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Not yet recruiting 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

Observational Lower Urinary Tract Symptoms Transgenderism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lower Urinary Tract Symptoms, Transgenderism. Basic parameters: from 17 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty [Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively]
  • Background incidence of LUTS in transmasculine patients undergoing surgery [Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively]
Secondary outcome measures (2)
  • How well do the I-PSS and ICIQ SF function as measures of LUTS and LUTS specific Quality of Life (QoL) for transmen? [Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively]
  • How do subjective LUTS / objective voiding dysfunction (VD) change after metoidioplasty / vaginectomy / urethral hook up? [Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06956989 · 336081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗