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

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ClinicalTrials.gov Identifier: NCT00878176
Recruitment Status : Unknown
Verified September 2009 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : April 8, 2009
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Maastricht University Medical Center

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
Urinary Retention Procedure: First stage tined lead procedure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
Study Start Date : June 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1
(Crossover study)
Procedure: First stage tined lead procedure
bilateral first stage tined lead placement




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Complete or incomplete urinary retention [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878176


Contacts
Contact: Randall Leong, MD +31433875255 r.leong@mumc.nl
Contact: Stefan De Wachter, MD, PhD +3143387258 s.dewachter@mumc.nl

Locations
Netherlands
dept Urology, Maastricht University Hospital Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Randall Leong, MD    +31433875255    r.leong@mumc.nl   
Principal Investigator: Philip van Kerrebroeck, Prof, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Philip van Kerrebroeck, Professor Maastricht University Hospital

Responsible Party: Prof. P. van Kerrebroeck, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00878176     History of Changes
Other Study ID Numbers: MEC 09-2-005
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Maastricht University Medical Center:
sacral neuromodulation therapy
urinary retention
screening
non obstructive urinary retention

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases