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Urgent-SQ in Treatment of Overactive Bladder Syndrome: 9-yr Follow up

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01644409
Collaborator
(none)
8
Enrollment
1
Location
6
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Long term open label study on safety and durability of the Urgent-SQ tibial implant device for refractory overactive bladder syndrome (OAB).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a follow-up study of the study by van der Pal et al. (see reference). The Urgent-SQ is an ankle (tibail) implant that is used for on demand electical stimulation that stimulates the tibial nerve for the treatment of overactive bladder syndrome (OAB). The implant is placed via an minimal invasive surgical procedure. The implant can be activated with an external pulse generator.

    This study by van de Pal et al. was conducted with the approval of the local Medical Ethical Committee and with a one year systematic follow-up of eight patients. Since then, follow-up up and use of the device was open-label.

    This study reports on the long-term (9yrs) the safety and durability of the Urgent-SQ implant in these eight patients.

    Parameters evaluated were local pain and discomford at the site of the implant, AE's related to the implant or the use of the implant. Current use of the treatment and effectivity of the treatment.

    van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL.Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    May 1, 2012
    Actual Study Completion Date :
    Jul 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant in 2003-2004
      Exclusion Criteria:
      • Patient who had the implant removed before the first year after implantation.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Radboud Unviversity Nijmegen Medical Centre Nijmegen Gelderland Netherlands 6500

      Sponsors and Collaborators

      • Radboud University Medical Center

      Investigators

      • Principal Investigator: Dick Janssen, MD, Radboud University Nijmegen Medical Centre Dept of Urology

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Dick Janssen, MD researcher, Radboud University Medical Center
      ClinicalTrials.gov Identifier:
      NCT01644409
      Other Study ID Numbers:
      • USQ-9yr
      • USQ-9yr
      First Posted:
      Jul 19, 2012
      Last Update Posted:
      Jul 19, 2012
      Last Verified:
      Jul 1, 2012
      Keywords provided by Dick Janssen, MD researcher, Radboud University Medical Center
      OAB
      Overactive bladder
      Urgency
      Incontinence
      Additional relevant MeSH terms:
      Urinary Incontinence
      Urinary Bladder, Overactive
      Urinary Incontinence, Urge

      Study Results

      No Results Posted as of Jul 19, 2012