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临床试验/NCT03293771
NCT03293771Unknown不适用

Assessment of Postoperative Urologic and Pelvic Floor Complaints in Male-to-female Transgender Patients: a Mixed Methods Study

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年12月27日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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