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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Maastricht University Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT00878176

First received: April 7, 2009

Last updated: September 17, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 7, 2009

Last Updated Date

September 17, 2009

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening

Condition ^ICMJE

Urinary Retention

Intervention ^ICMJE

Procedure: First stage tined lead procedure

bilateral first stage tined lead placement

Study Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated 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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Randall Leong, MD	+31433875255	r.leong@mumc.nl
Contact: Stefan De Wachter, MD, PhD	+3143387258	s.dewachter@mumc.nl

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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