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Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03250650
Acronym
OAB
Enrollment
86
Registered
2017-08-16
Start date
2017-03-09
Completion date
2018-06-30
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome

Keywords

Overactive Bladder, Electric Stimulation, Physical Therapy Modalities

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.

Interventions

DEVICETTNS

Transcutaneous tibial electric stimulation

DEVICEES+TTNS

Transvaginal electric stimulation

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decreasing the numbers of urinary frequency during day and night1 monthWe expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.

Secondary

MeasureTime frameDescription
Improvement of miccional urgency and urinary urgency incontinence2 monthsWe expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026