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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878176
• Other study ID #: MEC 09-2-005
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Procedure:
• First stage tined lead procedure
bilateral first stage tined lead placement

Locations

Country	Name	City	State
Netherlands	dept Urology, Maastricht University Hospital	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete or incomplete urinary retention		3 weeks