Soft Tissue Graft for Repair of Pelvic Organ Prolapse

Study Overview
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Brief Summary
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The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft (Study Product) for the repair of pelvic organ prolapse in women.

Official Title
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A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Surgisis® Soft Tissue Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse. POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse) At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia) Exclusion Criteria: Age < 18 years BMI > 40 Not medically fit for transvaginal surgery under general or spinal anesthesia Active UTI at the time of the index procedure as determined by urine culture Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.) Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer Currently planned obliterative surgical repair for pelvic organ prolapse Systemic infection at the time of surgery Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents Pregnant, breastfeeding or planning pregnancy during the study period Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos) Physical allergies or cultural objections to the receipt of porcine products Life expectancy of less than 12 months Ongoing participation in an investigational device or drug trial Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome) Active vaginal infection at the time of the index procedure History of pelvic inflammatory disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgisis® Soft Tissue Graft<br> | Device: Surgisis® Soft Tissue Graft<br>* Surgisis® Soft Tissue Graft for pelvic organ prolapse repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence of pelvic organ prolapse |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, Graft repair