A Randomized Controlled Trial of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse

NANot yet recruitingINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2027

Conditions
Pelvic Organ Prolapse
Interventions
PROCEDURE

sacrospinous ligament fixation (SLFF)

SSLF is a surgical procedure used to treat vaginal apex prolapse by fixing the vaginal apex to the right sacrospinous ligament. The procedure involves marking and incising the posterior vaginal wall, dissecting the vaginal rectal space, and placing sutures on the outer one-third of the ligament. These sutures connect the vaginal apex to the attachment point of the right uterosacral ligament. Anterior/posterior vaginal wall repair procedures can be performed if needed, without using implant materials. SSLF provides enhanced support for the vaginal apex.

PROCEDURE

modified ischial spinous fascia fixation (modified ISFF)

The modified ISFF procedure involves making a midline incision along the posterior fornix of the vagina, exposing the ischial spine fascia. Two sutures are placed around the ischial spine and passed through the mucosa of the anterior and posterior vaginal walls, lifting the vaginal apex and anterior wall towards the spine. The procedure also allows for additional anterior/posterior vaginal wall repair if necessary, without using implant materials.

All Listed Sponsors
lead

Lan Zhu

OTHER

NCT06418451 - A Randomized Controlled Trial of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse | Biotech Hunter | Biotech Hunter