Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Study Overview
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Brief Summary
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The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.

Official Title
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Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Restorelle Direct Fix A
* Device: Restorelle Direct Fix P
* Procedure: Native Tissue Repair Anterior
* Procedure: Native Tissue Repair Posterior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female at least 18 years of age Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of somewhat, moderately or quite a bit) Subject is willing to provide written informed consent Subject is willing and able to comply with the follow-up regimen Exclusion Criteria: Subject is pregnant or intends to become pregnant during the study Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical) Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months) Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica) Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis Subject has uncontrolled diabetes mellitus (DM) Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit) Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis) Subject is not able to conform to the modified dorsal lithotomy position Subject is currently participating in or plans to participate in another device or drug study during this study Subject has a known sensitivity to polypropylene Subject has had previous prolapse repair with mesh in the target compartment(s) Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue repair

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Restorelle Direct Fix A<br>Anterior/Apical prolapse repair with Restorelle Direct Fix A | Device: Restorelle Direct Fix A<br> <br> |
| Native Tissue Repair Anterior<br>Anterior/Apical prolapse repair with native tissue only | Procedure: Native Tissue Repair Anterior<br> <br> |
| Restorelle Direct Fix P<br>Posterior/Apical prolapse repair with Restorelle Direct Fix P | Device: Restorelle Direct Fix P<br> <br> |
| Native Tissue Repair Posterior<br>Posterior/Apical prolapse repair with native tissue only | Procedure: Native Tissue Repair Posterior<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Prolapse | Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging. | 12 Month | 
| Rate of device and procedure related serious adverse events |  | 12 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Prolapse | Recurrent prolapse is measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging. | 12 Month | 
| Recurrence of Prolapse | Recurrent Prolapse is measured anatomically by leading edge of prolapse in the target compartment beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging. | 36 Month | 
| Recurrence of Prolapse | Recurrent Prolapse measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging. | 36 Month | 
| Device or Procedure related AEs of interest |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Dysfunction, Mesh, POP, Anterior, Posterior, Apical, Uterine Prolapse, Cystocele, Rectocele, Enterocele, Vaginal Vault Prolapse, Native Tissue Repair, Repair Augmented with Mesh, Pathological Conditions, Anatomical, Restorelle Direct Fix, Vaginal Mesh, Transvaginal Mesh, Pelvic Floor Disorder, Pelvic Organ Prolapse, Transvaginal