Comparing two surgical methods for treating 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 testing two different surgical methods for treating pelvic organ prolapse in patients who haven't found relief from other treatments to see which one works better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06903988 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, non-blinded, randomized controlled trial aimed at evaluating the efficacy and safety of two surgical techniques for patients with Stage III or higher pelvic organ prolapse who have not responded to conservative treatment. A total of 86 patients will be randomly assigned to either the laparoscopic lateral suspension group or the transvaginal sacrospinous ligament fixation group in a 1:1 ratio. Follow-up assessments will occur at 1 month, 3 months, 6 months, and 1 year post-surgery, with the primary outcome being the surgical success rate at one year. The study aims to determine if the laparoscopic approach is not inferior to the transvaginal method.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with Stage III or higher pelvic organ prolapse who have not benefited from conservative treatments.
Not a fit: Patients who have previously undergone surgery for pelvic organ prolapse or those with a history of anti-incontinence surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective surgical options for pelvic organ prolapse, potentially improving their quality of life.
How similar studies have performed: Other studies have explored similar surgical techniques, but the specific comparison of these two methods in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shiyan Wang
- Email: 1810301256@pku.edu.cn
- Phone: +8613834964768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.