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Safety and Efficacy Study of Regen Sling to Treatment SUI

NCT02106299 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2014-04-08

No results posted yet for this study

Summary

To evaluate the treatment safety and efficacy of Regen Sling developed by medprin Regenerative Medical Technologies Co., Ltd. for female patients with stress urinary incontinence

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Regen sling

Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a Regen sling (medprin).

DEVICE

tension-free vaginal tape-obturator(TVT-O)

Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (gynecare™, USA).

Sponsors & Collaborators

  • Medprin Regenerative Medical Technologies Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhu Lan, professor · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

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 NCT02106299 on ClinicalTrials.gov