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CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology (PROTECT)

Primary Purpose

Urinary Incontinence, Urge

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAN-Stim - Protect CAN-Stim System
SNS - InterStim® System
Sponsored by
Uro Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring Chronic Tibial nerve stimulation, Wireless PNS, neuromodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge, as confirmed by the MESA questionnaire;
  • Women and men ≥ 18 years of age;
  • Women of child-bearing age willing to practice birth control;
  • At least 4 incontinent episodes associated with urgency on a 3-day voiding diary;
  • At least 10 voids per day;
  • Average urgency score of at least 2 as measured with IUSS on a 3-day voiding diary;
  • Self-reported bladder symptoms present > 6 months;
  • Documented failure of an adequate trial of first and second line therapy;
  • Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment;
  • If on Tricyclic antidepressants, dosage must be stabilized for at least 3 months;
  • Have no active urethral obstruction/stricture, bladder calculi or bladder tumor based on medical history;
  • Normal upper urinary tract function based on medical history;
  • Based on the medical opinion of the Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
  • Based on the medical opinion of the Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
  • Based on the medical opinion of the Investigator, subject is a good surgical subject for the implant procedure;
  • Capable of giving informed consent;
  • Capable and willing to follow all study related procedures.

Exclusion Criteria:

  • An active implantable electronic device regardless of whether stimulation is ON or OFF;
  • Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period;
  • Primary complaint of stress urinary incontinence;
  • Less than 1 year post-partum and/or are breast-feeding;
  • Neurogenic bladder (i.e. Multiple sclerosis, Parkinson's, Spinal Cord Injury);
  • Patients with spinal hardware that would limit access to the sacrum;
  • Botox use in bladder or pelvic floor muscles in the past nine months;
  • Have a post-void residual urine volume >150 cc at baseline;
  • Current urinary tract infection (UTI);
  • Previous treatment with sacral neuromodulation;
  • Previous treatment with percutaneous tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days;
  • Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures;
  • Inability to operate the CAN-Stim System or InterStim System;
  • Diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C 8.5 or greater);
  • History of coagulopathy or bleeding disorder;
  • History of pelvic pain as primary diagnosis (VAS score of > 4) at baseline;
  • Anatomical restrictions such that device placement is not possible;
  • Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function;
  • Have a life expectancy of less than 1 year;
  • Cannot independently comprehend and complete the questionnaires and diaries;
  • Deemed unsuitable for enrollment by the investigator based on history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy);
  • Dependent on wearable, transcutaneous, or other therapeutic medical device (examples: glucose monitor, TENS) for treatment of a disease or disorder.

Sites / Locations

  • Tilda Research IncRecruiting
  • Kaiser PermanenteRecruiting
  • University of California Irvine Medical CenterRecruiting
  • Westview Clinical ResearchRecruiting
  • Advanced Urology InstituteRecruiting
  • Baptist Health Miami Cancer Institute
  • Florida Urology PartnersRecruiting
  • William Beaumont HospitalRecruiting
  • St. Louis Pain ConsultantsRecruiting
  • Adult & Pediatric Urology, P.C.Recruiting
  • Urology - Iris Cantor Men's Health CenterRecruiting
  • Stony Brook University Medical CenterRecruiting
  • Integrated Pain SpecialistsRecruiting
  • University of Oklahoma health Sciences Center
  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAN-Stim Group - CAN-Stim System

SNS Group - Interstim® System

Arm Description

Intervention: tibial medical device Subjects randomized to this group will have the Protect CAN-Stim System tibial medical device implanted for the duration of the study.

Intervention: SNS Medical device Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study.

Outcomes

Primary Outcome Measures

Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
The primary efficacy endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 3 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is taken as an average of two 3-day consecutive bladder diaries, with at least 24 hours between when the first diary ends and the second diary begins
device- and procedure-related Adverse Events (AE)
The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 3 months in the CAN-Stim and SNS groups.

Secondary Outcome Measures

Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
The endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 6 and 12 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is collected with a voiding diary.
device- and procedure-related Adverse Events (AE)
The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 6 and 12 months in the CAN-Stim and SNS groups.
Voiding Frequency
The achievement in each subject of a ≥ 50% reduction in the number of voids or a return to normal voiding frequency (< 8 voids/day) from baseline to 3-, 6-, and 12-month follow-up in the CAN-stim group compared to the InterStim® group;
Reduction in degree of urgency
A reduction in the degree of urgency as measured with the Indevus Urgency Severity Scale (IUSS) in the CAN-Stim group compared to the InterStim® group.

Full Information

First Posted
October 12, 2015
Last Updated
October 3, 2023
Sponsor
Uro Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02577302
Brief Title
CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology
Acronym
PROTECT
Official Title
Multi-center, Prospective, Randomized, Controlled, Non-Inferiority, Clinical Trial of Chronic Afferent Nerve Stimulation (CAN-Stim) of the Tibial Nerve Versus Sacral Nerve Stimulation (SNS) in the Treatment of Urinary Urgency Incontinence Resulting From Refractory Overactive Bladder (OAB)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uro Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. The primary endpoint is a ≥ 50% reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9 and 12-months.
Detailed Description
Subjects will be randomized at baseline to either CAN-Stim or SNS InterStim® after inclusion and exclusion criteria have been met, 150 subjects will be randomized in to either arm of the study (89 subjects each arm). At the following visit, CAN-Stim subjects will be immediately implanted unilaterally with a permanent device (implantation side up to investigators discretion). During implantation, the subject should feel pulsation in their foot with or without toe flexion, confirming stimulation of the tibial nerve. Subjects not achieving this motor response will not have the device implanted and will be exited from the study. Implanted subjects will be educated on the use of the transmitter and programmer. Programming parameters will be set and therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Programming changes can be done as needed during this time period to maximize clinical response. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Subjects who are considered a responder at the 2-week follow-up visit (>50% improvement in urgency related incontinence episodes) will continue therapy and followed for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months. Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study. Subjects, who respond intraoperatively, will have the extension lead connected and externalized in the standard fashion. Subjects may have their InterStim® activated 24 hours/day, but a minimum of 8 hours per day for 2 weeks is required to remain in the study. Programming changes can be done as needed during this time period to maximize the clinical effect. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and clarified for discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Patients achieving a clinical response (>50% improvement in urgency related incontinence episodes) will undergo implantation of a pulse generator and removal of the percutaneous extension lead. The IPG will be programmed in the standard fashion using settings that were working for the patient during the 2-week trial. Subjects implanted with the InterStim® device will be monitored for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
Keywords
Chronic Tibial nerve stimulation, Wireless PNS, neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized, Controlled, Non-Inferiority
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAN-Stim Group - CAN-Stim System
Arm Type
Experimental
Arm Description
Intervention: tibial medical device Subjects randomized to this group will have the Protect CAN-Stim System tibial medical device implanted for the duration of the study.
Arm Title
SNS Group - Interstim® System
Arm Type
Active Comparator
Arm Description
Intervention: SNS Medical device Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study.
Intervention Type
Device
Intervention Name(s)
CAN-Stim - Protect CAN-Stim System
Intervention Description
CAN-Stim subjects will be implanted unilaterally (implantation side is up to the investigators discretion) with the CAN-Stim System. Subjects will be educated on the use of the transmitter and programmer. Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will continue therapy and followed for a total of 12 months.
Intervention Type
Device
Intervention Name(s)
SNS - InterStim® System
Intervention Description
Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study.Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will receive a full implant and followed for a total of 12 months.
Primary Outcome Measure Information:
Title
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
Description
The primary efficacy endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 3 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is taken as an average of two 3-day consecutive bladder diaries, with at least 24 hours between when the first diary ends and the second diary begins
Time Frame
3 Months
Title
device- and procedure-related Adverse Events (AE)
Description
The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 3 months in the CAN-Stim and SNS groups.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
Description
The endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 6 and 12 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is collected with a voiding diary.
Time Frame
6,12 Months
Title
device- and procedure-related Adverse Events (AE)
Description
The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 6 and 12 months in the CAN-Stim and SNS groups.
Time Frame
6,12 Months
Title
Voiding Frequency
Description
The achievement in each subject of a ≥ 50% reduction in the number of voids or a return to normal voiding frequency (< 8 voids/day) from baseline to 3-, 6-, and 12-month follow-up in the CAN-stim group compared to the InterStim® group;
Time Frame
3, 6,12 Months
Title
Reduction in degree of urgency
Description
A reduction in the degree of urgency as measured with the Indevus Urgency Severity Scale (IUSS) in the CAN-Stim group compared to the InterStim® group.
Time Frame
3, 6,12 Months
Other Pre-specified Outcome Measures:
Title
Quality of Life: I-QOL: Quality of Life Scale (I-QOL)
Description
Change in the Urinary Incontinence Quality of Life Scale (I-QOL) in the CAN-Stim group compared to the InterStim® group
Time Frame
3, 6,12 Months
Title
Proportion of subjects dry
Description
B. The proportion of subjects dry as measured by the number of incontinence episodes per day associated with urgency as captured on the voiding diary.
Time Frame
3, 6,12 Months
Title
Episodes
Description
The number of episodes associated with urgency as illustrated by voiding diaries
Time Frame
3, 6,12 Months
Title
Improvement
Description
Global Response Assessment (GRA) will be used to compare the proportion of subjects reporting "moderately" or "markedly improved" responses on all subject visits
Time Frame
3, 6,12 Months
Title
OAB
Description
Overactive Bladder Questionnaire Short Form (OAB-Q)
Time Frame
3, 6,12 Months
Title
AE's
Description
Adverse events both related or unrelated in the CAN-Stim group compared to the InterStim® group throughout the study
Time Frame
6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge, as confirmed by the MESA questionnaire; Women and men ≥ 18 years of age; Women of child-bearing age willing to practice birth control; At least 4 incontinent episodes associated with urgency on a 3-day voiding diary; At least 10 voids per day; Average urgency score of at least 2 as measured with IUSS on a 3-day voiding diary; Self-reported bladder symptoms present > 6 months; Documented failure of an adequate trial of first and second line therapy; Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment; If on Tricyclic antidepressants, dosage must be stabilized for at least 3 months; Have no active urethral obstruction/stricture, bladder calculi or bladder tumor based on medical history; Normal upper urinary tract function based on medical history; Based on the medical opinion of the Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject; Based on the medical opinion of the Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses; Based on the medical opinion of the Investigator, subject is a good surgical subject for the implant procedure; Capable of giving informed consent; Capable and willing to follow all study related procedures. Exclusion Criteria: An active implantable electronic device regardless of whether stimulation is ON or OFF; Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period; Primary complaint of stress urinary incontinence; Less than 1 year post-partum and/or are breast-feeding; Neurogenic bladder (i.e. Multiple sclerosis, Parkinson's, Spinal Cord Injury); Patients with spinal hardware that would limit access to the sacrum; Botox use in bladder or pelvic floor muscles in the past nine months; Have a post-void residual urine volume >150 cc at baseline; Current urinary tract infection (UTI); Previous treatment with sacral neuromodulation; Previous treatment with percutaneous tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days; Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures; Inability to operate the CAN-Stim System or InterStim System; Diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C 8.5 or greater); History of coagulopathy or bleeding disorder; History of pelvic pain as primary diagnosis (VAS score of > 4) at baseline; Anatomical restrictions such that device placement is not possible; Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function; Have a life expectancy of less than 1 year; Cannot independently comprehend and complete the questionnaires and diaries; Deemed unsuitable for enrollment by the investigator based on history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy); Dependent on wearable, transcutaneous, or other therapeutic medical device (examples: glucose monitor, TENS) for treatment of a disease or disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Chery
Phone
888-691-0585
Email
contact@micronmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shanice Saunders
Phone
888-691-0585
Email
contact@micronmed.com
Facility Information:
Facility Name
Tilda Research Inc
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Deck
Phone
949-680-3490
Email
jdeck@tilda.bio
First Name & Middle Initial & Last Name & Degree
Kenneth Deck, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Gruenenfelder, MD
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Gallegos
Phone
323-783-5081
Email
Isabel.Gallegos@kp.org
First Name & Middle Initial & Last Name & Degree
Christopher Tenggardjaja
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuong Linh Huynh, MPH
Phone
714-456-6155
Email
plhuynh@uci.edu
First Name & Middle Initial & Last Name & Degree
Felicia Lane, MD
Facility Name
Westview Clinical Research
City
Placentia
State/Province
California
ZIP/Postal Code
92870
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uyen Kim Hoang
Phone
562-343-7181
Email
uyenhoang@wcr8.com
First Name & Middle Initial & Last Name & Degree
Albert Lai, MD
First Name & Middle Initial & Last Name & Degree
Michael Gazzaniga, MD
Facility Name
Advanced Urology Institute
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonelle Horsley
Phone
386-239-8500
Email
jonelle.horsley@auihealth.com
First Name & Middle Initial & Last Name & Degree
Jorge Rodriguez
Phone
386-239-8500
Email
jorge.rodriguez@auihealth.com
First Name & Middle Initial & Last Name & Degree
Matthew Merrell, MD
Facility Name
Baptist Health Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Withdrawn
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Seibert
Phone
239-223-4488
Email
linda@gulfcoastcta.com
First Name & Middle Initial & Last Name & Degree
Osvaldo Padron
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Schonhoff, RN
Phone
248-551-1225
Email
Amanda.Schonhoff@beaumont.org
First Name & Middle Initial & Last Name & Degree
Angela Waldvogel, RN
Phone
(248) 551 2572
Email
Angela.Waldvogel@beaumont.org
First Name & Middle Initial & Last Name & Degree
Larry Sirls, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
First Name & Middle Initial & Last Name & Degree
Jason Gilleran, MD
Facility Name
St. Louis Pain Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kermit Mclauchlin
Email
kermet.mclauchlin@stl-pain.com
First Name & Middle Initial & Last Name & Degree
Kim Scally
Phone
314-315-9905
Email
kimS@metrourology.net
First Name & Middle Initial & Last Name & Degree
Anne Christopher, MD
First Name & Middle Initial & Last Name & Degree
Cathy Naughton, MD
Facility Name
Adult & Pediatric Urology, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
10707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Nelson
Phone
402-399-7892
Email
Anelson@adultpediatricuro.com
First Name & Middle Initial & Last Name & Degree
Rebecca McCrery, MD
Facility Name
Urology - Iris Cantor Men's Health Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahra Cho
Phone
646-962-9395
Email
ahc4001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Bilal Chughtai, MD
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Brand
Phone
631-813-0540
Email
Margaret.brand@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Jason Kim, MD
Facility Name
Integrated Pain Specialists
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Simons
Phone
614-383-6450
Ext
5
Email
msimons.ips@gmail.com
First Name & Middle Initial & Last Name & Degree
Rachel Garey
Phone
614-264-7070
Email
rgarey@centralohiourology.com
First Name & Middle Initial & Last Name & Degree
Gladstone McDowell, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Carey, MD
Facility Name
University of Oklahoma health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Beaver
Phone
214-645-8787
Email
Allison.Beaver@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Gary Lemack, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
upon study completion

Learn more about this trial

CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology

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