NCT02747849

Hand & Foot Nocturnal Enuresis TENS Study

Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Rajeev Chaudhry · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the TENS device on the hand and foot as a control.

Detailed description

Nocturnal enuresis is a common problem in children which can have a dramatic psychological and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of peripheral tibial nerve branches has been shown to produce a prolonged inhibition of micturition reflex contractions and significantly increase bladder capacity. The investigators primary goal was to evaluate the effect of foot stimulation on the frequency of nocturnal enuresis episodes in children.

Conditions

• Bedwetting

Interventions

Type	Name	Description
DEVICE	TENS	Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2016-04-22
• Last updated: 2023-04-21
• Results posted: 2023-04-21

Locations

1 site across 1 country: United States