Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder Syndrome
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Decreasing the numbers of urinary frequency during day and night
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Elizabeth Alves Gonçalves Ferreira
Professor, PhD
University of Sao Paulo General Hospital
Eligibility Criteria
Inclusion Criteria
- •Women diagnosed with Overactive Bladder Syndrom no neurogenic or Mixed Incontinence Urinary with overactive bladder´s predominance symptoms more than 6 months.
- •Over 18 years old.
- •Normal cognitive level to understand the orientations during the treatment.
Exclusion Criteria
- •Stress Urinary Incontinence
- •Drugs treatment for overactive bladder
- •Pregnant women
- •Neurologic diseases
- •Urinary infecction
- •Cystocele, rectocele and uterine prolapse
- •Infectious contagious diseases
- •Metal implants on the hip or lower members
- •Cardiac pacemaker
- •Bladder tumor
Outcomes
Primary Outcomes
Decreasing the numbers of urinary frequency during day and night
Time Frame: 1 month
We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.
Secondary Outcomes
- Improvement of miccional urgency and urinary urgency incontinence(2 months)