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Clinical study on the efficacy and safety of autologous hamstring tendon in pelvic floor reconstruction surgery

Clinical study on the efficacy and safety of autologous hamstring tendon in pelvic floor reconstruction surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073571
Enrollment
Unknown
Registered
2023-07-14
Start date
2021-05-18
Completion date
Unknown
Last updated
2023-07-16

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 floor reconstruction with autologous tendon

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Women over 50 years old; (2) Patients with primary pelvic organ prolapse; (3) The main prolapse edge of vagina = POP-Q 2 stage or the protrusion of anterior and posterior vaginal wall = POP-Q 2 stage; (4) Vaginal prolapse symptoms, affecting the quality of life, requiring surgical treatment.

Exclusion criteria

Exclusion criteria: (1) Long term immunosuppressive therapy, including glucocorticoids or cytotoxic drugs; (2) Previously diagnosed as collagen disease (i.e. Marfan syndrome, congenital connective tissue dysplasia syndrome) (3) Hamstring tendon related exclusion criteria (4) Do not accept surgery or refuse to sign informed consent for any reason

Design outcomes

Primary

MeasureTime frame
anatomic improvement before and after operation;symptom improvement before and after operation;

Secondary

MeasureTime frame
quality of life improvement;tendon recovery;

Countries

China

Contacts

Public ContactZhang Kun

Peking University Third Hospital

bysyzk@163.com+86 156 1190 8327

Outcome results

None listed

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