Overactive BladderNCT03199443
Standardization of Lead Placement for Sacral Neuromodulation Part 2
An observational study of Overactive Bladder and Non Obstructive Urinary Retention, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
Prospective observational 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 (LUT) dysfunction characteristics as the good responders. 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?
- EMG pelvic floor
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2017to Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with OAB (wet and dry) or non obstructive urinary retention who are therapy resistant to pelvic floor physiotherapy and medical management and wish to undergo a tined lead procedure.
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 lower urinary tract symptoms (LUTS) in addition to confirmed non-obstructive urinary retention on urodynamics.
- 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 magnetic resonance imaging (MRI), 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 guidelines of the European Association of Urology (EAU).
- Life expectancy of less than 1 year
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 FEBU, +3238215934, stefan.dewachter@uantwerpen.be
Donald Vaganée, +3238213047, donald.vaganee@uantwerpen.be
About this study
Official title: Pelvic Floor Electromyography Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.
Prospective observational 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 (LUT) dysfunction characteristics as the good responders. 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
- EMG pelvic floor
- 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.
EMG pelvic floorDiagnostic test
EMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| Overactive bladder patients | Not described Receives: Diagnostic Test: EMG pelvic floor | |
| Non Obstructive Urinary Retention patients | Not described Receives: Diagnostic Test: EMG pelvic floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG pelvic floor
Latency and amplitude measured by probe
Measured: 1 day
Secondary outcomes (3)
Prevalence of adverse events
Prevalence of adverse events, which are defined as: pain, decrease in efficacy and number of reprogramming sessions.
Measured: 2 years
Voiding diary
Determine the success rate of tined lead test period based upon changes in 3 days.
Measured: 1 year
Validated questionnaires (KHQ and PeLFis)
Determine the success rate of tined lead test period based upon changes in validated questionnaires (KHQ and PeLFis).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Oct 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- NCT03199443
- Sponsor's protocol ID
- B300201523497 Part 2
- 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 Electromyography Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.
- ClinicalTrials.gov ID
- NCT03199443
- Acronym / sponsor ID
- B300201523497 Part 2
- Keywords
- Sacral neuromodulation, Electromyography, Pelvic floor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 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.
Prospective observational 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 (LUT) dysfunction characteristics as the good responders. 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overactive bladder patients | – | Diagnostic Test: EMG pelvic floor |
| Non Obstructive Urinary Retention patients | – | Diagnostic Test: EMG pelvic floor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with OAB (wet and dry) or non obstructive urinary retention who are therapy resistant to pelvic floor physiotherapy and medical management and wish to undergo a tined lead procedure.
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 lower urinary tract symptoms (LUTS) in addition to confirmed non-obstructive urinary retention on urodynamics.
- 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 |
|---|---|---|
| EMG pelvic floorEMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated | Diagnostic test | Non Obstructive Urinary Retention patients, Overactive bladder patients |
Primary outcome
EMG pelvic floor
Time frame: 1 day
Latency and amplitude measured by probe
3 secondary outcomes
Prevalence of adverse events
Time frame: 2 years
Voiding diary
Time frame: 1 year
Validated questionnaires (KHQ and PeLFis)
Time frame: 1 year
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?
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 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?
Contact Stefan De Wachter, MD PhD FEBU (+323 821 59 34 ext. +32, stefan.dewachter@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG pelvic floor (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.