NCT01644409

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

July 17, 2012

Last Update Submit

July 18, 2012

Conditions

Overactive BladderUrinary Frequency or Urgency Adverse EventUrinary Incontinence, Urge

Keywords

OABOveractive bladderUrgencyIncontinence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud Unviversity Nijmegen Medical Centre

Nijmegen, Gelderland, 6500, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 22151641RESULT

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Dick Janssen, MD

    Radboud University Nijmegen Medical Centre Dept of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD researcher

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

July 1, 2012

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations

NL(1)