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

Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Age Range:18 - 99
Start Date:April 17, 2018
End Date:December 31, 2020
Contact:G. Sarah Napoe, MD

Use our guide to learn which trials are right for you!

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

Inclusion Criteria:

1. Female patients over the age of 18 who have previously tried and failed, or were
unable to tolerate, behavioral therapy

2. Patients who consent to participate in the study

3. Patients on pharmacologic therapy at the time of recruitment can continue their

Exclusion Criteria:

1. Pregnant patients

2. Patients with pacemakers of implantable defibrillators

3. Patients with neurogenic bladder

4. Patients who have received Botox or have an implant for sacral nerve stimulation

5. Patients with uncontrolled bleeding disorder

6. Patients with unhealed ulcers or with leg edema surrounding medial malleolus
We found this trial at
101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Phone: 401-453-7560
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
Providence, RI
Click here to add this to my saved trials