Comparison of Two Surgical Methods for Repairing Pelvic Organ Prolapse in Women Age 50 and Older

What this Trial Is About

Pelvic organ prolapse POP, especially defects in the anterior compartment, significantly affects the quality of life in women. This trial focuses on comparing two surgical methods to repair cystocele, a common type of POP caused mainly by paravaginal defects in vaginal support. The study aims to evaluate the safety and effectiveness of a new minimally invasive surgery called transobturator cystocele repair TOCR against the standard anterior colporrhaphy AR to improve cystocele repair outcomes over one year. Participants will receive either the novel TOCR procedure or the standard AR surgery. TOCR involves a transvaginal approach using continuous non-locking stitches through the obturator membrane and muscle with non-absorbable sutures, followed by closure of the vaginal skin. The AR technique uses a midline vaginal incision to dissect and repair the pubocervical fascia with interrupted sutures and trims excess vaginal tissue. Both groups receive indometacin rectal suppositories for early postoperative pain management. Women in the trial will undergo assessments before and after surgery, including anatomical evaluations of prolapse repair success at 1 and 2 years, complication monitoring, pain assessment 14 days post-surgery, and questionnaires on subjective improvement and quality of life related to urinary and pelvic symptoms. The study includes follow-up visits to measure patient satisfaction and monitor new urinary symptoms. The total follow-up period extends up to two years to observe long-term outcomes and safety.

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS