SCP vs HUSLS for Pelvic Organ Prolapse Repair

• Sponsor: Loma Linda University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02800512
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 68
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse; Cystocele; Rectocele; Enterocele	Procedure: Robotic sacrocolpopexy; Procedure: high uterosacral ligament suspension	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial
• Actual Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sacrocolpopexy Robotic sacrocolpopexy	Procedure: Robotic sacrocolpopexy; 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.; Other Names: R-SCP
Active Comparator: HUSLS Vaginal high uterosacral ligament suspension	Procedure: high uterosacral ligament suspension; 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.; Other Names: HUSLS

Outcome Measures

Primary Outcome Measures

1. Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively [3 month post operative]

   Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

2. Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively [6 month post operative]

   Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

3. Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively [12 month post operative]

   Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

Secondary Outcome Measures

1. questionnaires PFDI-7 [6 month post operative]

   Subject will fill out the PFDI-7 questionnaire

2. questionnaires PFDI-7 [12 month post operative]

   Subject will fill out the PFDI-7 questionnaire

3. questionnaires PFIQ-20 [6 month post operative]

   Subject will fill out the PFIQ-20 questionnaire

4. questionnaires PFIQ-20 [12 month post operative]

   Subject will fill out the PFIQ-20 questionnaire

5. questionnaires PISQ-12 [6 month post operative]

   Subject will fill out the PISQ-12 questionnaire

6. questionnaires PISQ-12 [12 month post operative]

   Subject will fill out the PISQ-12 questionnaire

7. questionnaires PGI-I [6 month post operative]

   Subject will fill out the PGI-I

8. questionnaires PGI-I [12 month post operative]

   Subject will fill out the PGI-I

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 Years of age or older

• Signed Informed Consent

• Symptomatic pelvic organ prolapse,

• Willing and able to complete all study visit

Exclusion Criteria:

• Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery),

• Dementia or considered unable to complete questionnaires

1. Hx of Alzheimer Disease

2. Hx multiple strokes or other neurologic condition

3. Caregiver states the subject is unable to complete

4. MDs opinion

• Inability to complete follow up visits due to transportation issues

1. No access to transportation (ie. does not have vehicle)

2. Live > 2 hours from LLUH

3. Does not have financial means

• Congenital anomalies

1. Bladder Exstrophy

2. Connective tissue disease

3. Neovaginal prolapse

4. Prolapse of sex change vagina

• Chronic pelvic pain

1. 6 months of pelvic pain of undetermined origin

2. not cyclic pain (eg. period pain or dysmenorrhea)

3. Patient has comorbidities of CPP

4. Fibromyalgia

5. Interstitial cystitis

6. Vulvodynia

• Contraindications to Mesh,

1. Opposition to the use mesh (ie. due to religious beliefs)

2. History of mesh complications in past

• Pregnant or planning to become pregnant during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University URO/GYN	Loma Linda	California	United States	92354

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: Sam Siddighi, Loma Linda University Health Care

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT02800512
• Other Study ID Numbers: 5160158
• First Posted: Jun 15, 2016
• Last Update Posted: Sep 20, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Loma Linda University: pelvic organ prolapse; cystocele; rectocele; enterocele
• Additional relevant MeSH terms: Rectocele; Cystocele; Prolapse; Pelvic Organ Prolapse; Hernia

Study Results

No Results Posted as of Sep 20, 2021