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
  Purpose

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 Intervention
Urinary Retention
Procedure: First stage tined lead procedure

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Maastricht University Medical Center:

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. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete or incomplete urinary retention [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
(Crossover study)
Procedure: First stage tined lead procedure
bilateral first stage tined lead placement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 7, 2009
Last Updated: September 17, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on August 28, 2014