NCT06390488

Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder

Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pamukkale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB. The main questions aimed to be answered are: What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
OTHER	Transcutaneous medial plantar nerve stimulation (T-MPNS)	T-MPNS will be conducted unilaterally in the supine position using the electrotherapy device with surface electrodes. Two round self-adhesive electrodes will be positioned, with the negative electrode near the metatarsal-phalangeal joint of the great toe on the medial aspect of the foot and the positive electrode approximately 2 cm inferior-posterior to the medial malleolus (in front of the Medio-Malleolar-Calcaneal axis). Channel 1 will provide active stimulation, while channel 2 will remain inactive.
OTHER	Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)	Sham T-MPNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the T-MPNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.

Timeline

• Start date: 2024-11-28
• Primary completion: 2025-01-31
• Completion: 2025-02-28
• First posted: 2024-04-30
• Last updated: 2024-12-02

Locations

1 site across 1 country: Turkey (Türkiye)