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Clinical Trials/NCT03614767
NCT03614767UnknownNot Applicable

Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients

Universiteit Antwerpen1 site in 1 country100 target enrollmentStarted: August 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Change in bladder sensation

Study 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Donald Vaganée

Principal Investigator

Universiteit Antwerpen

Study Sites (1)

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