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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restorelle Direct Fix A | Anterior/Apical prolapse repair with Restorelle Direct Fix A |
| |
| Native Tissue Repair Anterior | Anterior/Apical prolapse repair with native tissue only |
| |
| Restorelle Direct Fix P | Posterior/Apical prolapse repair with Restorelle Direct Fix P |
| |
| Native Tissue Repair Posterior | Posterior/Apical prolapse repair with native tissue only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restorelle Direct Fix A | Device |
| ||
| Restorelle Direct Fix P |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional adverse events | 36 months | |
| Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7 | 36 months | |
| Subjects experiencing vaginal bulge |
Inclusion Criteria:
Exclusion Criteria:
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Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.
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| Name | Affiliation | Role |
|---|---|---|
| Jan-Paul Roovers, MD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sherry Thomas, M.D. | Agoura Hills | California | 91301 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40581283 | Derived | Sokol ER, Cosson M, Harris-Hicks JE, Mangel J, Thomas SL, Roovers JW. A Multicenter Prospective Study of Posterior Transvaginal Mesh Compared to Native Tissue Repair for Pelvic Organ Prolapse: 36 Month Outcomes. J Minim Invasive Gynecol. 2025 Oct;32(10):921-928. doi: 10.1016/j.jmig.2025.06.016. Epub 2025 Jun 26. |
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| Device |
|
| Native Tissue Repair Anterior | Procedure |
|
| Native Tissue Repair Posterior | Procedure |
|
| 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 |
| 36 months |
| Rates of revision and/or re-surgery | 36 months |
| Stanford |
| California |
| 94305 |
| United States |
| SurgOne Pelvic Solutions Center | Denver | Colorado | 80218 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Center for Urogynecology and Pelvic Surgery, Christiana Care Health System | Newark | Delaware | 19713 | United States |
| MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery | Washington D.C. | District of Columbia | 20010 | United States |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | United States |
| Andrew Shapiro | Owings Mills | Maryland | 21117 | United States |
| Baystate Health System | Springfield | Massachusetts | 01199 | United States |
| Female Pelvic Medicine & Urogynecology Institute of MI | Grand Rapids | Michigan | 49503 | United States |
| Beyer Research | Kalamazoo | Michigan | 49009 | United States |
| Adult & Pediatric Urology, PC | Omaha | Nebraska | 68114 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Atlantic Health System | Morristown | New Jersey | 07960 | United States |
| Premier Medical Group of Hudson Valley, PC | Poughkeepsie | New York | 12601 | United States |
| Montefiore Medical Research Center | The Bronx | New York | 10461 | United States |
| Novant Health Urogynecology | Charlotte | North Carolina | 28210 | United States |
| Women's Pelvic Health and Continence Center | Hamlet | North Carolina | 28345 | United States |
| Novant Health Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Akron Urogynecology Associates | Akron | Ohio | 44333 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | 18103 | United States |
| Center for Women's Health of Lansdale | Lansdale | Pennsylvania | 19446 | United States |
| The Female Pelvic Health Center | Newtown | Pennsylvania | 18940 | United States |
| Wellspan Urogynecology and Pelvic Reconstructive Surgery | York | Pennsylvania | 17403 | United States |
| Sanford Research | Sioux Falls | South Dakota | 57104 | United States |
| Swan Urogynecology | Nashville | Tennessee | 37203 | United States |
| Central Texas Urogynecology and Continence Center | Austin | Texas | 78758 | United States |
| Scott D. Lauer, DO, PA | Colleyville | Texas | 76034 | United States |
| Carilion Clinic New River Valley | Christiansburg | Virginia | 24073 | United States |
| The Group for Women | Norfolk | Virginia | 23502 | United States |
| Integrity Medical Research | Mountlake Terrace | Washington | 98042 | United States |
| Centre for Advanced Reproductive Endosurgery | St Leonards | New South Wales | 2065 | Australia |
| Mater Pelvic Health | Pimlico | Queensland | 4812 | Australia |
| UZ Leuven | Leuven | 3000 | Belgium |
| Kingston General Hospital | Kingston | Ontario | K7L 2VT | Canada |
| Hôpital Maisonneuve-Rosemount | Montreal | Quebec | H1T 2M4 | Canada |
| CHUS-CRC | Sherbrooke | Quebec | J1H 5N4 | Canada |
| CHRU Lille | Lille | 59037 | France |
| CHU Nimes | Nîmes | 30029 | France |
| Bergman Clinics | Amsterdam | 1081 | Netherlands |
| AMC Medical Center | Amsterdam | 1105 | Netherlands |
| Bergman Clinics | Bilthoven | 3723 MB | Netherlands |
| Amphia Hospital | Breda | 4819 EV | Netherlands |
| Spaarne Gasthuis | Haarlem | 2035 RC | Netherlands |
| Maastricht UMC | Maastricht | 6229 HX | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| ISALA | Zwolle | 8025 AB | Netherlands |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D059952 | Pelvic Floor Disorders |
| D012735 | Sexual Dysfunction, Physiological |
| D014596 | Uterine Prolapse |
| D052858 | Cystocele |
| D020047 | Rectocele |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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