Sacral Neuromodulation & Urodynamics

Overactive Bladder Clinical Trial

Official title:

Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03614767
• Other study ID #: 17/30334
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2019
• Source: Universiteit Antwerpen
• Contact: Stefan De Wachter, MD PhD FEBU
• Phone: 8215934
• Email: stefan.dewachter[@]antwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Overactive bladder

• Non-obstructive urinary retention

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Non-obstructive Urinary Retention
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Retention

Intervention

Diagnostic Test:
• urodynamics
Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.

Locations

Country	Name	City	State
Belgium	University of antwerp	Antwerpen	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bladder volume	Change in bladder volume is measured before and after test procedure for sacral neuromodulation	3 weeks
Primary	Change in bladder sensation	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
Primary	Change in ice water test	Ice water is infused in the bladder and incontinence upon insertion of the ice water is assessed before and after sacral neuromodulation	3 weeks