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
Recruitment status was Recruiting
Sponsor:
Maastricht University Medical Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
- 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
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
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 May 23, 2013