An observational study in Lower Urinary Tract Symptoms and Transgenderism, sponsored by Chelsea and Westminster NHS Foundation Trust. Not yet recruiting. Open to female participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational
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
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 50 is below the median of 153 across 131 observational studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants will be transmasculine patients undergoing metoidioplasty
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Not undergoing metoidioplasty/phalloplasty.
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.
Time frame: 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.
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
How well do the I-PSS and ICIQ SF function as measures of LUTS and LUTS specific Quality of Life (QoL) for transmen?
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.
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?
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.
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post operatively
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Aug 2026, 12 months later.
Of 56 non-industry observational studies under Lower Urinary Tract Symptoms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 70. This study's planned 12 months is below that.
Counting every sponsor, half of 61 studies reached it within 33 months; a quarter within 11 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Lower Urinary Tract Symptoms →
Chelsea and Westminster NHS Foundation Trust