N/A
N=75
Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
Overactive Bladder · Urinary Incontinence · Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02677753 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy — 21; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluoroscopy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Louisville
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy |
21; 18 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02677753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.