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

A Randomized Controlled Study on the Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse (POP)
• Intervention / Treatment: Procedure: laparoscopic lateral suspension; Procedure: Transvaginal sacrospinous ligament fixation

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. 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;
3. Patients who refuse conservative treatment or have ineffective conservative treatment and request surgical treatment for prolapse;
4. Patients who voluntarily participate in this study, sign the informed consent form, and are able to attend follow-up visits on time;
5. Patients who have received education at the primary school level or above;
6. Patients who are able to visit the hospital for examinations;
7. Patients who are deemed fit to undergo surgery according to preoperative anesthesia assessment.

Exclusion Criteria:

1. Patients who have previously undergone surgery for pelvic organ prolapse (POP);
2. 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;
3. Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic lateral suspension	Procedure: laparoscopic lateral suspension; 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.
Active Comparator: transvaginal sacrospinous ligament fixation	Procedure: Transvaginal sacrospinous ligament fixation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	Surgical success is defined as follows: Points Aa, Ba, Ap, and Bp do not exceed the hymenal margin;; The descent of point C does not exceed one-third of the total vaginal length;; During the follow-up period, the patient does not require pessary treatment or undergo further surgery for pelvic organ prolapse;; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urinary retention after catheter removal	A residual urine volume greater than 100 ml as measured by ultrasound is considered urinary retention.	From enrollment to the end of surgery at 3 days
Differences in the severity of overactive bladder (OAB) after surgery	It will be assessed by using the Overactive Bladder Symptom Score (OABSS). The score of OABSS ranges from 0 to 15. The higher the score, the more severe the overactive bladder condition is.	1 month, 3 months, 6 months and 1 year post-surgery
Differences in the severity of urinary incontinence after surgery	It will be assessed by using the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). The score of ICIQ-SF ranges from 0 to 21. The higher the score, the more severe the urinary incontinence condition is.	1 month, 3 months, 6 months and 1 year post-surgery
Differences in the severity of pelvic floor dysfunction after surgery	It will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20).The score of PFDI-20 ranges from 0 to 300. The higher the score, the more severe the pelvic floor dysfunction is.	1 month, 3 months, 6 months and 1 year post-surgery
Differences in quality of life after surgery	It will be assessed using the Pelvic Floor Impact Questionnaire (PFIQ).The score of PFIQ ranges from 0 to 300. The higher the score, the poorer the patient's quality of life is.	1 month, 3 months, 6 months and 1 year post-surgery
Differences in patients' satisfaction	It will be assessed using the Patient Global Impression of Improvement (PGI-I) questionnaire. The score of PGI-I ranges from 0 to 7. The higher the score, the lower the patient's satisfaction is.	1 month, 3 months, 6 months and 1 year post-surgery
Postoperative Pain	It will be assessed using the Wong-Baker Faces Pain Rating Scale (FPS-R). The score of FPS-R ranges from 0 to 10. The higher the score, the more severe the pain is.	1 month, 3 months, 6 months and 1 year post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesh-related complications	The Category-Time-Section (CTS) classification is used to document the location, timing, and type of mesh-related complications.	From enrollment to the end of surgery at 1 year
Duration of surgery	We record the duration of surgery (hours) based on the anesthesia record sheet.	Intraoperative
Blood loss	We record the amount of blood loss (ml) based on the anesthesia record sheet.	From enrollment to the end of surgery at 1 year
Change in hemoglobin level	Record the difference in hemoglobin concentration before and after surgery (in g/L).	From enrollment to the end of surgery at 1 year
Hospital stay duration	The number of days from admission to discharge for the patient (days).	From enrollment to the end of surgery at 1 year
Number of patients with surgical complications	If patients experience discomfort during the perioperative period or after surgery, they will be advised to seek medical attention promptly to assess for complications. The severity of complications is evaluated using the Clavien-Dindo classification.	From enrollment to the end of surgery at 1 year

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse
• Other Study ID Numbers: 2024PHB374-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No