

Description:

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

Treatment:

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

Postoperative Pelvic Floor Physical Therapy (PFPT)

Active Comparator group

Description:

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.

Treatment:

Other: Postoperative PFPT

No Pelvic Floor Physical Therapy (PFPT)

Active Comparator group

Description:

Patients were not assigned to physical therapy.

Treatment:

Other: No Pelvic Floor Physical Therapy (PFPT)

Trial documents