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SCP vs HUSLS for Pelvic Organ Prolapse Repair

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ClinicalTrials.gov Identifier: NCT02800512
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sam Siddighi, MD, Loma Linda University

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : December 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: HUSLS



Primary Outcome Measures :
  1. Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 month post operative ]
    Subject will fill out the PFDI-7 questionnaire

  2. questionnaires PFDI-7 [ Time Frame: 12 month post operative ]
    Subject will fill out the PFDI-7 questionnaire

  3. questionnaires PFIQ-20 [ Time Frame: 6 month post operative ]
    Subject will fill out the PFIQ-20 questionnaire

  4. questionnaires PFIQ-20 [ Time Frame: 12 month post operative ]
    Subject will fill out the PFIQ-20 questionnaire

  5. questionnaires PISQ-12 [ Time Frame: 6 month post operative ]
    Subject will fill out the PISQ-12 questionnaire

  6. questionnaires PISQ-12 [ Time Frame: 12 month post operative ]
    Subject will fill out the PISQ-12 questionnaire

  7. questionnaires PGI-I [ Time Frame: 6 month post operative ]
    Subject will fill out the PGI-I

  8. questionnaires PGI-I [ Time Frame: 12 month post operative ]
    Subject will fill out the PGI-I



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800512


Contacts
Contact: Sam Siddighi, MD 9095582782 ssiddighi@llu.edu
Contact: Christine Cota 9095582595 ccota@llu.edu

Locations
United States, California
Loma Linda University URO/GYN Recruiting
Loma Linda, California, United States, 92354
Contact: Sam Siddighi    909-558-2782    ssiddighi@llu.edu   
Contact: Christine Cota    9095582595    ccota@llu.edu   
Principal Investigator: Sam Siddighi         
Sub-Investigator: Jeffery Hardesty         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Sam Siddighi Loma Linda University Health Care

Publications:
Responsible Party: Sam Siddighi, MD, Chief of FPMRS, Loma Linda University
ClinicalTrials.gov Identifier: NCT02800512     History of Changes
Other Study ID Numbers: 5160158
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sam Siddighi, MD, Loma Linda University:
pelvic organ prolapse
cystocele
rectocele
enterocele

Additional relevant MeSH terms:
Hernia
Prolapse
Pelvic Organ Prolapse
Cystocele
Rectocele
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases