Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment

Study 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.

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

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Device: TTNS
* Device: ES+TTNS


Participation Criteria
=================
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 Vaginal infecction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: TTNS<br>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. | Device: TTNS<br>* Transcutaneous tibial electric stimulation<br>|
| Experimental: Group 2: ES + TTNS<br>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. | Device: ES+TTNS<br>* Transvaginal electric stimulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreasing the numbers of urinary frequency during day and night | We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of miccional urgency and urinary urgency incontinence | We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, Electric Stimulation, Physical Therapy Modalities