NCT05189665

the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.

Detailed description

Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Extraperitoneal high sacral ligament suspension surgery	The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .
PROCEDURE	Sacrospinous ligament fixation	The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-12-01
• Completion: 2023-04-01
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

1 site across 1 country: China