N/A
Completed N=272
Smartmesh Technology in Pelvic Floor Repair Procedures
Source: ClinicalTrials.gov NCT03098641 ↗Enrolled (actual)
272
Serious AEs
5.1%
Results posted
Jun 2019
Primary outcomePrimary: Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding — 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding |
6 | — |
| SECONDARY Number of Patients With Early Complications |
43 | — |
| SECONDARY Number of Patients With Late Complications |
43 | — |
| SECONDARY Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery |
0; 1; 61; 169; 39; 78 | — |
| SECONDARY Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery |
128; 54; 24; 0; 1; 188 | — |
| SECONDARY Number of Patients With Preoperative Urinary Signs |
97; 103; 118; 48 | — |
| SECONDARY Number of Patients With Postoperative Urinary Signs |
48; 24; 13 | — |
| SECONDARY Number of Patients With Preoperative Digestive Signs |
21; 13 | — |
| SECONDARY Number of Patients With Postoperative Digestive Signs |
6; 3 | — |
| SECONDARY Number of Patients With Preoperative Active Sexuality |
94 | — |
| SECONDARY Number of Patients With Preoperative Dyspareunia |
16 | — |
| SECONDARY Number of Patients With Postoperative Active Sexuality |
41 | — |
| SECONDARY Number of Patients With Postoperative Dyspareunia |
3 | — |
| SECONDARY Preoperative Score at Numeric Pain Rating Scale |
7.3 | — |
| SECONDARY Postoperative Score at Numeric Pain Rating Scale |
0.46 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03098641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.