- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614767
Sacral Neuromodulation & Urodynamics
October 13, 2019 updated by: Donald Vaganée, Universiteit Antwerpen
Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients
In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR).
Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stefan De Wachter, MD PhD FEBU
- Phone Number: 323 8215934
- Email: stefan.dewachter@antwerpen.be
Study Locations
-
-
Edegem
-
Antwerpen, Edegem, Belgium, 2650
- Recruiting
- University of Antwerp
-
Contact:
- Stefan De Wachter, MD PhD FEBU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with overactive bladder or non-obstructive urinary retention.
Description
Inclusion Criteria:
- Overactive bladder
- Non-obstructive urinary retention
Exclusion Criteria:
- Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Successes
Patients with >50% improvement during test procedure of sacral neuromodulation.
|
Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.
Other Names:
|
Failures
Patients with <50% improvement during test procedure of sacral neuromodulation.
|
Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bladder volume
Time Frame: 3 weeks
|
Change in bladder volume is measured before and after test procedure for sacral neuromodulation
|
3 weeks
|
Change in bladder sensation
Time Frame: 3 weeks
|
Bladder sensation is measured by a slider (indicating bladder fullness scaled from 0 to 100) before and after test procedure for sacral neuromodulation
|
3 weeks
|
Change in ice water test
Time Frame: 3 weeks
|
Ice water is infused in the bladder and incontinence upon insertion of the ice water is assessed before and after sacral neuromodulation
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stefan De Wachter, MD PhD FEBU, University Hospital, Antwerp
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2017
Primary Completion (ANTICIPATED)
July 31, 2022
Study Completion (ANTICIPATED)
July 31, 2022
Study Registration Dates
First Submitted
July 30, 2018
First Submitted That Met QC Criteria
July 30, 2018
First Posted (ACTUAL)
August 3, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 15, 2019
Last Update Submitted That Met QC Criteria
October 13, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/30334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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