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

NCT00878176 | Completed

• 1 other identifier: MEC 09-2-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

sacral neuromodulation therapy; urinary retention; screening; non obstructive urinary retention

Outcome Measures

Primary Outcomes (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.

  3 weeks

Secondary Outcomes (1)

• Complete or incomplete urinary retention

  3 weeks

Study Arms (1)

1

EXPERIMENTAL

(Crossover study)

Procedure: First stage tined lead procedure

Interventions

First stage tined lead procedure PROCEDURE

bilateral first stage tined lead placement

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

dept Urology, Maastricht University Hospital

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Philip van Kerrebroeck, Professor

  Maastricht University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 20, 2018

Record last verified: 2009-09

Locations

NL (1)