Condensed Percutaneous Tibial Nerve Stimulation (PTNS) Protocol

Stony Brook University

Status: Terminated

Conditions: Overactive Bladder Syndrome

Treatments: Device: percutaneous tibial nerve stimulation (PTNS); Device: Sham procedure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03559946

1180838

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Standard Protocol (SP) group

Sham Comparator group

Description:

The patients in the SP group will receive one PTNS treatment and one sham treatment per week for 12 weeks

Treatment:

Device: percutaneous tibial nerve stimulation (PTNS)

Device: Sham procedure

Condensed Protocol (CP) group

Experimental group

Description:

The patients in the CP group will receive 2 PTNS treatments per week for 12 weeks.

Treatment:

Device: percutaneous tibial nerve stimulation (PTNS)