NCT07366918

Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (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 IVES vs perineal ES in women with idiopathic OAB. The main questions aimed to be answered are: Is Intravaginal Electrical Stimulation (IVES) or perineal ES more effective on clinical parameters related to incontinence and quality of life in women with idiopathic overactive bladder (OAB)? Participants (n:63) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 3 groups using a randomization table. The first group will receive IVES and bladder training (n:21), second group will receive perineal ES and bladder training (n:21) and third group will receive bladder training (n=21) . Measurements will be performed twice in total, before and at the end of treatment (8th week).

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
OTHER	Bladder Training + Intravaginal ES	IVES will be performed in the lithotomy position using a vaginal probe and a stimulation device . IVES will be performed three days a week for 20 minutes per day for 8 weeks, totaling 24 sessions. Stimulation parameters will be a frequency of 10 Hz, a 5-10 second work-rest cycle, and a 100 ms pulse width. A symmetrical biphasic pulse wave can be delivered in the range of 1-100 mA (based on the patient's discomfort level feedback).
OTHER	BT	A written brochure will then be provided as a program that can be implemented at home. In the first stage, women will be informed about the location of the BT, pelvic anatomy, and pathophysiology. Following this informational session, they will be demonstrated how to squeeze the BT at least once using digital palpation techniques to suppress urgency. In the second stage, which includes urgency suppression strategies, the aim is to delay urination, inhibit detrusor contraction, and prevent urgency by squeezing the BT several times in a row, taking deep breaths, focusing on another task for a while, and self-motivating themselves. In the third stage, a timed voiding program will be initiated. This will be carried out in two steps: timed voiding and increasing the time between voids by keeping a voiding diary. In the final stage, women will be encouraged to continue BT
OTHER	Bladder Training + Perineal ES	Perineal ES will be administered in the lithotomy position using a combined electrotherapy stimulation device with surface electrodes. Perineal ES will be administered 20 minutes per day, 3 days per week, for 8 weeks, for a total of 24 sessions. Stimulation parameters will be 10 Hz frequency, 5-10 s work-rest cycle, and 100 µs pulse width. A symmetrical biphasic current wave can be delivered in the 1-100 mA range (depending on the patient's discomfort level feedback). In this application, five 2 cm diameter surface electrodes will be used: four electrodes symmetrically in the perianal region and one electrode (ground-neutral electrode) on the leg. Patients will not perform voluntary contractions during ES. Surface electrodes will be used individually for each patient. Perineal ES sessions will be performed by a physical medicine and rehabilitation physician.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Turkey (Türkiye)