Overactive BladderNCT03614767
Sacral Neuromodulation & Urodynamics
An observational study of Overactive Bladder and Non-obstructive Urinary Retention, run by Universiteit Antwerpen at 1 site in Belgium.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Non-obstructive Urinary Retention
- What is being tested?
- urodynamics
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2017to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient with overactive bladder or non-obstructive urinary retention.
Who may be able to join
- Overactive bladder
- Non-obstructive urinary retention
Who cannot join
- Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of antwerp
Antwerp, Edegem, 2650
Stefan De Wachter, MD PhD FEBU
About this study
Official title: 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
- Being tested
- urodynamics
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urodynamicsDiagnostic test
Also called Ice water test, Slider
Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.
| Study group | Role | What they receive |
|---|---|---|
| Successes | Patients with >50% improvement during test procedure of sacral neuromodulation. Receives: Diagnostic Test: urodynamics | |
| Failures | Patients with <50% improvement during test procedure of sacral neuromodulation. Receives: Diagnostic Test: urodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bladder volume
Change in bladder volume is measured before and after test procedure for sacral neuromodulation
Measured: 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
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Aug 2017
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Vaganée, Universiteit Antwerpen
- Investigators
- Stefan De Wachter, MD PhD FEBU, Study director, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614767
- Sponsor's protocol ID
- 17/30334
- Status last verified
- Oct 2019
- First submitted
- 30 Jul 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients
- ClinicalTrials.gov ID
- NCT03614767
- Acronym / sponsor ID
- 17/30334
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successes | – | Diagnostic Test: urodynamicsPatients with >50% improvement during test procedure of sacral neuromodulation. |
| Failures | – | Diagnostic Test: urodynamicsPatients with <50% improvement during test procedure of sacral neuromodulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with overactive bladder or non-obstructive urinary retention.
Key inclusion criteria (2 listed)
- Overactive bladder
- Non-obstructive urinary retention
Key exclusion criteria (1 listed)
- Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urodynamicsAlso: Ice water test, SliderBladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum. | Diagnostic test | Failures, Successes |
Primary outcome
Change in bladder volume
Time frame: 3 weeks
Change in bladder volume is measured before and after test procedure for sacral neuromodulation
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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Overactive Bladder
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan De Wachter, MD PhD FEBU study director
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Non-obstructive Urinary Retention, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan De Wachter, MD PhD FEBU (8215934 ext. 323, stefan.dewachter@antwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bladder volume (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.