Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment
- Conditions
- Overactive Bladder Syndrome
- Interventions
- Device: ES+TTNSDevice: TTNS
- Registration Number
- NCT03250650
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 86
- 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.
- 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
- Vaginal infecction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: ES + TTNS ES+TTNS Intervention for Group 2: transvaginal electric stimulation plus transcutaneous tibial nerve electric stimulation (ES + TTNS), using a Device Dualpex 961(Quark medical), with transvaginal electrode, located inside the vagina. Once a week for 12 weeks. The parameters used on device were 1milisecond for pulse time and 10Hz for Frequency, during 20 minutes. After transvaginal stimulation, the tibial stimulation will be applied like described on Group 1. Group 1: TTNS TTNS Intervention for Group 1: transcutaneous tibial nerve electric stimulation (TTNS), using a Device Dualpex 961(Quark medical), with 2 silicone electrode in the tibial nerve path, being one on the lower border of the medial malleolus and another one, 10cm above. Once a week for 12 weeks. The parameters used on device were, 200 microseconds for pulse time and 10Hz for Frequency, during 30 minutes.
- Primary Outcome Measures
Name Time Method Decreasing the numbers of urinary frequency during day and night 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 Outcome Measures
Name Time Method Improvement of miccional urgency and urinary urgency incontinence 2 months We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.
Trial Locations
- Locations (1)
Universidade de São Paulo
🇧🇷Sao Paulo, São Paulo, Brazil