NCT02657057

Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB

Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Instituto Médico Tecnológico SL · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.

Detailed description

Both therapies have been proven to be effective, but very few times have been compared. PTNS and TENS SNS have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. Only PTNS has shown changes in urodynamic data while undergoing therapy. The investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the TENS group, if we compare both therapies in a randomized control trial. Secondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at TBS scale, while undergoing these therapies.

Conditions

• Overactive Bladder
• Urge Incontinence
• Overactive Detrusor

Interventions

Type	Name	Description
DEVICE	PTNS	The needle and electrode are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.
DEVICE	TENS SNS	Electrodes are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2016-01-15
• Last updated: 2017-08-21

Locations

1 site across 1 country: Spain