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Comparison of Transvaginal Uterine Sling versus Laparoscopic Sacrocolpopexy in Efficacy and Safety for Severe Uterine Prolapse: A Prospective, Multicenter, Randomized, Parallel-Controlled, Non-Inferiority Trial

Comparison of Transvaginal Uterine Sling versus Laparoscopic Sacrocolpopexy in Efficacy and Safety for Severe Uterine Prolapse: A Prospective, Multicenter, Randomized, Parallel-Controlled, Non-Inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103202
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic organ prolapse

Interventions

Experimental group:Transvaginal Uterine Sling
Control group:Laparoscopic Sacrocolpopexy

Sponsors

Department of Urology, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age > = 65 years old female; 2. According to the POP-Q score, those with uterine prolapse of grade 3 or above; 3. Voluntarily participate in this pilot study and sign the informed consent form; 4. All follow-up patients who are willing to comply with study guidance and complete the requirements.

Exclusion criteria

Exclusion criteria: 1. Patients with total or partial uterine resection; 2. Patients who have undergone previous uterine prolapse surgery; 3. Those who need or wish to have their uterus removed; 4. There are contraindications to uterine preservation (if clinically suggested, Pap smear and/or Pielle endometrial biopsy screening is required); 5. Those who cannot tolerate general anesthesia surgery or laparoscopic surgery; 6. Patients with weak abdominal wall; 7. Those who have known bleeding disorders, or who have received or plan to receive anticoagulants, antiplatelets, thrombolytics, non-steroidal anti-inflammatory drugs or other drugs known to increase the coagulation time within 14 days before signing the informed consent; 8. Those who cannot be treated with lithotomy surgery (such as those who cannot be treated with lithotomy after hip arthroplasty).

Design outcomes

Primary

MeasureTime frame
Composite failure rate;

Secondary

MeasureTime frame
Composite success rate;The Pelvic Floor Distress Inventory Questionnaire-20;Pelvic Floor Impact Questionnaire – Short Form 7;Euroqol 5D;Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised;Visual Analogue Scale/Score;Patient Global Impression of Improvement;operation time;Intraoperative bleeding;Length of hospital stay;

Countries

China

Contacts

Public ContactDeyi Luo

Department of Urology, West China Hospital, Sichuan University

luodeyi1985@163.com+86 189 8060 6809

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026