Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse

NCT06903988 | Active Not Recruiting

• 1 other identifier: 2024PHB374-002
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with Stage III or higher pelvic organ prolapse who are unresponsive to conservative treatment and are requesting surgical treatment. Patients who meet the inclusion and exclusion criteria will be randomly assigned to the transvaginal sacrospinous ligament fixation group and the laparoscopic lateral suspension group in a 1:1 ratio. Follow-ups will be conducted at 1 month, 3 months, 6 months, and 1 year after surgery for the enrolled patients. The primary outcome measure is the difference in surgical success rate between the two groups of patients at 1 year after surgery. We hypothesize that the surgical success rate of laparoscopic lateral suspension is not inferior to that of transvaginal sacrospinous ligament fixation

Conditions

Pelvic Organ Prolapse (POP)

Outcome Measures

Primary Outcomes (1)

• Surgical success rate

  Surgical success is defined as follows: 1. Points Aa, Ba, Ap, and Bp do not exceed the hymenal margin; 2. The descent of point C does not exceed one-third of the total vaginal length; 3. During the follow-up period, the patient does not require pessary treatment or undergo further surgery for pelvic organ prolapse; 4. Questions 3 of the Pelvic Floor Dysfunction Inventory (PFDI)-20 questionnaire are answered as "none" or "no impact."

  From enrollment to the end of surgery at 1 year

Secondary Outcomes (7)

• Incidence of urinary retention after catheter removal

  From enrollment to the end of surgery at 3 days

• Differences in the severity of overactive bladder (OAB) after surgery

  1 month, 3 months, 6 months and 1 year post-surgery

• Differences in the severity of urinary incontinence after surgery

  1 month, 3 months, 6 months and 1 year post-surgery

• Differences in the severity of pelvic floor dysfunction after surgery

  1 month, 3 months, 6 months and 1 year post-surgery

• Differences in quality of life after surgery

  1 month, 3 months, 6 months and 1 year post-surgery

Other Outcomes (6)

• Mesh-related complications

  From enrollment to the end of surgery at 1 year

• Duration of surgery

  Intraoperative

• Blood loss

  From enrollment to the end of surgery at 1 year

Study Arms (2)

laparoscopic lateral suspension

EXPERIMENTAL

Procedure: laparoscopic lateral suspension

transvaginal sacrospinous ligament fixation

ACTIVE COMPARATOR

Procedure: Transvaginal sacrospinous ligament fixation

Interventions

laparoscopic lateral suspension PROCEDURE

Laparoscopic lateral suspension: Place a 1/2 T4 mesh in the vesicovaginal space. The two lateral slings are passed out from the outer upper side of the bilateral anterior superior iliac spine, and the prolapsed organs are suspended to the abdominal wall.

laparoscopic lateral suspension

Transvaginal sacrospinous ligament fixation PROCEDURE

Transvaginal sacrospinous ligament fixation: Dissect the rectovaginal space to expose the right sacrospinous ligament, and fix the cervix or vaginal cuff to the right sacrospinous ligament.

transvaginal sacrospinous ligament fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• According to the POP-Q classification, patients who meet any of the following conditions: a. Patients with anterior wall prolapse of stage III or higher; b. Patients with apical prolapse of stage III or higher;
• Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;
• Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;
• Patients who have received education at the primary school level or above;
• Patients who are able to visit the hospital for examinations;
• Patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment.

You may not qualify if:

• Patients who have previously undergone surgery for pelvic organ prolapse (POP);
• Patients with a history of anti-incontinence surgery or who are planned to undergo mid-urethral sling surgery for anti-incontinence during the current operation;

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 1, 2025
• Study Start: April 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)