Trial Outcomes & Findings for Percutaneous Nerve Evaluation With Fluoroscopy Versus Without (NCT NCT02677753)

Results Overview

Percentage of PNEs that have permanent neuromodulation device implanted by 3 months

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

3 months

Results posted on

2020-06-09

Participant milestones
Measure	Fluoroscopy Guided PNE Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. Fluoroscopy	PNE Without Fluoroscopic Guidance No fluoroscopy will be used during or after the placement of the lead wires.
Overall Study STARTED	37	38
Overall Study COMPLETED	36	38
Overall Study NOT COMPLETED	1	0

Withdrawal data not reported

Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

Baseline characteristics by cohort
Measure	Fluoroscopy Guided PNE n=36 Participants Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. Fluoroscopy	PNE Without Fluoroscopic Guidance n=38 Participants No fluoroscopy will be used during or after the placement of the lead wires.	Total n=74 Participants Total of all reporting groups
Age, Continuous	57.94 years STANDARD_DEVIATION 14.29 • n=5 Participants	57.84 years STANDARD_DEVIATION 14.01 • n=7 Participants	57.89 years STANDARD_DEVIATION 14.15 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian participants	29 Participants n=5 Participants	35 Participants n=7 Participants	64 Participants n=5 Participants
Indication for PNE, Urge urinary incontinence	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants

Timeframe: 3 months

Percentage of PNEs that have permanent neuromodulation device implanted by 3 months

Outcome measures
Measure	Fluoroscopy Guided PNE n=36 Participants Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. Fluoroscopy	PNE Without Fluoroscopic Guidance n=38 Participants No fluoroscopy will be used during or after the placement of the lead wires.
Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy	21 Participants	18 Participants

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Fluoroscopy Guided PNE n=36 participants at risk Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. Fluoroscopy	PNE Without Fluoroscopic Guidance n=38 participants at risk No fluoroscopy will be used during or after the placement of the lead wires.
Renal and urinary disorders Pain, premature of retained lead	13.9% 5/36 • Number of events 5 • Within 3 months after PNE placement Patients were queried at time of procedure as well as post op and adverse events were recorded. The PI also reviewed the charts at completion of study and collected any additional adverse event data	7.9% 3/38 • Number of events 3 • Within 3 months after PNE placement Patients were queried at time of procedure as well as post op and adverse events were recorded. The PI also reviewed the charts at completion of study and collected any additional adverse event data

University of Louisville

Phone: 5025617260

Principal investigator is a sponsor employee There were no sponsors for this study
Publication restrictions are in place

Restriction type: OTHER