Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 (Crossover study) |
Procedure: First stage tined lead procedure
bilateral first stage tined lead placement
|
Outcome Measures
Primary Outcome 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. [3 weeks]
Secondary Outcome Measures
- Complete or incomplete urinary retention [3 weeks]
Eligibility Criteria
Criteria
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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | dept Urology, Maastricht University Hospital | Maastricht | Netherlands | 6202 AZ |
Sponsors and Collaborators
- Maastricht University Medical Center
Investigators
- Principal Investigator: Philip van Kerrebroeck, Professor, Maastricht University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MEC 09-2-005