Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse
Lead Sponsor:
Peking University People's Hospital
Conditions:
Pelvic Organ Prolapse (POP)
Eligibility:
FEMALE
18+ years
Phase:
NA
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 conserva...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Patients who, after evaluation by the surgeon, have other conditions that affect eligibility for inclusion.
Key Trial Info
Start Date :
April 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06903988
Start Date
April 5 2025
End Date
August 31 2026
Last Update
November 24 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100044