NCT03250650

Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment

Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female overactive bladder syndrome (OAB).

Detailed description

This is a clinical trial, blind and randomized study with 86 women with OAB or Mixed Urinary Incontinence with prevalence in the OAB symptoms, who were randomly and allocated into 2 equal groups. Group 1 underwent transcutaneous tibial nerve electrical stimulation (TTNS),for 30 minutes using 10Hz for frequency and 200µs for pulse. Group 2 received a combined of Vaginal electrical stimulation (ES) using a transvaginal probe applied ,for 20 minutes using 10Hz for frequency and 1ms for pulse and tibial nerve electrical stimulation, 30 minutes at the same parameters used in Group1. Both groups were treated once a week for 12 sessions. All patients were evaluated before and after treatment by a voiding diary, King´s Health questionnaire, avaliation of pelvic floor muscle function, overactive bladder questionnaire (OABV-8).The analyzed variables included day and night time frequency, urgency and urge incontinence. The sample calculation was based on the difference waited between 2 groups regarding the frequency improvment.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DEVICE	TTNS	Transcutaneous tibial electric stimulation
DEVICE	ES+TTNS	Transvaginal electric stimulation

Timeline

• Start date: 2017-03-09
• Primary completion: 2018-04-30
• Completion: 2018-06-30
• First posted: 2017-08-16
• Last updated: 2019-04-17

Locations

1 site across 1 country: Brazil