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

Completed

• Conditions: Overactive Bladder; Urinary Frequency or Urgency Adverse Event; Urinary Incontinence, Urge

• Registration Number: NCT01644409
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-05
• Status Verified: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-18
• Last Update Submitted: 2012-07-18
• Study First Posted: 2012-07-19
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant in 2003-2004

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Exclusion Criteria

• Patient who had the implant removed before the first year after implantation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Radboud Unviversity Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands