Smartmesh Technology in Pelvic Floor Repair Procedures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: pelvic organ prolapse repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pelvic organ prolapse repair|Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding | Perioperative morbidity | up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Early Complications | Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery | up to 30 days after surgery | 
| Number of Patients With Late Complications | self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other | up to 4 years after surgery | 
| Pelvic Organ Prolapse Quantification (POP-Q) Exam 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) | preoperative, within 48 hours before surgery | 
| Pelvic Organ Prolapse Quantification (POP-Q) Exam 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) | up to 4 years after surgery | 
| Number of Patients With Preoperative Urinary Signs | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence | within 4 weeks before surgery | 
| Number of Patients With Postoperative Urinary Signs | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence | up to 4 years after surgery | 
| Number of Patients With Preoperative Digestive Signs | dyschezia, incontinence | within 4 weeks before surgery | 
| Number of Patients With Postoperative Digestive Signs | dyschezia, incontinence | up to 4 years after surgery | 
| Number of Patients With Preoperative Active Sexuality | Patients reporting active sexuality | within 4 weeks before surgery | 
| Number of Patients With Preoperative Dyspareunia | Patients reporting pain | within 4 weeks before surgery | 
| Number of Patients With Postoperative Active Sexuality | Patients reporting active sexuality | up to 4 years after surgery | 
| Number of Patients With Postoperative Dyspareunia | Patients reporting pain | up to 4 years after surgery | 
| Preoperative Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | Within 48 hours before surgery | 
| Postoperative Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | up to 48 hours after surgery |