Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Intervention Model: Crossover Assignment
- Primary Purpose: Screening
- Masking: None (Open Label)
- Study Primary Completion Date: November 2010
Interventions
- Procedure: First stage tined lead procedure
- bilateral first stage tined lead placement
Arms, Groups and Cohorts
- Experimental: 1
- (Crossover study)
Clinical Trial Outcome Measures
Primary Measures
- 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
Secondary Measures
- Complete or incomplete urinary retention
- Time Frame: 3 weeks
Participating in This Clinical Trial
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 1. 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. 2. 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 Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Maastricht University Medical Center
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Philip van Kerrebroeck, Professor, Principal Investigator, Maastricht University Hospital
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