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

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

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Frequency or Urgency Adverse Event Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud Unviversity Nijmegen Medical Centre

Nijmegen, Gelderland, 6500, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jul 19, 2012
Registry last updated: Jul 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed