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

NCT02577302 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Urinary Incontinence, Urge

Interventions

DEVICE

CAN-Stim - Protect CAN-Stim System

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.

DEVICE

SNS - InterStim® System

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.

Sponsors & Collaborators

  • Uro Medical Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577302 on ClinicalTrials.gov