Direct Full-stage Implantation of Sacral Neuromodulation
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ClinicalTrials.gov Identifier: NCT03697954 |
Recruitment Status :
Withdrawn
(Work has already been published by other groups)
First Posted : October 5, 2018
Last Update Posted : October 14, 2020
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Condition or disease | Intervention/treatment |
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Urinary Bladder, Overactive Urge Incontinence | Device: full stage implantation of sacral neuromodulation |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Direct Full-stage Implantation of Sacral Neuromodulation |
Estimated Study Start Date : | May 2021 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2023 |

Group/Cohort | Intervention/treatment |
---|---|
overactive bladder patients
Female patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation
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Device: full stage implantation of sacral neuromodulation
full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence |
- Improvement in overactive bladder symptoms [ Time Frame: 1 year ]measured using overactive bladder questionnaire

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697954
United States, California | |
Loma Linda University Faculty Medical Offices | |
Loma Linda, California, United States, 92354 |
Responsible Party: | Andrea Staack, MD PhD, Loma Linda University |
ClinicalTrials.gov Identifier: | NCT03697954 |
Other Study ID Numbers: |
5180114 |
First Posted: | October 5, 2018 Key Record Dates |
Last Update Posted: | October 14, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Urinary Incontinence, Urge Urinary Bladder, Overactive Urinary Incontinence Urination Disorders |
Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Urinary Bladder Diseases |