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Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology

Sponsor
Helios Medical Center Schleswig (Other)
Overall Status
Unknown status
CT.gov ID
NCT03640364
Collaborator
(none)
250
Enrollment
1
Location
38
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence.

    Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Multicenter Prospective Non-randomised Trial of Bilateral Sacrospinous Colposuspension (BSC) in the Treatment of Female Genital Prolapse Accompanied by Urinary Urge Symptomatology
    Actual Study Start Date :
    Apr 1, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2020
    Anticipated Study Completion Date :
    Jun 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination [Checked after 6 weeks, six months and twelve months]

      The change in symptoms after the surgical intervention is evaluated by clinical examination . The clinical examination is descriptive, not quantitative and no units are applicable or reportable.

    2. Change in score of standardized ICIQ documentation [Checked after 6 weeks, six months and twelve months]

      The International Consultation on Incontinence Questionnaire is used to evaluate Change in Quality of life and urge symptomatology

    Secondary Outcome Measures

    1. Anatomical correction of female pelvic organ prolapse [Checked after 6 weeks, six months and twelve months]

      Clinical examination of pelvic floor anatomy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • urge urinary incontinence or symptoms thereof

    • 18 years old or older

    • Compliance regarding data collection, therapy and follow-up

    • written informed consent

    • simultaneous performance of surgical colporrhaphy permitted

    Exclusion Criteria:

    • pelvic organ prolapse without symptoms of urinary urge

    • age less than 18 years

    • no informed consent

    • lack of compliance

    • adverse reaction to polypropylene

    • life expectancy less than anticipated duration of protocol

    • ASA 4

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Helios Medical Center Schleswig Germany 24837

    Sponsors and Collaborators

    • Helios Medical Center Schleswig

    Investigators

    • Principal Investigator: Dirk G Kieback, MD,Ph.D, Helios Medical Center Schleswig

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dirk G. Kieback, M.D., Ph.D, Head, Dept. of Obstetrics and Gynecology, Helios Medical Center Schleswig
    ClinicalTrials.gov Identifier:
    NCT03640364
    Other Study ID Numbers:
    • HCR051631
    First Posted:
    Aug 21, 2018
    Last Update Posted:
    Aug 21, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dirk G. Kieback, M.D., Ph.D, Head, Dept. of Obstetrics and Gynecology, Helios Medical Center Schleswig
    pelvic organ prolapse
    incontinence
    minimally invasive
    vaginal surgery
    macroporous
    lightweight
    mesh
    polypropylene
    POP
    urge
    Additional relevant MeSH terms:
    Urinary Incontinence, Urge
    Prolapse

    Study Results

    No Results Posted as of Aug 21, 2018