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Prospective clinical study of pelvic floor stress SHEN classification and three-dimensional pelvic floor reconstruction surgery for female pelvic floor dysfunction

Prospective clinical study of pelvic floor stress SHEN classification and three-dimensional pelvic floor reconstruction surgery for female pelvic floor dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060393
Enrollment
Unknown
Registered
2022-05-30
Start date
2022-05-19
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

pelvic floor dysfunction

Interventions

Group 1:Trans-obturator vaginal tape
Group 2:Trans-obturator vaginal tape + posterior basin vagina shaping
Group 3:Anterior basin mesh + posterior basin vagina shaping
Group 4:Cervical amputation
Group 5:Cervical amputation + Mid-urethral Suspension
Group 6:Cervical amputation + Anterior basin mesh + posterior basin vagina shaping
Group 7:Transvaginal sacrospinous ligament suspension or sacrum suspension

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 69 Years

Inclusion criteria

Inclusion criteria: Cases of stress incontinence were enrolled according to the 1990 ICS definition of incontinence. The diagnosis of pelvic organ prolapse in 2001 the National Institutes of Health about the definition of pelvic organ prolapse: any front segmental vagina or cervix reach or exceed the hymen margin more than 1 cm, the equivalent of ICS above about POP - Q phase I and phase.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Mental nervous system disease or mental retardation; 3. Poor physical condition, unable to tolerate surgery after cardiopulmonary function assessment; 4. Combined with obvious surgical contraindications or advanced malignant tumors; 5. History of pelvic floor surgery; 6. History of pelvic floor deformities; 7. Intrauterine contraceptive ring; 8. Pacemaker placement; 9. Age < 18 years old; 10. Suffering from a history of claustrophobia.

Design outcomes

Primary

MeasureTime frame
Pelvic organ prolapse quantitive examination, POP-Q;—

Secondary

MeasureTime frame
Demographic data;Pelvic floor distress inventory short form 20;Pelvic floor impact questionnaire short form 7;Perioperative parameters;Vaginal impression model;Magnetic resonance imaging;Four-dimensional ultrasonography;Complication;Exposure/erosion of mesh;Patient Global Impression of Change;Urodynamic study;—

Countries

China

Contacts

Public ContactJihong Shen

The First Affiliated Hospital of Kunming Medical University

kmsjh99@aliyun.com+86 13577009705

Outcome results

None listed

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