Clinical trial NCT03559946: Condensed Percutaneous Tibial Nerve Stimulation (PTNS) Protocol
Official title: A Randomized Controlled Trial Comparing the Efficacy of a Condensed (Twice Weekly) Protocol to the Standard (Once Per Week) Protocol of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Overactive Bladder Syndrome (OAB)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: Overactive Bladder Syndrome
Percutaneous Tibial Nerve Stimulation
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Laborie Medical Technologies Inc.
First posted: 2018-06-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will be recruiting 66 patients, who will be randomized (1:1) to either the Standard Protocol (SP) group or the Condensed Protocol (CP) group.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand how the frequency of PTNS sessions impacts their efficacy in the treatment of over active bladder syndrome.

Detailed description: This study aims to evaluate the impact of the periodicity of the PTNS treatments on the efficacy of treating patients with OAB. We will compare the efficacy of a condensed (twice weekly) protocol to the standard (once per week) protocol of PTNS therapy.

Objective #1 (6-wk CP vs. 12-wk SP) is to show that 6 weeks of the condensed protocol (CP) will yield a higher efficacy compared to the standard 12-week protocol (SP). If this 6-week CP is proven effective, candidates for PTNS treatment could potentially experience symptom relief in half the time as the current standard of care, improving their quality of life quicker. Objective #2 (12-wk CP vs. 12-wk SP) is to show that 12 weeks of the CP will have a higher efficacy compared to the 12-week SP. If the superiority of this 12-week CP is proven, it could be beneficial in treating patients with refractory OAB.

Eligibility criteria: Inclusion Criteria:

* Women and men (18 years of age and older) with overactive bladder syndrome, who are interested in receiving PTNS treatment.

Exclusion Criteria:

* Patients with anatomical limitations preventing successful placement of the electrode, medical disorders precluding stimulation (bleeding disorders, cardiac pacemakers, peripheral vascular disease or ulcers, or lower leg cellulitis).
* Pregnant women or women who are planning to become pregnant during the course of the study.

Primary outcomes:
measure: Global Response Assessment (GRA)
timeFrame: At week 6 and week 12
Secondary outcomes:
measure: Incontinence impact questionnaire-7 (IIQ-7)
timeFrame: At week 0, 6 and 12
Other outcomes:
measure: Urinary Distress Inventory (UDI) 6 short form
timeFrame: At week 0, 6 and 12
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Medicine Women's Pelvic Health And Continence Center
state: New York
Study officials:
affiliation: Stony Brook University Hospital, Department of Urology
name: Jason Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.
citation: Finazzi-Agro E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010 Nov;184(5):2001-6. doi: 10.1016/j.juro.2010.06.113. Epub 2010 Sep 20.