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

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

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:
  • Ice water test
  • Slider
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:
  • Ice water test
  • Slider

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.

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

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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