Lower Urinary Tract Symptoms in Transmasculine Patients Undergoing Metoidioplasty and Their Accep… (NCT06956989) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Lower Urinary Tract Symptoms in Transmasculine Patients Undergoing Metoidioplasty and Their Acceptability of Pelvic Floor Muscle Training Assessed by a Pelvic, Obstetric and Gynaecological Physiotherapist
50 participantsStarted 2025-08
Plain-language summary
Lower urinary tract symptoms in transmasculine patients undergoing metoidioplasty and their acceptability of pelvic floor muscle training assessed by a Pelvic, Obstetric and Gynaecological Physiotherapist.
Study Design
Prospective observational pilot study
Study Participants
Transmasculine patients undergoing metoidioplasty
Planned Sample Size
50
Planned Study Period
2025/26
Objectives
Understand the acceptability of first-line pelvic floor muscle training (PFMT) treatment in transmasculine patients undergoing metoidioplasty
Background incidence of lower urinary tract symptoms (LUTS) in transmasculine patients undergoing surgery
Endpoints
Acceptability of PFMT questionnaire
International Prostate Symptom Score (I-PSS) and International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) questionnaires and uroflowmetry
Who can participate
Age range
17 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Have capacity to consent.
Diagnosis of gender dysphoria and have lived in a gender role that is congruent to their gender identity for minimum of 12 months.
Transmasculine patients referred to CCGS for masculinising lower genital reconstructive surgery having received two signatures confirming suitability for reconstructive surgery.
Undergoing metoidioplasty/phalloplasty.
Age \>17 years old.
On systemic testosterone therapy for more than 12 months.
Exclusion Criteria:
* Age less than 18 years.
Not undergoing metoidioplasty/phalloplasty.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty
Timeframe: Baseline, 6 weeks, 12 weeks, 6 months post operatively
2
Background incidence of LUTS in transmasculine patients undergoing surgery
Timeframe: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Trial details
NCT IDNCT06956989
SponsorChelsea and Westminster NHS Foundation Trust