Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence (BUTTON)

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Gnankang Sarah Napoe
Updated on 3 March 2022


This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence


Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary

Condition Overactive Bladder Syndrome, Urinary Incontinence, Urge
Treatment PTNS
Clinical Study IdentifierNCT03535857
SponsorGnankang Sarah Napoe
Last Modified on3 March 2022


Yes No Not Sure

Inclusion Criteria

Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy
Patients who consent to participate in the study
Patients on pharmacologic therapy at the time of recruitment can continue their treatment

Exclusion Criteria

Pregnant patients
Patients with pacemakers of implantable defibrillators
Patients with neurogenic bladder
Patients who have received Botox or have an implant for sacral nerve stimulation
Patients with uncontrolled bleeding disorder
Patients with unhealed ulcers or with leg edema surrounding medial malleolus
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