A RCT of direct- versus indirect bilateral- sacrospinous ligament fixation for surgical correction of apical prolapse stage 2 or more. - SDI Trial, Sacrospinous ligament fixation: Direct or Indirect

Academisch Medisch Centrum0 个研究点目标入组 95 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•1. Subject is female;
•2. Subject is least 18 years of age;
•3. Subject has at least a stage 2 apical prolapse and is planned to undergo vaginal surgical correction.

•1. Subjects who are pregnant or want to become pregnant;
•2. Subjects who are not capable of giving informed consent;
•3. Subject has a known sensitivity to polypropylene;
•4. Subject has an indication for a concomitant procedure to treat SUI;
•5. Subject is known with pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical);
•6. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis;
•7. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit).

发起方