Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

• Sponsor: University of Louisville (Other)
• Overall Status: Completed
• CT.gov ID: NCT02677753
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Urinary Incontinence; Fecal Incontinence	Radiation: Fluoroscopy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fluoroscopy guided PNE Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires.	Radiation: Fluoroscopy
No Intervention: PNE without fluoroscopic guidance No fluoroscopy will be used during or after the placement of the lead wires.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville Physicians	Louisville	Kentucky	United States	40205

Sponsors and Collaborators

• University of Louisville

Investigators

• Principal Investigator: Sean L Francis, MD, University of Louisville

Study Documents (Full-Text)

• Informed Consent Form - May 7, 2018
• Study Protocol and Statistical Analysis Plan - Mar 28, 2016

More Information

Publications

None provided.

• Responsible Party: Sean Francis, Principal investigator, University of Louisville
• ClinicalTrials.gov Identifier: NCT02677753
• Other Study ID Numbers: 15.0034
• First Posted: Feb 9, 2016
• Last Update Posted: Jun 9, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Fecal Incontinence; Urinary Incontinence; Urinary Bladder, Overactive

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Fluoroscopy Guided PNE	PNE Without Fluoroscopic Guidance	Total
Arm/Group Description	Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. Fluoroscopy	No fluoroscopy will be used during or after the placement of the lead wires.	Total of all reporting groups
Overall Participants	36	38	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.94 (14.29)	57.84 (14.01)	57.89 (14.15)
Sex: Female, Male (Count of Participants)
Female	36 100%	38 100%	74 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian participants	29 80.6%	35 92.1%	64 86.5%
Indication for PNE, Urge urinary incontinence (Count of Participants)
Count of Participants [Participants]	30 83.3%	33 86.8%	63 85.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy
Description	Percentage of PNEs that have permanent neuromodulation device implanted by 3 months
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoroscopy Guided PNE	PNE Without Fluoroscopic Guidance
Arm/Group Description	Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. Fluoroscopy	No fluoroscopy will be used during or after the placement of the lead wires.
Measure Participants	36	38
Count of Participants [Participants]	21 58.3%	18 47.4%

Adverse Events

Time Frame	Within 3 months after PNE placement
Adverse Event Reporting Description	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
Arm/Group Title	Fluoroscopy Guided PNE		PNE Without Fluoroscopic Guidance
Arm/Group Description	Fluoroscopy will be utilized to assist with placement and/or confirm correct placement of lead wires. Fluoroscopy		No fluoroscopy will be used during or after the placement of the lead wires.
All Cause Mortality
	Fluoroscopy Guided PNE		PNE Without Fluoroscopic Guidance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/38 (0%)
Serious Adverse Events
	Fluoroscopy Guided PNE		PNE Without Fluoroscopic Guidance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Fluoroscopy Guided PNE		PNE Without Fluoroscopic Guidance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/36 (13.9%)		3/38 (7.9%)
Renal and urinary disorders
Pain, premature of retained lead	5/36 (13.9%)	5	3/38 (7.9%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There were no sponsors for this study