A Randomized Trial Comparing Perioperative Pelvic Floor Physical Therapy to Current Standard of Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Patient Reported Ease of Dilation
研究概览
简要总结
Currently, perioperative pelvic floor physical therapy (PFPT) is not standard of care for all patients who undergo vaginoplasty surgery. While some practices have implemented these new programs, and the above data exist on outcomes associated with perioperative PFPT in transgender women undergoing vaginoplasty, no study has compared implementation of perioperative PFPT to routine care (no perioperative PFPT). Therefore, the primary objective of this study was to compare the effectiveness of postoperative PFPT compared to no PFPT in transgender women undergoing vaginoplasty surgery for gender affirmation. Secondary objectives of the study are 1) to describe the incidence of preoperative pelvic floor dysfunction in transgender women undergoing PFPT and 2) to compare the effectiveness of postoperative PFPT alone to pre- and postoperative PFPT in these patients.
详细描述
This was a randomized double-blind study. Both subjects and the surgeon performing the surgery as well as the personnel administering questionnaires to patients postoperatively were blinded to the randomization.
Recruitment, Enrollment and Randomization
Patients scheduled to undergo vaginoplasty surgery at Cleveland Clinic Main campus were approached about voluntary participation in this study. This occurred over the phone approximately one to three months before their scheduled surgery. Patients who agreed to participate were sent a consent form via the mail and were asked to sign consent in person. Enrollment and randomization occurred following informed consent. All patients were given a copy of their signed and dated consent.
Once enrolled, patients were randomized into one of two groups:
- Postoperative PFPT
- No Postoperative PFPT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years of age
- •Patients scheduled for full-depth vaginoplasty surgery
排除标准
- •Inability to speak or comprehend the English language
- •Patients scheduled for no-depth vaginoplasty surgery
- •Patients who have undergone previous PFPT
- •Patients who are s/p prostatectomy or treatment for prostate cancer
结局指标
主要结局
Patient Reported Ease of Dilation
时间窗: 12 weeks
VAS 0-10 is a validated 10 item questionnaire. Responses to each question are scored on a 10-point Likert scale, ranging from 0 (no pain) to 10 (worst pain). A response of 10 is considered to be a worse outcome.
Patient Reported Ease of Dilation
时间窗: 12 weeks
VAS 0-10 is a validated 10 item questionnaire. Responses to each question are scored on a 10-point Likert scale, ranging from 0 (no pain) to 10 (worst pain). A response of 10 is considered to be a worse outcome.
次要结局
未报告次要终点