Direct Full-stage Implantation of Sacral Neuromodulation
Withdrawn before enrolling
Conditions studied: Urinary Bladder, Overactive, Urge Incontinence
In brief
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.
Key facts
- Study ID
- NCT03697954
- Run by
- Loma Linda University
- People needed
- 0
- Starts
- 2021-05-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2020-10-14
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Loma Linda University Faculty Medical Offices — Loma Linda, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.