Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation

NCT02434874 | Withdrawn DMC FDA Device

• 1 other identifier: 06-00780
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pivotal study is to illustrate the safety and effectiveness of the StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92 subjects will receive a StimGuard SNS System.

Conditions

Urinary Incontinence, Urge

Outcome Measures

Primary Outcomes (2)

• Reduction in number of urge related incontinence episodes

  Self reported on a 3-day voiding diary

  3 Months

• Incidence and severity of adverse events

  Up to 12 months

Secondary Outcomes (3)

• Proportion of subjects with a reduction in the degree of urgency as measured by PPIUS

  3 Months

• Proportion of subjects with a reduction in the number of voids compared to baseline

  3 Months

• Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)

  3 Months

Other Outcomes (5)

• Proportion of subjects dry

  12 months

• Number of Episodes associated with urge

  12 months

• Proportion of subjects reporting improvement

  12 Months

Study Arms (2)

Immediate Activation

EXPERIMENTAL

Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated immediately.

Device: StimGuard Sacral Nerve Stimulator System

Delayed Activation

OTHER

Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated after 90 days.

Device: StimGuard Sacral Nerve Stimulator System

Interventions

StimGuard Sacral Nerve Stimulator System DEVICE

The StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence. This technology includes a quadripolar stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin and to the receiver.

Delayed Activation; Immediate Activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Diagnosis of overactive bladder with urgency urinary incontinence; B. Women and men ≥ 18 years of age; C. At least 4 incontinent episodes associated with urge on a 3 day voiding diary with at least 1 each 24 hour day; D. Self-reported bladder symptoms present \> 6 months; E. Self-reported failed conservative care \> 6 months (i.e., pharmacology, dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.); F. Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment; G. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor; H. Normal upper urinary tract function; I. Capable of giving informed consent; J. Capable and willing to follow all study related procedures.

You may not qualify if:

• A. Any active implantable electronic device regardless of whether stimulation is ON or OFF; B. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period; C. Less than 1 year post partum and/or are breast-feeding; D. Neurogenic bladder; E. Botox use in bladder or pelvic floor muscles in the past six months; F. Taking alpha-blocker therapy; G. Have a PVR \>150 cc at baseline; H. Primary complaint of stress urinary incontinence; I. Current urinary tract infection (UTI); J. Previous treatment with sacral neuromodulation; K. Previous treatment with tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days; L. Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures; M. Inability to operate the StimGuard SNS System; N. Diabetes with peripheral nerve involvement or have severe uncontrolled diabetes (HbA1C 8.5 or greater); O. History of coagulopathy or bleeding disorder; P. History of pelvic pain as primary diagnosis (VAS score of \> 4); Q. Anatomical restrictions such that device placement is not possible; R. Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function; S. Life expectancy of less than 5 years; T. Inability to independently comprehend and complete the questionnaires and diaries; U. Unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy).

Sponsors & Collaborators

• Uro Medical Corporation: lead

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 5, 2015
• Study Start: March 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

US (1)