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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Age less than 18 years.
- •Not undergoing metoidioplasty/phalloplasty.
结局指标
主要结局
Understand the acceptability of first-line PFMT treatment in transmasculine patients undergoing metoidioplasty
时间窗: 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
时间窗: 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.
次要结局
- How do subjective LUTS / objective voiding dysfunction (VD) change after metoidioplasty / vaginectomy / urethral hook up?(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?(Baseline, 6 weeks, 12 weeks, 6 months post operatively)