SCP vs HUSLS for Pelvic Organ Prolapse Repair
Primary Purpose
Pelvic Organ Prolapse, Cystocele, Rectocele
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic sacrocolpopexy
high uterosacral ligament suspension
Sponsored by
About this trial
This is an interventional basic science trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, cystocele, rectocele, enterocele
Eligibility Criteria
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
- Hx of Alzheimer Disease
- Hx multiple strokes or other neurologic condition
- Caregiver states the subject is unable to complete
- MDs opinion
Inability to complete follow up visits due to transportation issues
- No access to transportation (ie. does not have vehicle)
- Live > 2 hours from LLUH
- Does not have financial means
Congenital anomalies
- Bladder Exstrophy
- Connective tissue disease
- Neovaginal prolapse
- Prolapse of sex change vagina
Chronic pelvic pain
- > 6 months of pelvic pain of undetermined origin
- not cyclic pain (eg. period pain or dysmenorrhea)
- Patient has comorbidities of CPP
- Fibromyalgia
- Interstitial cystitis
- Vulvodynia
Contraindications to Mesh,
- Opposition to the use mesh (ie. due to religious beliefs)
- History of mesh complications in past
- Pregnant or planning to become pregnant during the study period.
Sites / Locations
- Loma Linda University URO/GYNRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sacrocolpopexy
HUSLS
Arm Description
Robotic sacrocolpopexy
Vaginal high uterosacral ligament suspension
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
questionnaires PFDI-7
Subject will fill out the PFDI-7 questionnaire
questionnaires PFDI-7
Subject will fill out the PFDI-7 questionnaire
questionnaires PFIQ-20
Subject will fill out the PFIQ-20 questionnaire
questionnaires PFIQ-20
Subject will fill out the PFIQ-20 questionnaire
questionnaires PISQ-12
Subject will fill out the PISQ-12 questionnaire
questionnaires PISQ-12
Subject will fill out the PISQ-12 questionnaire
questionnaires PGI-I
Subject will fill out the PGI-I
questionnaires PGI-I
Subject will fill out the PGI-I
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02800512
Brief Title
SCP vs HUSLS for Pelvic Organ Prolapse Repair
Official Title
Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Cystocele, Rectocele, Enterocele
Keywords
pelvic organ prolapse, cystocele, rectocele, enterocele
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacrocolpopexy
Arm Type
Active Comparator
Arm Description
Robotic sacrocolpopexy
Arm Title
HUSLS
Arm Type
Active Comparator
Arm Description
Vaginal high uterosacral ligament suspension
Intervention Type
Procedure
Intervention Name(s)
Robotic sacrocolpopexy
Other Intervention Name(s)
R-SCP
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
high uterosacral ligament suspension
Other Intervention Name(s)
HUSLS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Description
Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.
Time Frame
3 month post operative
Title
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Description
Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.
Time Frame
6 month post operative
Title
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Description
Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.
Time Frame
12 month post operative
Secondary Outcome Measure Information:
Title
questionnaires PFDI-7
Description
Subject will fill out the PFDI-7 questionnaire
Time Frame
6 month post operative
Title
questionnaires PFDI-7
Description
Subject will fill out the PFDI-7 questionnaire
Time Frame
12 month post operative
Title
questionnaires PFIQ-20
Description
Subject will fill out the PFIQ-20 questionnaire
Time Frame
6 month post operative
Title
questionnaires PFIQ-20
Description
Subject will fill out the PFIQ-20 questionnaire
Time Frame
12 month post operative
Title
questionnaires PISQ-12
Description
Subject will fill out the PISQ-12 questionnaire
Time Frame
6 month post operative
Title
questionnaires PISQ-12
Description
Subject will fill out the PISQ-12 questionnaire
Time Frame
12 month post operative
Title
questionnaires PGI-I
Description
Subject will fill out the PGI-I
Time Frame
6 month post operative
Title
questionnaires PGI-I
Description
Subject will fill out the PGI-I
Time Frame
12 month post operative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Hx of Alzheimer Disease
Hx multiple strokes or other neurologic condition
Caregiver states the subject is unable to complete
MDs opinion
Inability to complete follow up visits due to transportation issues
No access to transportation (ie. does not have vehicle)
Live > 2 hours from LLUH
Does not have financial means
Congenital anomalies
Bladder Exstrophy
Connective tissue disease
Neovaginal prolapse
Prolapse of sex change vagina
Chronic pelvic pain
> 6 months of pelvic pain of undetermined origin
not cyclic pain (eg. period pain or dysmenorrhea)
Patient has comorbidities of CPP
Fibromyalgia
Interstitial cystitis
Vulvodynia
Contraindications to Mesh,
Opposition to the use mesh (ie. due to religious beliefs)
History of mesh complications in past
Pregnant or planning to become pregnant during the study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam Siddighi, MD
Phone
9095582782
Email
ssiddighi@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Cota
Phone
9095582595
Email
ccota@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Siddighi
Organizational Affiliation
Loma Linda University Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University URO/GYN
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Siddighi
Phone
909-558-2782
Email
ssiddighi@llu.edu
First Name & Middle Initial & Last Name & Degree
Christine Cota
Phone
9095582595
Email
ccota@llu.edu
First Name & Middle Initial & Last Name & Degree
Sam Siddighi
First Name & Middle Initial & Last Name & Degree
Jeffery Hardesty
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16813916
Citation
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.
Results Reference
background
PubMed Identifier
20113690
Citation
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.
Results Reference
background
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SCP vs HUSLS for Pelvic Organ Prolapse Repair
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