search
Back to results

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

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
First stage tined lead procedure
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Urinary Retention focused on measuring sacral neuromodulation therapy, urinary retention, screening, non obstructive urinary retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • dept Urology, Maastricht University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

(Crossover study)

Outcomes

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.

Secondary Outcome Measures

Complete or incomplete urinary retention

Full Information

First Posted
April 7, 2009
Last Updated
July 18, 2018
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00878176
Brief Title
Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
Official Title
Sacral Neuromodulation Test With Bilateral First Stage Tined Lead Procedure in Patients With Non-obstructive Urinary Retention: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
sacral neuromodulation therapy, urinary retention, screening, non obstructive urinary retention

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
(Crossover study)
Intervention Type
Procedure
Intervention Name(s)
First stage tined lead procedure
Intervention Description
bilateral first stage tined lead placement
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Complete or incomplete urinary retention
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip van Kerrebroeck, Professor
Organizational Affiliation
Maastricht University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
dept Urology, Maastricht University Hospital
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs