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Clinical Trials/NCT03614767
NCT03614767
Unknown
N/A

Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients

Universiteit Antwerpen1 site in 1 country100 target enrollmentAugust 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
Universiteit Antwerpen
Enrollment
100
Locations
1
Primary Endpoint
Change in bladder sensation
Last Updated
6 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
July 31, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Donald Vaganée

Principal Investigator

Universiteit Antwerpen

Eligibility Criteria

Inclusion Criteria

  • Overactive bladder
  • Non-obstructive urinary retention

Exclusion Criteria

  • Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)

Outcomes

Primary Outcomes

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

Change in bladder volume

Time Frame: 3 weeks

Change in bladder volume is measured before and after test procedure for sacral neuromodulation

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

Study Sites (1)

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