Clinical trial NCT06956989: 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
Official title: 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 type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lower Urinary Tract Symptoms
Transgenderism
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be transmasculine patients undergoing metoidioplasty

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


Eligibility criteria: 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.

Primary outcomes:
measure: Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
measure: Background incidence of LUTS in transmasculine patients undergoing surgery
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Secondary outcomes:
measure: How well do the I-PSS and ICIQ SF function as measures of LUTS and LUTS specific Quality of Life (QoL) for transmen?
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
measure: How do subjective LUTS / objective voiding dysfunction (VD) change after metoidioplasty / vaginectomy / urethral hook up?
timeFrame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
Other outcomes:
Locations:
Study officials:
References: