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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

April 7, 2009
September 17, 2009
June 2009
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00878176 on ClinicalTrials.gov Archive Site
Complete or incomplete urinary retention [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
Urinary Retention
Procedure: First stage tined lead procedure
bilateral first stage tined lead placement
Experimental: 1
(Crossover study)
Intervention: Procedure: First stage tined lead procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Randall Leong, MD +31433875255 r.leong@mumc.nl
Contact: Stefan De Wachter, MD, PhD +3143387258 s.dewachter@mumc.nl
Netherlands
 
NCT00878176
MEC 09-2-005
No
Prof. P. van Kerrebroeck, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Philip van Kerrebroeck, Professor Maastricht University Hospital
Maastricht University Medical Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP