Smartmesh Technology in Pelvic Floor Repair Procedures

Status Completed

Clinical Trial 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.

Clinical Trial Description

Between January 2013 and December 2016, in the participating centers, all adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis are eligible. Collected data are about the peri-operative period and the data available at the last consultation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03098641
Study type	Observational
Source	Groupe Hospitalier de la Rochelle Ré Aunis
Contact
Status	Completed
Phase
Start date	May 1, 2017
Completion date	September 26, 2017

View Details

See also
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Smartmesh Technology in Pelvic Floor Repair Procedures — Restorelle

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms