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

NCT06956989 | Not Yet Recruiting

• 1 other identifier: 336081
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Lower Urinary Tract Symptoms; Transgenderism

Outcome Measures

Primary Outcomes (2)

• Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty

  Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable. International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms. Uroflowmetry - baseline QMAX vs QMAX post procedure.

  Baseline, 6 weeks, 12 weeks, 6 months post operatively

• Background incidence of LUTS in transmasculine patients undergoing surgery

  Acceptability of pelvic floor muscle training questionnaire - bespoke unvalidated qualitative questionnaire looking at acceptability of different PFMT techniques on a 0-10 VAS scale. Zero not acceptable, ten very acceptable. International prostate symptom score. Seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaires. Question items: Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item. Scoring scale: 0-21. Higher score = worse symptoms. Uroflowmetry - baseline QMAX vs QMAX post procedure.

  Baseline, 6 weeks, 12 weeks, 6 months post operatively

Secondary Outcomes (2)

• How well do the I-PSS and ICIQ SF function as measures of LUTS and LUTS specific Quality of Life (QoL) for transmen?

  Baseline, 6 weeks, 12 weeks, 6 months post operatively

• How do subjective LUTS / objective voiding dysfunction (VD) change after metoidioplasty / vaginectomy / urethral hook up?

  Baseline, 6 weeks, 12 weeks, 6 months post operatively

Eligibility Criteria

• Age: 17 Years+
• Gender Eligibility Details: Transgender men
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be transmasculine patients undergoing metoidioplasty

You may qualify if:

• 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.

You may not qualify if:

• Age less than 18 years.
• Not undergoing metoidioplasty/phalloplasty.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Transsexualism

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Central Study Contacts

Rufus Cartwright, MA MD(res) PhD MRCOG

CONTACT

0203315800; rufus.cartwright@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 4, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-04