Urinary Bladder, OveractiveNCT03697954
Direct Full-stage Implantation of Sacral Neuromodulation
An observational study of Urinary Bladder, Overactive and Urge Incontinence, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Urge Incontinence
- What is being tested?
- full stage implantation of sacral neuromodulation
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2021to Dec 2023
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation.
Who may be able to join
- Patients >18 years of age
- Female gender
- Refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents
- Willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative)
- Willing and able to complete study questionnaires, use Medtronic device programmer, return for scheduled follow-up appointments
- Surgical candidate able to hold antiplatelet or anticoagulation prior to surgery
- Health insurance provider that will cover full-stage implantation
Who cannot join
- Age <18
- Pregnant or planning to become pregnant
- Male gender
- Unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period
- Treatment with botulinum toxin within last 6 months
- Recent surgery for stress urinary incontinence or pelvic organ prolapse within last 6 months
Show all 18Show fewer
- Severe pelvic organ prolapse
- Post-void residual >150 ml
- Symptomatic or recurrent urinary tract infection
- Neurologic disorders: cerebrovascular accident with neurologic deficits, Parkinson's, multiple sclerosis, spinal cord injury, significant peripheral neuropathy
- Cognitive disorders, e.g. dementia
- Interstitial cystitis or chronic pelvic pain syndrome
- Poorly controlled diabetes mellitus (HbA1c >10%)
- History of bladder malignancy, pelvic radiation, urinary retention requiring catheterization
- Anticipated or known need for MRI at the trunk
- History of or anticipated surgery at the lower back
- Unable to hold antiplatelet or anticoagulation prior to surgery
- Life expectancy <1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Faculty Medical Offices
Loma Linda, California, 92354
About this study
The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization.
- Conditions
- Urinary Bladder, Overactive, Urge Incontinence
- Being tested
- full stage implantation of sacral neuromodulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full stage implantation of sacral neuromodulationDevice
full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence
| Study group | Role | What they receive |
|---|---|---|
| overactive bladder patients | Female patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation Receives: Device: full stage implantation of sacral neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in overactive bladder symptoms
measured using overactive bladder questionnaire
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 posted5 Oct 2018
- Study startMay 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Work has already been published by other groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Staack, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697954
- Sponsor's protocol ID
- 5180114
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.
PubMed 21231991Ganz ML, Smalarz AM, Krupski TL, Anger JT, Hu JC, Wittrup-Jensen KU, Pashos CL. Economic costs of overactive bladder in the United States. Urology. 2010 Mar;75(3):526-32, 532.e1-18. doi: 10.1016/j.urology.2009.06.096. Epub 2009 Dec 29.
PubMed 20035977Coyne KS, Sexton CC, Irwin DE, Kopp ZS, Kelleher CJ, Milsom I. The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well-being in men and women: results from the EPIC study. BJU Int. 2008 Jun;101(11):1388-95. doi: 10.1111/j.1464-410X.2008.07601.x.
PubMed 18454794Latini JM, Alipour M, Kreder KJ Jr. Efficacy of sacral neuromodulation for symptomatic treatment of refractory urinary urge incontinence. Urology. 2006 Mar;67(3):550-3; discussion 553-4. doi: 10.1016/j.urology.2005.09.066.
PubMed 16527577Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.079. Epub 2012 Oct 24.
PubMed 23098785
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Full-stage Implantation of Sacral Neuromodulation
- ClinicalTrials.gov ID
- NCT03697954
- Acronym / sponsor ID
- 5180114
- Conditions
- Urinary Bladder, Overactive, Urge Incontinence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Work has already been published by other groups
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Oct 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.
The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| overactive bladder patients | – | Device: full stage implantation of sacral neuromodulationFemale patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation.
Key inclusion criteria (7 listed)
- Patients >18 years of age
- Female gender
- Refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents
- Willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative)
- Willing and able to complete study questionnaires, use Medtronic device programmer, return for scheduled follow-up appointments
Key exclusion criteria (18 listed)
- Age <18
- Pregnant or planning to become pregnant
- Male gender
- Unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period
- Treatment with botulinum toxin within last 6 months
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 |
|---|---|---|
| full stage implantation of sacral neuromodulationfull stage implantation of sacral neuromodulation for overactive bladder and urge incontinence | Device | overactive bladder patients |
Primary outcome
Improvement in overactive bladder symptoms
Time frame: 1 year
measured using overactive bladder questionnaire
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 21231991Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.
- Background: PubMed 20035977Ganz ML, Smalarz AM, Krupski TL, Anger JT, Hu JC, Wittrup-Jensen KU, Pashos CL. Economic costs of overactive bladder in the United States. Urology. 2010 Mar;75(3):526-32, 532.e1-18. doi: 10.1016/j.urology.2009.06.096. Epub 2009 Dec 29.
- Background: PubMed 18454794Coyne KS, Sexton CC, Irwin DE, Kopp ZS, Kelleher CJ, Milsom I. The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well-being in men and women: results from the EPIC study. BJU Int. 2008 Jun;101(11):1388-95. doi: 10.1111/j.1464-410X.2008.07601.x.
- Background: PubMed 16527577Latini JM, Alipour M, Kreder KJ Jr. Efficacy of sacral neuromodulation for symptomatic treatment of refractory urinary urge incontinence. Urology. 2006 Mar;67(3):550-3; discussion 553-4. doi: 10.1016/j.urology.2005.09.066.
- Background: PubMed 23098785Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.079. Epub 2012 Oct 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Urinary Bladder, Overactive and Urge Incontinence, run by Loma Linda University at 1 site in United States.
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 7 inclusion and 18 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: withdrawn, as of the sponsor's last update on 14 Oct 2020. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in overactive bladder symptoms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03697954, which also lists 5 linked publications.
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 14 Oct 2020.