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Pelvic Floor DisordersFLOWERNCT05690555

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

A study testing Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT), No Pelvic Floor Physical Therapy (PFPT) and Postoperative PFPT in people with Pelvic Floor Disorders, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Pelvic Floor Disorders
What is being tested?
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT), No Pelvic Floor Physical Therapy (PFPT) and Postoperative PFPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
25 Sep 2020to 31 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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.

Read the 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.

  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
  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.

Being tested
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT), No Pelvic Floor Physical Therapy (PFPT), Postoperative PFPT
Medical subject headings
Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
  • 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.

  • Postoperative PFPTOther

    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

Study groups in NCT05690555
Study groupRoleWhat they receive
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)ExperimentalIf patients were randomized into the PFPT arm, they were further randomized into the following sub-arms: Preoperative and Postoperative PFPT
Receives: Other: Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)
Postoperative Pelvic Floor Physical Therapy (PFPT)Active comparatorPatients 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.
Receives: Other: Postoperative PFPT
No Pelvic Floor Physical Therapy (PFPT)Active comparatorPatients were not assigned to physical therapy.
Receives: Other: No Pelvic Floor Physical Therapy (PFPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start25 Sep 2020
  3. Primary completion11 Sep 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05690555
Sponsor's protocol ID
20-917
Acronym
FLOWER
Status last verified
Jul 2025
First submitted
10 Jan 2023
Last updated
15 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT), No Pelvic Floor Physical Therapy (PFPT) and Postoperative PFPT in people with Pelvic Floor Disorders, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Reported Ease of Dilation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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