Prolapse
Conditions
Interventions
GYNECARE PROLIFT.
Sponsors
Ethicon_Johnson & Johnson Medical Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently. 2. Age >
Exclusion criteria
Exclusion criteria: 1. Additional surgical intervention for POP repair concurrent to the Gynecare Prolift +M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrophy in a non-Gynecare Prolift+M treated compartment). 2. Previous repair of pelvic organ prolapse involving insertion of mesh. 3. Previous hysterectomy within 6 months of scheduled surgery. 4. Experimental drug or experimental medical device within 3 months prior to the planned procedure. 5. Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared. 6. Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery. 7. History of chemotherapy or pelvic radiation therapy. 8. Systemic disease known to affect bladder or bowel function (e.g. Parkinson*s disease, multiple sclerosis, spina bifida, spinal cord injury or trauma). 9. Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvadynia). 10. Nursing or pregnant or intends future pregnancy. 11. In the investigator*s opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There will be one primary effectiveness end-point: * POP-Q score at 12 months post-procedure. Success will be determined by achievement of a POP-Q score of ICS Stage *1, without further surgical re-intervention for POP. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Summary of ICS Stages at 3 and 36 month visits. * Summary of treated compartment ICS POP-Q stage at 3, 12 and 36 months. * Proportion of subjects with the leading edge within the hymen (i.e. all POP-Q values to be less than 0) and without further re-intervention for POP at 12 and 36 months. * Mean scores and change from baseline in PFDI-20 scores at 3, 12 and 36 month visits including sub scores (POPDI, CRADI and UDI). * Proportion of subjects with a change from baseline * 45 points in the PFDI-20 summary score at 12 and 36 months. * Mean scores and change from baseline in PFIQ-7 at 3, 12 and 36 month visits including sub-scores (POPIQ, CRAIQ and UIQ). * Proportion of subjects with a change from baseline * 36 points in the PFIQ-7 summary score at 12 and 36 months. * Days to return to normal activities (walking, driving, work, household activities and sexual intercourse). * EuroQol (EQ-5D health state) mean change from baseline at 3 and 12 months visit (overall using the EQ-5D index score, and also for each individual item). * In subjects sexually active at baseline, assessment of sexual function using PISQ-12 assessed at 12 and 36 month visits (mean scores and change from baseline). * Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia * Incidence of mesh contraction, as determined by pain on palpation of mesh during pelvic examination at 3, 12 and 36 months. * Incidence of vaginal wall stiffness, as determined by the investigator on physical examination at 3, 12 and 36 months. * Total time in the operating room. * Length of procedure (from time of first incision to time of last suture). * Nights in hospital (from date of admission to date of discharge; based on actual data and *readiness for discharge*). * Pain score 24 hours post surgery and at the 1 month visit, measured using Visual Analog Scale (VAS). * Subject global impression assessed on a 5 point Likert scale at 3, 12 and 36-month visi | — |
Countries
Netherlands
Outcome results
None listed