Overactive BladderNCT03194425
Standardization of Lead Placement for Sacral Neuromodulation. Part 1
A study testing Pelvic floor EMG in people with Overactive Bladder and Non Obstructive Urinary Retention, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
Retrospective case-control study. A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract dysfunction characteristics as the ones with good responses. 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?
- Pelvic floor EMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to Aug 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years and competent to provide consent
- Minimum 3 months of self-reported OAB symptoms or self-reported obstructive LUTS in addition to confirmed non-obstructive urinary retention on UDO
- Failed, or are not a candidate for more conservative treatment (i.e., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
- Willing to discontinue OAB medications for 2 weeks prior to the implant and for the entire study period
- Able to thoroughly fill in all questionnaires, voiding diaries and office visits for device programming and clinical evaluations before the TLP, 3 weeks after TLP and 6 weeks, 6 months and 1 year after implantation of definitive IPG.
Who cannot join
- Current of prior evidence of primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
- Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH)
- Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
- Unable to toilet self and have and maintain good personal hygiene
- Unable to provide clear, thoughtful responses to questions and questionnaires
Show all 20Show fewer
- Urinary tract, bladder or vaginal infection or inflammation
- Hematuria, and absence of an elaborate diagnostic work-up
- Severe or uncontrolled diabetes (A1C > 8, documented in the last 3 months) or diabetes with peripheral nerve involvement
- Allergy to local anesthetic or adhesives
- Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before the implant
- Pregnant, lactating, planning to become pregnant, given birth in the past 12 months, or female of child-bearing potential and not practicing a medically-approved method of birth control
- Skin lesions or compromised skin at the implant or stimulation site
- Use of investigational drug or device therapy or participation in any study involving or impacting gynecologic, urinary or renal function within past 4 weeks
- Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site
- Knowledge of planned MRIs, diathermy, or high output ultrasonic exposure
- Presence of a documented condition or abnormality that could compromise the safety of the patient
- Any psychiatric or personality disorder at the discretion of the study physician
- Interstitial cystitis or bladder pain syndrome as defined by the EAU guidelines
- Life expectancy of less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pelvic Floor EMG Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.
Retrospective case-control study.
A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract dysfunction characteristics as the ones with good responses. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events.
- Being tested
- Pelvic floor EMG
- Keywords
- Sacral neuromodulation, Electromyography, Pelvic floor
- 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.
Pelvic floor EMGDiagnostic test
Define pelvic floor EMG template measured by probe
| Study group | Role | What they receive |
|---|---|---|
| OAB | Experimental | Patients with overactive bladder on sacral neuromodulation. Receives: Diagnostic Test: Pelvic floor EMG |
| NOUR | Experimental | Patients with non-obstructive urinary retention on sacral neuromodulation. Receives: Diagnostic Test: Pelvic floor EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG activity of pelvic floor muscles in OAB patients and NOUR patients already on SNM
Latency and amplitude of pelvic floor measured by EMG probe
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Sep 2017
- Primary completionAug 2022 (estimated)
- Study completionAug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Donald Vaganée, Universiteit Antwerpen
- Investigators
- Stefan De Wachter, MD PhD FEBU, Study director, University Hospital, AntwerpDonald Vaganée, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194425
- Sponsor's protocol ID
- B300201523497 Part 1
- Status last verified
- Oct 2019
- First submitted
- 10 May 2017
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Pelvic Floor EMG Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.
- ClinicalTrials.gov ID
- NCT03194425
- Acronym / sponsor ID
- B300201523497 Part 1
- Keywords
- Sacral neuromodulation, Electromyography, Pelvic floor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 21 Jun 2017 (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.
Retrospective case-control study.
A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract dysfunction characteristics as the ones with good responses. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAB | Experimental | Diagnostic Test: Pelvic floor EMGPatients with overactive bladder on sacral neuromodulation. |
| NOUR | Experimental | Diagnostic Test: Pelvic floor EMGPatients with non-obstructive urinary retention on sacral neuromodulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥18 years and competent to provide consent
- Minimum 3 months of self-reported OAB symptoms or self-reported obstructive LUTS in addition to confirmed non-obstructive urinary retention on UDO
- Failed, or are not a candidate for more conservative treatment (i.e., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
- Willing to discontinue OAB medications for 2 weeks prior to the implant and for the entire study period
- Able to thoroughly fill in all questionnaires, voiding diaries and office visits for device programming and clinical evaluations before the TLP, 3 weeks after TLP and 6 weeks, 6 months and 1 year after implantation of definitive IPG.
Key exclusion criteria (20 listed)
- Current of prior evidence of primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
- Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH)
- Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
- Unable to toilet self and have and maintain good personal hygiene
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 |
|---|---|---|
| Pelvic floor EMGDefine pelvic floor EMG template measured by probe | Diagnostic test | NOUR, OAB |
Primary outcome
EMG activity of pelvic floor muscles in OAB patients and NOUR patients already on SNM
Time frame: 1 day
Latency and amplitude of pelvic floor measured by EMG probe
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: No
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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
Donald Vaganée principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor EMG in people with 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 5 inclusion and 20 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG activity of pelvic floor muscles in OAB patients and NOUR patients already on SNM (time frame: 1 day). 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.