NCT05690555: FLOWER

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

Completed NA Results posted Last updated 15 July 2025

What this trial tests

NA trial testing Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) in Pelvic Floor Disorders in 37 participants. Completed in 31 December 2022.

Timeline

25 September 2020

Primary endpoint
11 September 2022

31 December 2022

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	37
Start date	25 September 2020
Primary completion	11 September 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)
• No Pelvic Floor Physical Therapy (PFPT)
• Postoperative PFPT

Conditions studied

• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →

Sponsor

The Cleveland Clinic

Who can join

18 and older, male only, with Pelvic Floor Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Reported Ease of Dilation Primary · 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). A response of 10 is considered to be a worse outcome.

Group	Value	95% CI
Postoperative Pelvic Floor Physical Therapy (PFPT)	6.6	± 1.9
No Postoperative Pelvic Floor Physical Therapy (PFPT)	7.4	± 1.7
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)	8.0	± 0.8

Severity of Pelvic Floor Dysfunction Based on PGI-I Secondary · 12 weeks

The 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 before beginning treatment on a scale from 1 (very much better) to 7 (very much worse). A score of 7 is considered to be a worse outcome.

Group	Value	95% CI
Postoperative Pelvic Floor Physical Therapy (PFPT)	1.4	± 0.7
No Postoperative Pelvic Floor Physical Therapy (PFPT)	1.65	± 1.49
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)	1.9	± 1.3

Mean Difference in CRADI-8 Score Secondary · 12 weeks

Colorectal-Anal Distress Inventory (CRADI-8) provides a symptom inventory (no or yes) and if yes (to measure the degree of bother and distress) caused by the broad array of pelvic floor symptoms, in particular colorectal-anal distress. Responses to the eight questions are scored on a 4-point Likert scale, ranging 1 (not at all) to 4 (quite a bit). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The reported outcome for this trial is the mean difference in score. A high

Group	Value	95% CI
Postoperative Pelvic Floor Physical Therapy (PFPT)	-0.6	± 3.69
No Postoperative Pelvic Floor Physical Therapy (PFPT)	-3.00	± 7.37
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)	-1.9	± 7.58

Mean Difference UDI-6 Score Secondary · 12 weeks

Urinary Distress Inventory (UDI-6) - The UDI-6 is a 6-item questionnaire. Each item is scored on a scale of 0 to 3, with 0 being "not at all" and 3 being "greatly". The average score is calculated and multiplied by 33 1/3 to give a score on a scale of 0 to 100. A higher score indicates a higher level of disability. The outcome measure reported in this trial is the mean difference in scores pre- and post-intervention. A higher UDI-6 score indicates a greater level of disability. It reflects more significant challenges in daily activities and functioning. A score of 100 is considered to be a wor

Group	Value	95% CI
Postoperative Pelvic Floor Physical Therapy (PFPT)	-1.5	± 14.6
No Postoperative Pelvic Floor Physical Therapy (PFPT)	-1.41	± 7.14
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)	-6.5	± 32.02

Mean Difference PFIQ-7-Bladder Score Secondary · 12 weeks

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a seven-question survey that measures the impact of pelvic floor disorders on quality of life, daily activities, and emotional health. The PFIQ-7 is scored on a scale of 0-300. The mean of each of the three scales is calculated, ranging from 0-3. Each mean is multiplied by 100 and then divided by 3. The scale scores are added together to get the total PFIQ-7 score. The reported outcome measure in this trial is the mean difference in this score pre- and post-intervention. A higher PFIQ-7 score indicates a greater level of disability. It reflec

Group	Value	95% CI
Postoperative Pelvic Floor Physical Therapy (PFPT)	6.7	± 22.99
No Postoperative Pelvic Floor Physical Therapy (PFPT)	-1.64	± 10.45
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)	-4.8	± 18.4

Mean Difference in PFIQ-7-Rectum Score Secondary · 12 weeks

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a seven-question survey that measures the impact of pelvic floor disorders on quality of life, daily activities, and emotional health. The PFIQ-7 is scored on a scale of 0-300. The mean of each of the three scales is calculated, ranging from 0-3. Each mean is multiplied by 100 and then divided by 3. The scale scores are added together to get the total PFIQ-7 score. The reported outcome measure in this trial is the mean difference in this score pre- and post-intervention. A score of 300 is considered to be a worse outcome.

Group	Value	95% CI
Postoperative Pelvic Floor Physical Therapy (PFPT)	6.2	± 23.21
No Postoperative Pelvic Floor Physical Therapy (PFPT)	-3.17	± 11.31
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)	0.5	± 3.69

Mean Difference in PFIQ-7-Vagina Score Secondary · 12 weeks

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a seven-question survey that measures the impact of pelvic floor disorders on quality of life, daily activities, and emotional health. The PFIQ-7 is scored on a scale of 0-300. The mean of each of the three scales is calculated, ranging from 0-3. Each mean is multiplied by 100 and then divided by 3. The scale scores are added together to get the total PFIQ-7 score. The reported outcome measure in this trial is the mean difference in this score pre- and post-intervention. A higher PFIQ-7 score indicates a greater level of disability. It reflec

Group	Value	95% CI
Postoperative Pelvic Floor Physical Therapy (PFPT)	6.3	± 27.65
No Postoperative Pelvic Floor Physical Therapy (PFPT)	5.65	± 18.18
Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)	3.5	± 15.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.