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N/A N=272

Smartmesh Technology in Pelvic Floor Repair Procedures

Pelvic Organ Prolapse

Enrolled (actual)
272
Serious AEs
5.1%
Results posted
Jun 2019
Primary outcome: Primary: Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding — 6 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
pelvic organ prolapse repair (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Primary completion
Sep 2017

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

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