Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation
Primary Purpose
Overactive Bladder, Non Obstructive Urinary Retention
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Filling out voiding diaries.
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Non obstructive urinary retention, Sacral neuromodulation
Eligibility Criteria
Inclusion Criteria:
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients should have been diagnosed with overactive bladder syndrome and should be put on the waiting list for scheduling treatment with sacral neuromodulation.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- patients receiving neurological or psychiatric medication without being diagnosed with a neurological or psychiatric disease
- patients who have been treated by means of bladder wall botulin toxin injections in the previous year
- patients with evident subsequent complaints of bladder pain syndrome or other pelvic pain
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation by voiding diaries
Arm Description
Outcomes
Primary Outcome Measures
Time of onset of effect of treatment with sacral neuromodulation
Secondary Outcome Measures
Full Information
NCT ID
NCT02040519
First Posted
January 13, 2014
Last Updated
April 4, 2017
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02040519
Brief Title
Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation
Official Title
Time of Onset and Time of Offset of Sacral Neuromodulation Effect - "Wash in - Wash Out"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
February 6, 2017 (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
Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to conservative treatment. Success rates range from 70 to 80%, and good long-term results are reported. The working mechanism of SNM is not completely understood, and the only prognostic factor for good response to this treatment is a successful test stimulation period. There is no consensus on the duration of this test stimulation period. The experience in our clinic during test stimulation period is that for responders it takes up to one week to achieve maximal effect, after the system is turned 'on'. On the other hand the investigators notice that after turning the neuromodulation system 'off', it will take a few hours for symptoms to return to the baseline situation. The fact is: no information concerning the so called "time of onset" and "time of offset" (or popular called: wash-in / wash-out) of sacral neuromodulation is available in current literature.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Non Obstructive Urinary Retention
Keywords
Overactive bladder, Non obstructive urinary retention, Sacral neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluation by voiding diaries
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Filling out voiding diaries.
Primary Outcome Measure Information:
Title
Time of onset of effect of treatment with sacral neuromodulation
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients should have been diagnosed with overactive bladder syndrome and should be put on the waiting list for scheduling treatment with sacral neuromodulation.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
patients receiving neurological or psychiatric medication without being diagnosed with a neurological or psychiatric disease
patients who have been treated by means of bladder wall botulin toxin injections in the previous year
patients with evident subsequent complaints of bladder pain syndrome or other pelvic pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. A. van Koeveringe, urologist
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202AZ
Country
Netherlands
12. IPD Sharing Statement
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Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation
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