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Completed

NCT Number: NCT03250650

Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment

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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Key information

Conditions

Overactive Bladder Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de São Paulo

São Paulo, 55, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTNS

Device

Transcutaneous tibial electric stimulation

ES+TTNS

Device

Transvaginal electric stimulation

Primary outcomes

  1. Decreasing the numbers of urinary frequency during day and night

    Time frame: 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 outcomes

  1. Improvement of miccional urgency and urinary urgency incontinence

    Time frame: 2 months

    We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Acronym: OAB

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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