Trials / Completed
CompletedNCT01644409
Urgent-SQ in Treatment of Overactive Bladder Syndrome: 9-yr Follow up
Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 8 (actual)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2012-05-01
- Completion
- 2012-07-01
- First posted
- 2012-07-19
- Last updated
- 2012-07-19
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01644409. Inclusion in this directory is not an endorsement.