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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
Age
18 - 99 years
Sex
FEMALE
Healthy Volunteers
No
Gnankang Sarah Napoe
Pittsburgh, Pennsylvania, United States
WIHRI
Providence, Rhode Island, United States
Start Date
April 17, 2018
Primary Completion Date
September 8, 2023
Completion Date
September 8, 2023
Last Updated
April 15, 2025
36
ACTUAL participants
PTNS
DEVICE
Lead Sponsor
Gnankang Sarah Napoe
NCT05362292
NCT04873037
Data Source & Attribution
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