N/A
Completed N=30
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
Pelvic Organ Prolapse (POP)
Source: ClinicalTrials.gov NCT01378065 ↗
Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Oct 2015
Primary outcomePrimary: Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) — 30; 0; 0; 0 participants
Summary
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) |
30; 0; 0; 0; 30; 0 | — |
| PRIMARY Palpability of the Restorelle Direct Fix A&P |
29; 1; 0; 0; 26; 3 | — |
| SECONDARY Rates of de Novo Dyspareunia |
9.1 | — |
| SECONDARY Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks |
100 | — |
| SECONDARY Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months |
100 | — |
| SECONDARY Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months |
96.3 | — |
| SECONDARY Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months |
100 | — |
| SECONDARY Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months. |
3.3; 0.0 | — |
| SECONDARY Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit |
100 | — |
| SECONDARY Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit |
100 | — |
| SECONDARY Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit |
100 | — |
| SECONDARY Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit |
100 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. |
15; 10; 1; 1; 0; 2 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. |
14; 9; 2; 3; 1; 0 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. |
12; 7; 6; 2; 1; 1 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. |
18; 4; 4; 3; 1; 0 | — |
| SECONDARY Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks |
45.1; 25.7 | <.001 sig |
| SECONDARY Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months |
45.1; 17.1 | <.001 sig |
| SECONDARY Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months |
45.1; 16.4 | <.001 sig |
| SECONDARY Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months |
45.1; 18.1 | <.001 sig |
| SECONDARY Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks |
15.7; 14.7 | 0.202 |
| SECONDARY Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months |
12.2; 15.7 | 0.001 sig |
| SECONDARY Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months |
12.8; 15.7 | 0.004 sig |
| SECONDARY Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months |
12.8; 15.7 | 0.034 sig |
| SECONDARY Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit |
24.9; 15.7 | 0.001 sig |
| SECONDARY Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit |
24.9; 15.3 | 0.004 sig |
| SECONDARY Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit |
24.9; 14.1 | <.001 sig |
| SECONDARY Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit |
24.9; 10.8 | <.001 sig |
Eligibility Criteria
Inclusion Criteria
- Adult female at least 18 years of age
- Willing and able to provide written informed consent
- Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical intervention in the anterior and/or posterior compartment
- Willing and able to complete all follow-up visits and procedures indicated in the protocol
Exclusion Criteria
- Concurrent surgical treatment of pelvic organ prolapse using anything other than the Restorelle Direct Fix A&P
- Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure
- Previous pelvic organ prolapse repair using synthetic grafts
- Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction
- Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction
- Pregnant or a desire to become pregnant
- Previous radiation or other treatments for cancer in the pelvic area
- Immunosuppression and/or current systemic steroid user
- On any anticoagulation therapy at the time of implant or with bleeding diathesis
Data sourced from ClinicalTrials.gov (NCT01378065). 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.