NCT03098641

Smartmesh Technology in Pelvic Floor Repair Procedures

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 272 (actual)
• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pelvic Organ Prolapse

Interventions

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

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-09-26
• Completion: 2017-09-26
• First posted: 2017-04-04
• Last updated: 2023-11-13
• Results posted: 2019-06-03

Locations

16 sites across 1 country: France