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NCT05690555 · ClinicalTrials.gov registry record · NA
Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
A NA study of Pelvic Floor Disorders, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT05690555: Completed NA study of Pelvic Floor Disorders, sponsored by The Cleveland Clinic.
NCT05690555 is a NA study of Pelvic Floor Disorders that has completed, run by The Cleveland Clinic. The registered enrollment target is 37 participants, below the 113-participant average among 11 other Pelvic Floor Disorders trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05690555, a NA study of Pelvic Floor Disorders, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT)
- OTHER No Pelvic Floor Physical Therapy (PFPT)
- OTHER Postoperative PFPT
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-09-25 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
What the finished NCT05690555 record still lists
NCT05690555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 113-participant average among 11 other Pelvic Floor Disorders trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Pelvic Floor Disorders appearing as the primary indexed condition, and to 3 interventions - of which Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) is the first listed.
NCT05690555 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05690555 about?
NCT05690555 is a clinical study titled "Pelvic Floor Physical Therapy vs Standard 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 v...
What is the current status of trial NCT05690555?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2020-09-25. Estimated completion is 2022-12-31.
What conditions does trial NCT05690555 study?
This clinical trial studies the following conditions: Pelvic Floor Disorders.
What interventions are being tested in trial NCT05690555?
The interventions under investigation include: Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT) (OTHER), No Pelvic Floor Physical Therapy (PFPT) (OTHER), Postoperative PFPT (OTHER).
Who is sponsoring clinical trial NCT05690555?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05690555 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pelvic Floor Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05690555's enrollment target sits among peer trials
37 10th of 11 higher than 2 of 11 other Pelvic Floor Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Floor Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
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-
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