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.
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 Type
OBSERVATIONAL
Enrollment
272
Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.
CH Dunkerque
Grande-Synthe, France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
Clinique Saint Ame
Lambres-lez-Douai, France
CH de Laon
Laon, France
Clinique Jules Verne
Nantes, France
CHU Nîmes
Nîmes, France
Hôpital des Diaconesses
Paris, France
Hôpital Kremlin-Bicêtre
Paris, France
CH de Cornouaille
Quimper, France
Clinique St Michel et St Anne
Quimper, France
...and 6 more locations
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
Perioperative morbidity
Time frame: up to 30 days after surgery
Number of Patients With Early Complications
Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: up to 4 years after surgery
Number of Patients With Preoperative Urinary Signs
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Time frame: within 4 weeks before surgery
Number of Patients With Postoperative Urinary Signs
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Time frame: up to 4 years after surgery
Number of Patients With Preoperative Digestive Signs
dyschezia, incontinence
Time frame: within 4 weeks before surgery
Number of Patients With Postoperative Digestive Signs
dyschezia, incontinence
Time frame: up to 4 years after surgery
Number of Patients With Preoperative Active Sexuality
Patients reporting active sexuality
Time frame: within 4 weeks before surgery
Number of Patients With Preoperative Dyspareunia
Patients reporting pain
Time frame: within 4 weeks before surgery
Number of Patients With Postoperative Active Sexuality
Patients reporting active sexuality
Time frame: up to 4 years after surgery
Number of Patients With Postoperative Dyspareunia
Patients reporting pain
Time frame: 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)
Time frame: 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)
Time frame: up to 48 hours after surgery
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