Overactive Bladder, Urinary Incontinence, Fecal Incontinence
Conditions
Brief summary
The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without fluoroscopic guidance.
Detailed description
Sacral nerve stimulation (SNS) is a well-established treatment for refractory urinary urgency, frequency, retention and urge incontinence as well as fecal incontinence. Patients whose symptoms are refractory to more conservative therapies such as behavioral modification and/or medications are candidates for SNS. The InterStim system consists of a permanent tined lead and implantable pulse generator (IPG) or battery that delivers the sacral neuromodulation. This device is typically implanted after patients have a successful response to a trial of sacral neuromodulation with a temporary lead and external battery. The temporary lead placement is known as a Percutaneous Nerve Evaluation (PNE) and is typically done in as an outpatient procedure using local anesthetic. It is standard practice to use fluoroscopy intraoperatively to confirm correct placement of the permanent lead. Additionally, some physicians also use fluoroscopy to confirm correct placement of temporary lead during PNE while others place the lead based on anatomical landmarks and expected elicited responses for S3 stimulation. The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following (PNE) performed with or without fluoroscopic guidance.
Interventions
RADIATIONFluoroscopy
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women age \>18 * English speakers * Patients with urinary urgency, frequency, or urge incontinence refractory to at least 1 other intervention who elect to undergo PNE
Exclusion criteria
* Patients in whom bilateral leads cannot be placed * Pregnant women * Prisoners * Less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy | 3 months | Percentage of PNEs that have permanent neuromodulation device implanted by 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluoroscopy Guided PNE Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.
Fluoroscopy | 36 |
| PNE Without Fluoroscopic Guidance No fluoroscopy will be used during or after the placement of the lead wires. | 38 |
| Total | 74 |
Baseline characteristics
| Characteristic | Fluoroscopy Guided PNE | PNE Without Fluoroscopic Guidance | Total |
|---|---|---|---|
| Age, Continuous | 57.94 years STANDARD_DEVIATION 14.29 | 57.84 years STANDARD_DEVIATION 14.01 | 57.89 years STANDARD_DEVIATION 14.15 |
| Indication for PNE, Urge urinary incontinence | 30 Participants | 33 Participants | 63 Participants |
| Race/Ethnicity, Customized Caucasian participants | 29 Participants | 35 Participants | 64 Participants |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 38 |
| other Total, other adverse events | 5 / 36 | 3 / 38 |
| serious Total, serious adverse events | 0 / 36 | 0 / 38 |
Outcome results
Primary
Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy
Percentage of PNEs that have permanent neuromodulation device implanted by 3 months
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluoroscopy Guided PNE | Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy | 21 Participants |
| PNE Without Fluoroscopic Guidance | Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy | 18 Participants |