Clinical trial NCT00928395: Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
Official title: Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: Urgent PC
Overactive Bladder
SUmiT Trial
Overactive Urinary Bladder
Lead sponsor: Uroplasty, Inc
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
timeFrame: 36 months total
Secondary outcomes:
measure: GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
timeFrame: every three months for 36 months
measure: Change in OAB-q and SF-36 Questionnaires.
timeFrame: every three months for 36 months
measure: Change in Voiding Diary Parameters.
timeFrame: every three months for 36 months
Other outcomes:
Locations:
city: Chico
country: United States
facility: Gregory L. Davis, M.D., FACOG, Inc.
state: California
city: Greenwich
country: United States
facility: Greenwich Urological Associates, P.C.
state: Connecticut
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Grand Rapids
country: United States
facility: Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
state: Michigan
city: Muskegon
country: United States
facility: Mercy Health Partners at the Lakes
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Fremont
country: United States
facility: Urology Health Center, PC
state: Nebraska
city: Albany
country: United States
facility: Capital Region Urological Surgeons, PLLC
state: New York
city: White Plains
country: United States
facility: Central Missouri Women's Healthcare, LLC
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Issaquah
country: United States
facility: Athena Urology
state: Washington
Study officials:
affiliation: Beaumont Hospital
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.