Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2018-06-30

Brief Summary

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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).

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Detailed Description

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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

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

All the questionnaires (OABV-8, King´s Health, Anamnesis), Function Avaliation of Pelvic Floor Muscles, before and after treatment will be conduced by other person who is not the responsable for the research.

Study Groups

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Group 1: 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.

Group Type ACTIVE_COMPARATOR

TTNS

Intervention Type DEVICE

Transcutaneous tibial electric stimulation

Group 2: 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 Type EXPERIMENTAL

ES+TTNS

Intervention Type DEVICE

Transvaginal electric stimulation

Interventions

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TTNS

Transcutaneous tibial electric stimulation

Intervention Type DEVICE

ES+TTNS

Transvaginal electric stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No