Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
NCT ID: NCT00878176
Last Updated: 2018-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2009-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CROSSOVER
SCREENING
NONE
Study Groups
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1
(Crossover study)
First stage tined lead procedure
bilateral first stage tined lead placement
Interventions
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First stage tined lead procedure
bilateral first stage tined lead placement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Philip van Kerrebroeck, Professor
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Hospital
Locations
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dept Urology, Maastricht University Hospital
Maastricht, , Netherlands
Countries
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Other Identifiers
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MEC 09-2-005
Identifier Type: -
Identifier Source: org_study_id
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