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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Retention

Intervention / Treatment
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* Procedure: First stage tined lead procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>(Crossover study) | Procedure: First stage tined lead procedure<br>* bilateral first stage tined lead placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete or incomplete urinary retention |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacral neuromodulation therapy, urinary retention, screening, non obstructive urinary retention