Smartmesh Technology in Pelvic Floor Repair Procedures

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT03098641
• Lead Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-04
• Study Start: 2017-05-01
• Primary Completion: 2017-09-26
• Study Completion: 2017-09-26
• Results First Submitted: 2018-01-23
• Results First Submitted QC: 2019-02-18
• Results First Posted: 2019-06-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 272

Inclusion Criteria

• Over 18
• woman 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
• informed and not opposed to the use of her data

Exclusion Criteria

• Opposed to the use of her data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding	up to 30 days after surgery	Perioperative morbidity

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Preoperative Active Sexuality	within 4 weeks before surgery	Patients reporting active sexuality
Number of Patients With Preoperative Dyspareunia	within 4 weeks before surgery	Patients reporting pain
Number of Patients With Postoperative Dyspareunia	up to 4 years after surgery	Patients reporting pain
Number of Patients With Postoperative Digestive Signs	up to 4 years after surgery	dyschezia, incontinence
Number of Patients With Postoperative Urinary Signs	up to 4 years after surgery	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Number of Patients With Late Complications	up to 4 years after surgery	self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other
Number of Patients With Postoperative Active Sexuality	up to 4 years after surgery	Patients reporting active sexuality
Postoperative Score at Numeric Pain Rating Scale	up to 48 hours after surgery	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Number of Patients With Preoperative Digestive Signs	within 4 weeks before surgery	dyschezia, incontinence
Number of Patients With Early Complications	up to 30 days after surgery	Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery	preoperative, within 48 hours before surgery	Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery	up to 4 years after surgery	Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
Number of Patients With Preoperative Urinary Signs	within 4 weeks before surgery	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Preoperative Score at Numeric Pain Rating Scale	Within 48 hours before surgery	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)

Trial Locations

Locations (16)

CH Dunkerque; 🇫🇷 Grande Synthe, France

Clinique Jules Verne; 🇫🇷 Nantes, France

CH de Cornouaille; 🇫🇷 Quimper, France

CHU Nîmes; 🇫🇷 Nimes, France

CH de Laon; 🇫🇷 Laon, France

Groupe Hospitalier de la Rochelle Ré Aunis; 🇫🇷 La Rochelle, France

Clinique Saint Ame; 🇫🇷 Lambres-lez-Douai, France

Hôpital des Diaconesses; 🇫🇷 Paris, France

Hôpital Kremlin-Bicêtre; 🇫🇷 Paris, France

Polyclinique de Courlancy; 🇫🇷 Reims, France

Clinique St Michel et St Anne; 🇫🇷 Quimper, France

Clinique la Sagesse; 🇫🇷 Rennes, France

Hôpital Foch; 🇫🇷 Suresnes, France

Agyl; 🇫🇷 Strasbourg, France

CH Robert Pax; 🇫🇷 Sarreguemines, France

Hôpitaux du Léman; 🇫🇷 Thonon les Bains, France