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Terminated by IRB
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The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.
To compare the effectiveness of Robotic Sacrocolpopexy versus vaginal High Uterosacral Ligament Suspension for treatment of pelvic organ prolapse. Both surgeries are standard of care and are equally and widely used throughout the country with well known safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacrocolpopexy | Active Comparator | Robotic sacrocolpopexy |
|
| HUSLS | Active Comparator | Vaginal high uterosacral ligament suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic sacrocolpopexy | Procedure | Sacrocolpopexy is a procedure to surgically correct vaginal vault prolapse where mesh is used to hold the vagina in the correct anatomical position. Robotic assistance is a minimally invasive method to perform this abdominal procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively | Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System. | 3 month post operative |
| Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively | Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System. | 6 month post operative |
| Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively | Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System. | 12 month post operative |
| Measure | Description | Time Frame |
|---|---|---|
| questionnaires PFDI-7 | Subject will fill out the PFDI-7 questionnaire | 6 month post operative |
| questionnaires PFDI-7 | Subject will fill out the PFDI-7 questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery),
Dementia or considered unable to complete questionnaires
Inability to complete follow up visits due to transportation issues
Congenital anomalies
Chronic pelvic pain
Contraindications to Mesh,
Pregnant or planning to become pregnant during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Sam Siddighi | Loma Linda University Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University URO/GYN | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16813916 | Background | Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol. 2006 Aug;176(2):655-9. doi: 10.1016/j.juro.2006.03.040. | |
| 20113690 | Background | Margulies RU, Rogers MA, Morgan DM. Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Feb;202(2):124-34. doi: 10.1016/j.ajog.2009.07.052. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D052858 | Cystocele |
| D020047 | Rectocele |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
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|
| high uterosacral ligament suspension | Procedure | Utilizing uterosacral ligaments to support the vaginal cuff can be performed vaginally-by passing sutures bilaterally through the uterosacral ligaments. near the level of the ischial spine. HUSLS is a vaginal minimally invasive procedure for POP. |
|
|
| 12 month post operative |
| questionnaires PFIQ-20 | Subject will fill out the PFIQ-20 questionnaire | 6 month post operative |
| questionnaires PFIQ-20 | Subject will fill out the PFIQ-20 questionnaire | 12 month post operative |
| questionnaires PISQ-12 | Subject will fill out the PISQ-12 questionnaire | 6 month post operative |
| questionnaires PISQ-12 | Subject will fill out the PISQ-12 questionnaire | 12 month post operative |
| questionnaires PGI-I | Subject will fill out the PGI-I | 6 month post operative |
| questionnaires PGI-I | Subject will fill out the PGI-I | 12 month post operative |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |