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RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP

NCT03849157 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2019-02-21

No results posted yet for this study

Summary

Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective .

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

pelvic floor reconstructive surgery

transvaginal mesh implantation for pelvic organ prolapse

Sponsors & Collaborators

  • Shanghai Medstron Medical Co.Ltd

    collaborator UNKNOWN

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • LinkDoc Technology (Beijing) Co. Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Lan Zhu · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
53 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2020-01-12
Completion
2022-01-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849157 on ClinicalTrials.gov