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

NCT ID: NCT01644409

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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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

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Overactive Bladder Urinary Frequency or Urgency Adverse Event Urinary Incontinence, Urge

Keywords

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OAB Overactive bladder Urgency Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dick Janssen

MD researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dick Janssen, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Centre Dept of Urology

Locations

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Radboud Unviversity Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.x.

Reference Type RESULT
PMID: 22151641 (View on PubMed)

Other Identifiers

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USQ-9yr

Identifier Type: OTHER

Identifier Source: secondary_id

USQ-9yr

Identifier Type: -

Identifier Source: org_study_id