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

July 18, 2012 updated by: Dick Janssen, Radboud University Medical Center

Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500
        • Radboud Unviversity Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (Estimate)

July 19, 2012

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USQ-9yr (Other Identifier: Radboud University Nijmegen Medical Centre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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