Evaluation of pelvic floor repair system (A randomized controlled trial of a self-developed pelvic floor repair system vs. the Avaulta system for treatment of pelvic organ prolapse)

A randomized controlled trial of a self-developed pelvic floor repair system vs. the Avaulta system for treatment of pelvic organ prolapse

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200060158

Enrollment

Unknown

Registered

2022-05-20

Start date

2014-02-01

Completion date

Unknown

Last updated

2024-04-29

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:pelvic reconstructive surgery using the self-developed system

Control group:pelvic reconstructive surgery using the Avaulta system

Eligibility

Sex/Gender

Female

Age

35 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 35 to 85 years; 2. Pelvic organ prolapse greater than or equal to stage II and organ prolapse affect patients' daily life; 3. Patients with gynecological malignant tumor were excluded by preoperative examination; 4. Those who agree to participate in the test and can cooperate with the examination and treatment; 5. Patients who can communicate with researchers.

Exclusion criteria

Exclusion criteria: 1. Patients with acute infection stage; 2. Have relatively serious liver and kidney, heart, blood, nerve diseases, diabetes; 3. History of asthma or severe drug allergy; 4. Patients with severe allergies or connective tissue or immune diseases; 5. Patients with mental or mental illness; 6. Patients with drugs that affect coagulation function.

Design outcomes

Primary

Measure	Time frame
POP-Q stage and measurements;	—

Secondary

Measure	Time frame
Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7);Incontinence Quality of Life (I-QOL);Post-Treatment Satisfaction Scores;	—

Countries

China

Contacts

Public ContactTong Xiaowen

Shanghai Tongji Hospital (Tongji Hospital, Tongji University)

tongxiaowen2022@163.com+86 15921145182

Outcome results

None listed

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