Overactive Bladder, Non Obstructive Urinary RetentionNCT03614754
Sacral Neuromodulation and Pudendal Somatic Afferents
An observational study of Overactive Bladder, Non Obstructive Urinary Retention, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. 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?
- Somatosensory evoked potentials
- How many people
- 40 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: Urological patients with overactive bladder or non-obstructive urinary retention.
Who may be able to join
- Overactive bladder
- Non-obstructive urinary retention
Who cannot join
- Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Stefan De Wachter, MD PhD FEABU
About this study
Official title: The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve
Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is.
This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.
- Being tested
- Somatosensory evoked potentials
- 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.
Somatosensory evoked potentialsDiagnostic test
Stimulation of the pudendal nerve while recording at the sensory cortex.
| Study group | Role | What they receive |
|---|---|---|
| Successes | Patients with reduction of symptoms >50% during the test procedure for sacral neuromodulation. Receives: Diagnostic Test: Somatosensory evoked potentials | |
| Failures | Patients with reduction of symptoms <50% during the test procedure for sacral neuromodulation. Receives: Diagnostic Test: Somatosensory evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency change
Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.
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 Bladder, Non Obstructive Urinary RetentionStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Vaganée, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614754
- Sponsor's protocol ID
- 17/30/334
- 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
- The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve
- ClinicalTrials.gov ID
- NCT03614754
- Acronym / sponsor ID
- 17/30/334
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 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.
Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is.
This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successes | – | Diagnostic Test: Somatosensory evoked potentialsPatients with reduction of symptoms >50% during the test procedure for sacral neuromodulation. |
| Failures | – | Diagnostic Test: Somatosensory evoked potentialsPatients with reduction of symptoms <50% during the test procedure for sacral neuromodulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Urological patients with overactive bladder or non-obstructive urinary retention.
Key inclusion criteria (2 listed)
- Overactive bladder
- Non-obstructive urinary retention
Key exclusion criteria (1 listed)
- Neurogenic disorders (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 |
|---|---|---|
| Somatosensory evoked potentialsStimulation of the pudendal nerve while recording at the sensory cortex. | Diagnostic test | Failures, Successes |
Primary outcome
Latency change
Time frame: 3 weeks
Latency of somatosensory evoked potential are recorded before and after test procedure sacral neuromodulation expressed in milliseconds.
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, Non Obstructive Urinary Retention
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
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.
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, 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 Donald A Vaganee, MD PhD student (8213047 ext. 323, donald.vaganee@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency change (time frame: 3 weeks). 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; AzTrials last refreshed its copy on 30 Oct 2026.