InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
Phase: NA
Conditions: Overactive Bladder, Urinary Incontinence, Fecal Incontinence
Sponsor: University of Louisville

IRB # 15.0034: Study Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy versus 
Without.
  
Revised Study Protocol dated March 28, 2016                                                                                        Page 1 of 6
Research Protocol 
Project Title: InterStim Implantation Rate Following Percutaneous Nerve Evaluation 
With Fluoroscopy versus Without.
Principal Investigator: Sean Francis MD
Co-Investigators: Casey Kinman MD, Anubhav Agrawal MD,  Kate Meriwether MD 
and Deslyn Hobson MD
Regulatory Coordinator: Sherree Goss RN, CCRC
                                                    University of Louisville, Dept of OB/GYN
                                                    Senior Research Nurse Coordinator/Research Manager for OB/GYN                    
 
Study Sites: 
University of Louisville
University of Louisville HealthCare Outpatient Center (HCOC)
University of Louisville Hospital (ULH) Outpatient Surgery Center at HCOC
Jewish East Medical Center
Revised Protocol Dated March 28, 2016
Protocol Summary/Purpose:
 
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.
We propose a randomized control trial comparing the rate of implantation of the 
InterStim device following (PNE) performed with or without fluoroscopic guidance. 

IRB # 15.0034: Study Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy versus 
Without.
  
Revised Study Protocol dated March 28, 2016                                                                                        Page 2 of 6
Objective: 
To compare rates of implantation of InterStim after percutaneous nerve evaluation (PNE) 
with and without fluoroscopic guidance.
Hypothesis:
There will not be a significant difference in the conversion rate in patients who receive 
PNE placed with fluoroscopy versus those who have PNE placed without fluoroscopy. 
Introduction and Background:
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. Prior to placement of 
the implant, patients must first undergo percutaneous nerve evaluation (PNE) and test 
stimulation. During this outpatient procedure the patient is placed in the prone position 
and a needle is inserted into the S3 foramen bilaterally under local anesthetic. Correct 
placement of the needle is confirmed by eliciting the appropriate nerve stimulation 
responses, and in some cases by the use of fluoroscopy. When correct position is 
achieved, a temporary monopolar percutaneous lead is placed though each needle 
bilaterally and the needles removed. The leads are attached to an external stimulator that 
is worn for a period of 3 to 7 days. Patients keep voiding diaries during the test 
stimulation, and if they demonstrate a 50% or greater improvement in symptoms they are 
eligible for implantation of the permanent tined lead and pacemaker-like stimulator, or 
IPG. Most studies report a 40% to 50% implantation rate following PNE (1). While some 
practitioners reserve fluoroscopic guidance solely for placement of the permanent tined 
lead, some prefer to use fluoroscopy when placing the temporary lead during PNE as 
well.  
Methods and Procedures: 
Patients with refractory urinary or fecal urgency, frequency, or incontinence undergoing 
peripheral nerve evaluation prior to InterStim implantation will be recruited from the 
HCOC Urogynecology outpatient office and will be consented for participation in the 
study during their preoperative office visit or on the day of their procedure. We plan to 
enroll approximately 200 patients in the study. Subject participation will last 
approximately 3 months.

IRB # 15.0034: Study Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy versus 
Without.
  
Revised Study Protocol dated March 28, 2016                                                                                        Page 3 of 6
Patients will be randomized just before PNE by block randomization to either Group 1 or 
Group 2. .
Group 1: Fluoroscopy guided PNE 
Group 2: PNE without fluoroscopic guidance
   
Patients randomized to Group 1 will have their PNE performed in the HCOC outpatient 
surgery center or at the Jewish East Medical Center under local anesthetic with 
fluoroscopic guidance. Fluoroscopy will be used to confirm correct needle and 
subsequent lead placement. 
Patients randomized to Group 2 will also have the PNE performed in the HCOC 
outpatient surgery center or at the Jewish East Medical Center under local anesthetic but 
no fluoroscopy will be used. (This is our current practice for PNEs.)
As is standard practice following PNE, patients will complete a 3-7 day voiding diary pre 
and post procedure, and if a 50% or greater improvement in symptoms (number of voids, 
number of incontinent episodes, or less urgency) is documented they will be eligible for 
implantation of the tined lead and implantable pulse generator (IPG). We will then 
calculate implantation rates between the two groups. 
 
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 Sources:

Electronic medical record at HCOC will be used to collect data
Data Collection: 
The following information will be collected from the electronic medical record and 
entered into an encrypted excel spreadsheet:

IRB # 15.0034: Study Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy versus 
Without.
  
Revised Study Protocol dated March 28, 2016                                                                                        Page 4 of 6

Age

Race

BMI

Preoperative diagnosis

Previous treatments for urinary urgency, frequency, retention, and/or urinary or 
fecal incontinence

Percent improvement in symptoms as determined by pre and post PNE voiding 
diaries

Whether or not InterStim implanted within 3 months of PNE

Date of PNE

Date of implantation of InterStim (if applicable)

PFDI-20, PISQ-12, PFIQ-7 quality of life surveys
Data Analysis and Statistical Methods:
The primary outcome will be the difference in the rate of implantation of InterStim after 
PNE in each group. Secondary outcomes will identify demographic and perioperative 
factors associated with increased rates of implantation.  Demographic factors will include 
age, race, previous treatments, and percent improvement in symptoms as determined by 
pre and post PNE voiding diaries.  Continuous variables will be compared using the non-
paired T-test and categorical variables will be compared using the chi-squared test.
Data Handling/Storage
All identifying information and data collected during the course of this study will be kept 
secure and strictly confidential. All data will be stored electronically on a password 
protected, encrypted laptop in the possession of the study investigators.  Data will NOT 
be stored on a ‘cloud’ type server per HIPAA regulations.  If data is transported, it will be 
transported on an encrypted device such as an encrypted thumb drive, CD, or DVD.
Paper data collections forms will be utilized and data will be entered from the paper data 
form to an encrypted, password protected laptop or computer database.  These data forms 
will be housed in a locked file cabinet in the fellow’s office in OBGYN office in the 
Ambulatory Care Building with restricted access. 
Potential Benefits:
We do not anticipate any direct benefits to our study participants. 

IRB # 15.0034: Study Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy versus 
Without.
  
Revised Study Protocol dated March 28, 2016                                                                                        Page 5 of 6
Potential Risks: 
Risks to PNE include bleeding, bruising, infection, and/or discomfort at the site of lead 
insertion as well as lead migration and  a temporary tingling sensation like that of an 
electrical shock. Should the patient decide to proceed with implantation of the InterStim 
system the same risks apply as well as pain or discomfort at the implant site, device 
malfunction, or undesirable changes in urinary or bowel habits. 
Additionally, this research study cannot practically be conducted without access and use 
of protected health information.  Thus, the principle risk to patients involved in the study 
is a potential breach of confidentiality and misuse or exposure of this information.  With 
this in mind, the investigators will conduct all research activities in such a way that 
maximizes data security and minimizes any risk of potential data breaches.
Protection of Human Subjects/Security of Data/Conduct of Study: 
The investigators will take great care to protect and secure all study data collected for this 
study.  
Risks for breaches of confidentiality will be minimized by entering data from the medical 
record or paper data collection forms to a password protected, encrypted computer 
database which will have limited access to the PI, Co-PIs and sub-investigators.
Personal identifiers (name, DOB, MR #) will be collected and retained in an encrypted  
excel spreadsheet (Key). However, all patient information will be completely de-
identified by using a study code or number instead of identifiers for the purposes of data 
analysis and reporting.
Data will be de-identified as soon as is feasible without compromising the study.  Data 
will be stored as an encrypted file on a password protected laptop computer or encrypted 
thumb drive. Data will NOT be stored on a ‘cloud’ type server per HIPAA regulations.  
A de-identified, password protected, encrypted spread sheet will be provided to the 
statistician for statistical analysis.  Statistical consultants will not be added to this study 
since they will only work with totally de-identified data and will never see actual images 
or medical records.
The protected health information gathered for this study will be destroyed as soon as is 
feasible and will not be reused or disclosed to any other person or entity, except as 
required by law. 

IRB # 15.0034: Study Title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy versus 
Without.
  
Revised Study Protocol dated March 28, 2016                                                                                        Page 6 of 6
The excel “key” spreadsheet listing Research ID #, name, DOB, and, MR# may be 
disclosed to staff at the HCOC so that they may upload the required research documents 
into the Allscripts electronic medical record.  As soon as all data have been collected and 
there is no further need to return to a subject’s medical record, the Excel key(s) linking 
name, DOB and MR # to research ID numbers will be destroyed.  
The research personnel involved in this study Casey Kinman MD, Anubhav Agrawal 
MD,  Sean Francis MD, Kate Meriwether MD, Deslyn Hobson and Sherree Goss RN, 
CCRC (regulatory only) are CITI and HIPAA trained. No additional personnel are 
involved at this time. If new research personnel are added to the study, an amendment 
will be submitted to and approved by the IRB before being allowed to participate in the 
study.
 
Adverse Event Reporting and Data Monitoring:
The research team will closely monitor data collection and assure confidentiality at every 
point during this study. The IRB and appropriate hospital research office will be notified 
immediately of any adverse events, including security breaches of the data, or 
UPIRTSOs, whether expected or unexpected.
References
1. Baxter, Chad, Kim, Ja-Hong: Contrasting the Percutaneous Nerve Evaluation Versus 
Staged Implantation in Sacral Neuromodulation. Curr Urol Rep. Sep 2010; 11(5): 310–
314.