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

N/AActive Not RecruitingNCT06903988

Peking University People's Hospital86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pelvic Organ Prolapse (POP)

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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."

Time frame: From enrollment to the end of surgery at 1 year

Secondary Outcomes

Incidence of urinary retention after catheter removal

A residual urine volume greater than 100 ml as measured by ultrasound is considered urinary retention.

Time frame: 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.