Sacral Neuromodulation & Urodynamics

NCT03614767 | Unknown

• 1 other identifier: 17/30334
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder; Non-obstructive Urinary Retention

Outcome Measures

Primary Outcomes (3)

• Change in bladder volume

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

  3 weeks

• 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

• 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

Study Arms (2)

Successes

Patients with \>50% improvement during test procedure of sacral neuromodulation.

Diagnostic Test: urodynamics

Failures

Patients with \<50% improvement during test procedure of sacral neuromodulation.

Diagnostic Test: urodynamics

Interventions

urodynamics DIAGNOSTIC_TEST

Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.

Also known as: Ice water test, Slider

Failures; Successes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with overactive bladder or non-obstructive urinary retention.

You may qualify if:

• Overactive bladder
• Non-obstructive urinary retention

You may not qualify if:

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

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

University of antwerp

Antwerp, Edegem, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Stefan De Wachter, MD PhD FEBU

  University Hospital, Antwerp

  STUDY DIRECTOR

Central Study Contacts

Stefan De Wachter, MD PhD FEBU

CONTACT

8215934; stefan.dewachter@antwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: August 1, 2017
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

BE (1)