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

NCT ID: NCT06956989

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Lower Urinary Tract Symptoms Transgenderism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Rufus Cartwright, MA MD(res) PhD MRCOG

Role: CONTACT

0203315800

Other Identifiers

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336081

Identifier Type: -

Identifier Source: org_study_id

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