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A randomized controlled study of modified paravaginal repair combined with sacralspinous ligament suspension for the treatment of pelvic organ prolapse

A randomized controlled study of modified paravaginal repair combined with sacral spinous ligament suspension for the treatment of pelvic organ prolapse

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062902
Enrollment
Unknown
Registered
2022-08-23
Start date
2022-08-15
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Pelvic Organ Prolapse

Interventions

Research group:Modified paravaginal repair combined with sacralspinous ligament suspension
Control group:Sacral fixation

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with informed consent and will sign an informed consent form; 2. Adult female; 3. Patients with symptomatic pelvic prolapse and POP-Q stage II and above; 4. Patients with poor conservative treatment effect and willingness to operate; 5. Examination confirms paravaginal defects; 6. Patients who can be followed up for 1 year after surgery.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of pelvic radiotherapy; 2. Patients with a history of transvaginal mesh treatment of prolapse; 3. Patients with a history of transvaginal mesh exposure; 4. Women with fertility requirements; Patients during pregnancy or lactation; 5. Patients with pelvic pain caused by spasm of the pelvic floor muscles found on the basis of the examination; 6. Patients with plans to insert mesh in other places in addition to the top of the vagina for pop and other locations (insertion of slings for urinary incontinence is not a criterion for exclusion) 7. Patients with long-term steroid use with immune disorders; 8. Patients currently smoking; 9. Patients with pain syndromes that may lead to increased sensitivity to pelvic pain (e.g., fibromyalgia, bladder pain syndrome); 10. Patients with suspected malignancy; 11. Patients who are too old to tolerate surgery or whose surgical benefits are significantly less than surgical trauma.

Design outcomes

Primary

MeasureTime frame
Pelvic Organ Prolapse Quantification (POP-Q) System;

Secondary

MeasureTime frame
Pelvic Floor Distress Inventory-20;Pelvic Floor Impact Questionnaire-7;Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire-12;

Countries

China

Contacts

Public ContactHuang Shuai

Beijing Hospital

huangshuai4471@bjhmoh.cn+86 15110279466

Outcome results

None listed

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