Clinical trial NCT03250650: Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment
Official title: Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: Overactive Bladder
Electric Stimulation
Physical Therapy Modalities
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decreasing the numbers of urinary frequency during day and night
timeFrame: 1 month
Secondary outcomes:
measure: Improvement of miccional urgency and urinary urgency incontinence
timeFrame: 2 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Elizabeth A Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Fernanda B Giarreta
role: STUDY_CHAIR
References: