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Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

Sponsor
Atlantic Health System (Other)
Overall Status
Completed
CT.gov ID
NCT01982188
Collaborator
(none)
104
Enrollment
1
Location
15
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy
    Study Start Date :
    Sep 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Single incision sling

    Outcome Measures

    Primary Outcome Measures

    1. Cough Stress Test [12 months post procedure]

      Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.

    Secondary Outcome Measures

    1. mesh related complications [12 months post procedure]

      possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period

    2. Urinary Distress Inventory 6 (UDI-6) [baseline and 12 months postoperatively]

      This validated questionnaires will be given to subject to collect subjective data

    3. Urinary Impact Questionnaire (UIQ-7) [baseline and 12 months postoperatively]

      this validated questionnaire will be completed by subject to collect subjective data

    4. Sandvick Severity Index Questionnaire [baseline and 12 months postoperatively]

      This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period
    Exclusion Criteria:
    • previous surgical treatment for stress urinary incontinence (SUI)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atlantic Health System Morristown New Jersey United States 07960

    Sponsors and Collaborators

    • Atlantic Health System

    Investigators

    • Principal Investigator: Charbel Salamon, MD, Atlantic Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    charbel salamon, Principal Investigator, Atlantic Health System
    ClinicalTrials.gov Identifier:
    NCT01982188
    Other Study ID Numbers:
    • R12-09-001
    First Posted:
    Nov 13, 2013
    Last Update Posted:
    Aug 11, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by charbel salamon, Principal Investigator, Atlantic Health System
    single incision sling
    cough stress test
    MiniArc
    UDI-6
    UIQ-7
    Sandvick Severity Index (SSI)
    Additional relevant MeSH terms:
    Urinary Incontinence
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Aug 11, 2016