NCT01464372

Brief Summary

The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

October 31, 2011

Last Update Submit

January 30, 2013

Conditions

Urinary Incontinence, Urge

Keywords

Urinary Incontinence, UrgePeripheral Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

  • Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm

    Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham

    One week after final treatment visit

  • No Serious Adverse Events or Unanticipated Adverse Device Effects

    Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up

    First treatment through follow-up (one week after last treatment)

Study Arms (2)

Investigational Device

EXPERIMENTAL

Treatment using electrical field stimulation of peripheral nerves

Device: Electrical Field Stimulation Device

Sham Device

SHAM COMPARATOR

Control group using sham device to mimic sound and sensation of investigational device

Device: Sham Nerve Stimulation Device

Interventions

Electrical Field Stimulation DeviceDEVICE

Treatment with Electrical Field Stimulation Device

Investigational Device
Sham Nerve Stimulation DeviceDEVICE

Use of the sham device

Sham Device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urinary Urge Incontinence
  • Urinary Frequency

You may not qualify if:

  • Primary complaint of Stress Incontinence
  • Neurogenic bladder
  • Overflow Incontinence
  • Functional Incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth Peters, MD

    Birmingham Urologic Associates

    PRINCIPAL INVESTIGATOR

  • Scott MacDiarmid, MD

    Alliance Urology Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 3, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

January 31, 2013

Record last verified: 2013-01