Lower Urinary Tract Symptoms, Transgenderism
Conditions
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
Interventions
None listed
Sponsors
Chelsea and Westminster NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
17 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty | Baseline, 6 weeks, 12 weeks, 6 months post operatively | 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. |
| Background incidence of LUTS in transmasculine patients undergoing surgery | Baseline, 6 weeks, 12 weeks, 6 months post operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| How do subjective LUTS / objective voiding dysfunction (VD) change after metoidioplasty / vaginectomy / urethral hook up? | Baseline, 6 weeks, 12 weeks, 6 months post operatively | 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. |
Contacts
Primary ContactRufus Cartwright, MA MD(res) PhD MRCOG
Outcome results
None listed