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Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Urgent PC Neuromodulation System
Sponsored by
Uroplasty, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Women and men >18 years of age
  • A score of > 4 on the OAB-q short form for urgency (question 1)
  • Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary
  • Self-reported bladder symptoms present > 3 months
  • Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)
  • Off all antimuscarinics for at least 2 weeks prior to enrollment
  • Capable of giving informed consent
  • Ambulatory and able to use a toilet independently, without difficulty
  • Capable and willing to follow all study-related procedures

Exclusion Criteria:

  • Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
  • Neurogenic bladder
  • Botox use in bladder or pelvic floor muscles in the past year
  • Pacemakers or implantable defibrillators
  • Primary complaint of stress urinary incontinence
  • Current urinary tract infection (UTI)
  • Current vaginal infection
  • Current use of InterStim
  • Current use of Bion
  • Current use of TENS in the pelvic region, back or legs
  • Previously been treated with PTNS
  • Use of investigational drug/device therapy within the past 4 weeks
  • Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
  • Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy)
  • Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function

Sites / Locations

  • Gregory L. Davis, M.D., FACOG, Inc.
  • Greenwich Urological Associates, P.C.
  • Specialists in Urology
  • Mercy Health Partners at the Lakes
  • Beaumont Hospital
  • Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
  • Uroplasty, Inc
  • Beaumont Hospital
  • Urology Health Center, PC
  • Capital Region Urological Surgeons, PLLC
  • Central Missouri Women's Healthcare, LLC
  • Alliance Urology Specialists
  • University of Oklahoma
  • Virginia Urology
  • Athena Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Urgent PC

Sham / Placebo

Arm Description

Outcomes

Primary Outcome Measures

The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.
A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2008
Last Updated
April 13, 2012
Sponsor
Uroplasty, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00771264
Brief Title
Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms
Acronym
SUmiT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uroplasty, Inc

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urgent PC
Arm Type
Active Comparator
Arm Title
Sham / Placebo
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Urgent PC Neuromodulation System
Intervention Description
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Primary Outcome Measure Information:
Title
The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.
Description
A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women and men >18 years of age A score of > 4 on the OAB-q short form for urgency (question 1) Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary Self-reported bladder symptoms present > 3 months Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) Off all antimuscarinics for at least 2 weeks prior to enrollment Capable of giving informed consent Ambulatory and able to use a toilet independently, without difficulty Capable and willing to follow all study-related procedures Exclusion Criteria: Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period Neurogenic bladder Botox use in bladder or pelvic floor muscles in the past year Pacemakers or implantable defibrillators Primary complaint of stress urinary incontinence Current urinary tract infection (UTI) Current vaginal infection Current use of InterStim Current use of Bion Current use of TENS in the pelvic region, back or legs Previously been treated with PTNS Use of investigational drug/device therapy within the past 4 weeks Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy) Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function
Facility Information:
Facility Name
Gregory L. Davis, M.D., FACOG, Inc.
City
Chico
State/Province
California
ZIP/Postal Code
95928
Country
United States
Facility Name
Greenwich Urological Associates, P.C.
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Specialists in Urology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Mercy Health Partners at the Lakes
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48703
Country
United States
Facility Name
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
City
Grand Rapids
State/Province
Minnesota
ZIP/Postal Code
49503
Country
United States
Facility Name
Uroplasty, Inc
City
Minnetonka
State/Province
Minnesota
ZIP/Postal Code
55343
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Minnesota
ZIP/Postal Code
48073
Country
United States
Facility Name
Urology Health Center, PC
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Capital Region Urological Surgeons, PLLC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Central Missouri Women's Healthcare, LLC
City
White Plains
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Athena Urology
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms

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