RCT for Transvaginal Self-cut Mesh vs Mesh-kit for Severe POP
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pelvic Organ Prolapse
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: participant and investigator are not blinded. outcome assessor who are in charge of follow-up assement is masked.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 53 years and 75 years
- Gender
- Only males
Description
The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of life, complications and costs. Analysis will be performed according to the intention to treat princip...
The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of life, complications and costs. Analysis will be performed according to the intention to treat principle. Based on comparable success rate of 90% and 10% as the margin(beta 0.2 and one sided alpha 0.025), about 312 patients in total from 11 centers will be recruited per group including 10% drop-out. The aims of the research are to demonstrate whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research might influence the treatment selection for POP in China.
Tracking Information
- NCT #
- NCT03849157
- Collaborators
- Shanghai Medstron Medical Co.Ltd
- Chinese Academy of Medical Sciences
- LinkDoc Technology (Beijing) Co. Ltd.
- Investigators
- Principal Investigator: Lan Zhu Peking Union Medical College Hospital
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