CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 272 enrolled
Drug / intervention
pelvic organ prolapse repairprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03098641
NCT03098641N/ACompleted

Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.

Groupe Hospitalier de la Rochelle Ré Aunis·observational·Posted Apr 4, 2017·Updated Nov 13, 2023

In Brief

An observational study evaluating pelvic organ prolapse repair for Pelvic Organ Prolapse. Completed, enrolled 272 participants across 16 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsColoplast A/S

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartMay 1, 2017
Primary CompletionSep 26, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.2 years ago

Interventions

pelvic organ prolapse repairprocedure

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