Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
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ClinicalTrials.gov Identifier: NCT00878176 |
Recruitment Status
: Unknown
Verified September 2009 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted
: April 8, 2009
Last Update Posted
: September 18, 2009
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Sponsor:
Maastricht University Medical Center
Information provided by:
Maastricht University Medical Center
Tracking Information | ||||
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First Submitted Date ICMJE | April 7, 2009 | |||
First Posted Date ICMJE | April 8, 2009 | |||
Last Update Posted Date | September 18, 2009 | |||
Study Start Date ICMJE | June 2009 | |||
Estimated Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The primary endpoint is the eligibility for SNM therapy. This is defined as yes or no. A patient is eligible for the therapy when he or she can void again or the volume increased with at least 50%, and the catheterized volume is less then 100ml. [ Time Frame: 3 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00878176 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Complete or incomplete urinary retention [ Time Frame: 3 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study | |||
Official Title ICMJE | Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study | |||
Brief Summary | The objective of this study is to determine whether bilateral sacral nerve stimulation with First stage tined lead placement test is more effective than unilateral stimulation, among patients with non obstructive urinary retention. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Screening |
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Condition ICMJE | Urinary Retention | |||
Intervention ICMJE | Procedure: First stage tined lead procedure
bilateral first stage tined lead placement |
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Study Arms | Experimental: 1
(Crossover study)
Intervention: Procedure: First stage tined lead procedure |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | December 2010 | |||
Estimated Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Two specific subcategories of retention are included
All patients must have the potential for storing an adequate volume of urine: i.e., at least 100 ml Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00878176 | |||
Other Study ID Numbers ICMJE | MEC 09-2-005 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Prof. P. van Kerrebroeck, Maastricht University Medical Center | |||
Study Sponsor ICMJE | Maastricht University Medical Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Maastricht University Medical Center | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |