MedTrace Logo

Smartmesh Technology in Pelvic Floor Repair Procedures

NCT03098641 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2023-11-13

Study results available
· View outcomes & findings →

Summary

Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

pelvic organ prolapse repair

Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.

Sponsors & Collaborators

  • Coloplast A/S

    collaborator INDUSTRY

  • Groupe Hospitalier de la Rochelle Ré Aunis

    lead OTHER

Principal Investigators

  • Philippe Ferry, MD · Groupe Hospitalier de la Rochelle Ré Aunis

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2017-09-26
Completion
2017-09-26

Countries

  • France

Study Locations

More Related Trials

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 NCT03098641 on ClinicalTrials.gov