search
Back to results

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
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

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

First Posted
April 26, 2016
Last Updated
May 25, 2023
Sponsor
Loma Linda University
search

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

Learn more about this trial

SCP vs HUSLS for Pelvic Organ Prolapse Repair

We'll reach out to this number within 24 hrs