跳至主要内容
临床试验/CTRI/2025/09/094326
CTRI/2025/09/094326尚未招募3 期

Labia minora vs buccal mucosal graft urethroplasty in female urethral strictures. A prospective, parallel arm, non inferiority, Randomized controlled trial.

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Qmax in patients undergoing urethroplasty in either arm in the post surgery

研究概览

简要总结

Female urethral strictures FUS are rare but clinically significant, leading to bothersome lower urinary tract symptoms LUTS, recurrent UTIs, and poor quality of life. Endoscopic treatments such as repeated dilatation offer limited long-term efficacy, making urethroplasty the definitive management option. Among reconstructive choices both flap and graft urethroplasties have been described with oral buccal mucosa and genital labia minora tissues being the most widely studied graft sources.

Buccal mucosal graft BMG urethroplasty has been established as a reliable technique with high success rates and durable functional outcomes. However, harvesting BMG is associated with early donor site morbidities such as pain, bleeding, and swelling, and potential long-term complications including changes in speech, smile, chewing ability, paraesthesia, and trismus. These drawbacks are particularly relevant in women of reproductive and working age, where cosmetic, functional, and quality-of-life concerns carry significant weight.

Labia minora graft LMG urethroplasty, first described by Gozzi and later supported by Rehder and others, offers a well-vascularized, non keratinized, moist epithelial surface that is histologically similar to buccal mucosa. It is hairless, elastic, and easier to harvest in the same operative field, allowing a single surgical team to perform both graft harvest and urethral reconstruction. Importantly, LMG avoids the morbidity associated with oral graft harvest and has shown promising results in terms of Qmax improvement, PVR reduction, and symptom relief in small series.

Given the lack of consensus on the optimal graft material for FUS and the potential advantages of labia minora grafts in minimizing donor-site morbidity while maintaining functional efficacy, a direct comparison between BMG and LMG urethroplasty is both timely and clinically relevant. Our study is designed to evaluate whether labia minora graft urethroplasty is non-inferior to buccal mucosal graft urethroplasty in restoring urinary function, with the added benefit of reducing donor-site complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Inclusion criteria include age over 18-45 years of reproductive age group with diagnosis of primary urethral stricture disease with the following features
  • Calibration less than 14 Fr.
  • Qmax less than 12 ml/s
  • PdetQmax greater than 40 cm H20 in UDS.

排除标准

  • Menopausal age group.
  • Any recurrent cases.
  • Any bleeding diathesis.
  • ASA grade 3 or higher
  • Any chronic disease like CLD or CKD.
  • Anti-coagulation therapy.

结局指标

主要结局

Qmax in patients undergoing urethroplasty in either arm in the post surgery

时间窗: 1st 3rd and 6th month post surgery

次要结局

  • To measure the(BOOI on UDS)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Manoj Das

AIIMS Bhubaneswar

研究点 (1)

Loading locations...

相似试验