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Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms (STEP)

Primary Purpose

Urinary Bladder, Overactive

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

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Urgent PC, Overactive Bladder, SUmiT Trial, Overactive Urinary Bladder

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
  • Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
  • Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
  • Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
  • Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
  • Subjects must remain off all antimuscarinics throughout participation in trial
  • Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
  • Capable of giving informed consent
  • Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years

Exclusion Criteria:

  • Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
  • Subjects who were not able or willing to follow original SUmiT Trial study schedule

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Urgent PC

Arm 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).

Outcomes

Primary Outcome Measures

Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).

Secondary Outcome Measures

GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
Change in OAB-q and SF-36 Questionnaires.
Change in Voiding Diary Parameters.

Full Information

First Posted
June 24, 2009
Last Updated
April 4, 2013
Sponsor
Uroplasty, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00928395
Brief Title
Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
Acronym
STEP
Official Title
Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urgent PC
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Urgent PC
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
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
Description
The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).
Time Frame
36 months total
Secondary Outcome Measure Information:
Title
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
Time Frame
every three months for 36 months
Title
Change in OAB-q and SF-36 Questionnaires.
Time Frame
every three months for 36 months
Title
Change in Voiding Diary Parameters.
Time Frame
every three months for 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial Subjects must remain off all antimuscarinics throughout participation in trial Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008 Capable of giving informed consent Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years Exclusion Criteria: Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period Subjects who were not able or willing to follow original SUmiT Trial study schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
Beaumont Hospital
Official's Role
Principal Investigator
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
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
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
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
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

Citations:
PubMed Identifier
22674493
Citation
Peters KM, Carrico DJ, MacDiarmid SA, Wooldridge LS, Khan AU, McCoy CE, Franco N, Bennett JB. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5.
Results Reference
derived

Learn more about this trial

Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms

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