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Clinical Trials/NCT02800512
NCT02800512
Active, not recruiting
Not Applicable

Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial

Loma Linda University1 site in 1 country112 target enrollmentDecember 2016
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ConditionsPelvic Organ ProlapseCystoceleRectoceleEnterocele

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Loma Linda University
Enrollment
112
Locations
1
Primary Endpoint
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • questionnaires PISQ-12(12 month post operative)
  • questionnaires PFIQ-20(12 month post operative)
  • questionnaires PGI-I(12 month post operative)
  • questionnaires PFDI-7(12 month post operative)

Study Sites (1)

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