Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Stage 1: Focus groups
研究概览
简要总结
The intent of this mixed methods study for transgender women after gender confirmation surgery is to characterize and subsequently create a validated screening questionnaire for postoperative urologic and pelvic floor symptoms. For individuals who seek gender-confirming treatment, about 13% undergo genital surgery for cosmetic purposes with or without gonadectomy, and this number is increasing. Patient satisfaction following surgery is high, particularly regarding sexual and cosmetic outcomes; however, unexpected negative functional outcomes such as bowel and bladder dysfunction and pelvic organ prolapse impact overall patient satisfaction. The available information suggests that 16-33% of patients experience incontinence postoperatively, with stress predominance, 32-47% experience abnormal voiding, and 24-66% experience overactive bladder symptoms. Outside of the typically assessed voiding symptoms, unique complaints of MTF postoperative patients include obstructive voiding symptoms due to urethral stenosis, persistent perimeatal erectile tissue, prostatic hypertrophy, and irritation from neovaginal tissue. Additionally, may of these patients develop symptomatic neovaginal prolapse, requiring re-suspension. We suggest that further clarification regarding MTF postoperative urologic and pelvic floor complaints can be achieved via a mixed methods approach. By using focus group interviews to create specific evaluative questions for this unique population, we can then prospectively assess patients undergoing surgery via a national multicenter sampling strategy. The goal of the study is to better understand the unique symptoms these women experience and create a validated, reliable screening questionnaire to monitor patients after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Stage 1 -- Male-to-female transgender women who are at least 4 weeks postoperative following genital surgery for gender confirmation
- •Stage 2 -- Male-to-female transgender women who are scheduled to undergo surgery or are within 4 weeks postoperative
- •Both stages -- Minimum age 18 years old
- •Both stages -- English fluency
- •Both stages -- Reliable contact information and/or permanent residence
排除标准
- •Preexisting pelvic pathology, including abnormal anatomy or baseline voiding dysfunction
- •Urinary or intestinal problems prior to surgery lasting greater than 6 weeks
结局指标
主要结局
Stage 1: Focus groups
时间窗: 3 months
Characterization of genital, urologic, bowel, and sexual symptoms following male-to-female gender confirmation surgery
Stage 2: Questionnaire testing
时间窗: 12 months
Validity and reliability testing of new questionnaire
次要结局
- Frequency and severity of symptoms(15 months)
- Effect of hormonal therapy usage and symptoms(15 months)
- Relationship between surgical technique and symptoms(15 months)
- Length of time since surgery and development of symptoms(15 months)
