Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study

Tracking Information
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; (submitted: April 7, 2009)	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; (submitted: April 7, 2009)	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
Condition ICMJE	Urinary Retention
Intervention ICMJE	Procedure: First stage tined lead procedure; bilateral first stage tined lead placement
Study Arms	Experimental: 1; (Crossover study); Intervention: Procedure: First stage tined lead procedure
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: April 7, 2009)	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: Patients who signed the informed consent; Patients (male and female), aged between 18-70 years, with non obstructive urinary retention. Two specific subcategories of retention are included; Incomplete voiding or incomplete retention (>100 cc residual) such as hesitancy or intermittency, that are due to an acontractile detrusor or due to urethral sphincter overactivity. The overactivity of the sphincter may occur in absence of detrusor contraction and may be the cause of the lack of detrusor activity.; Complete retention. These individuals are completely unable to void. All patients must have the potential for storing an adequate volume of urine: i.e., at least 100 ml Exclusion Criteria: Known psychiatric disorders; Current or plans of pregnancy; Known neurologic diseases or impairment; including DM (severe or uncontrolled diabetes; or diabetes with peripheral nerve involvement), spinal cord injury, MS; Reiter's syndrome; Concomitant medical conditions that would limit the success of the procedure such as: active degenerative disc disease, spinal cord injury< 6 months old, bleeding complications, CVA< 6 months old etc.; Extra urethral incontinence; Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/ diagnosis.; Anatomic obstructive voiding disorders; Current urinary tract infection; Malignancy of urinary tract; Severe grade III/ IV pelvic prolapse, cystocele, urethrocele, enterocele; Proven interstitial cystitis or clinical symptoms of interstitial cystitis
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Philip van Kerrebroeck, Professor Maastricht University Hospital
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