The Effectiveness of Parassacral Transcutaneous Stimulation Compared to Tibial Transcutaneous Stimulation, Home Protocol and Behavioral Therapy in the Treatment of Female Hyperative Bladder: Randomized Clinical Trial

March 4, 2024 updated by: Centro de Atenção ao Assoalho Pélvico
Introduction: The overactive bladder is a highly prevalent condition, which negatively impacts the quality of life and daily activities of women. Transcutaneous electrostimulation is currently a therapeutic alternative for urinary urgency symptoms. Although it can be applied to the sacral plexus or tibial nerve, the literature shows the effectiveness of these two modalities, in isolation, but there are few scientific studies that compare them as two therapeutic alternatives. Primary objective: to evaluate the efficacy between parascutaneous electrostimulation, tibial transcutaneous stimulation, and home protocol in the treatment of female overactive bladder. Methodology: This is a clinical trial, which will include women with a clinical complaint of overactive bladder, with or without urgency-incontinence, who will be randomized into 3 groups: transcutaneous parasacral electrostimulation (EETP), transcutaneous tibial electrostimulation (EETT) and a third group, home transcutaneous parasacral electrostimulation (EETPD), will consist of women who have financial difficulties or locomotion to attend the clinic.All groups, in the first session, will be guided to conduct behavioral therapy and will receive an educational booklet with guidelines. The equipment to be used will have a wave frequency of 10 Hz, a pulse width of 700 µs and a 20-minute session, with intensities according to the participant's tolerance. The intervention protocol of the EETP group is 30 sessions, three times a week, with an active electrode in the parasacral region. For EETT, 30 sessions will also be held, three times a week, with the electrode active in the tibial region. Participants will be captured at educational events held by the Pelvic Floor Service Center in Salvador and the metropolitan region. Participants will answer the basic anamnesis questionnaires, ICIQ-OAB, ROMA III criteria, Bristol scale, Hospital Anxiety and Depression Scale, Oswestry scale, Pittsburgh sleep quality index and Female Sexual Function Index. Then, the assessment of the bladder neck and the thickness of the bladder wall will be performed by 2D ultrasonography via suprapubic and intravaginal, following the assessment protocol described for the intervention groups. Primary outcomes: clinical improvement of symptoms, urinary frequency, episodes of urgent urinary incontinence, presence of adverse effects and constipation. Secondary outcomes: quality of life, sexual function, quality of sleep, anxiety and depression, muscle function (PERFECT and electromyography), lumbar-pelvic pain (pain intensity) and ultrasound. Participants will be followed for a minimum of 12 months to verify the long-term response, returning every 3 months. Expected results: The outpatient transcutaneous parasacral electrostimulation is expected to be superior when compared to the tibial transcutaneous electrostimulation in the resolution of the symptoms of the overactive female bladder.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Ba
      • Salvador, Ba, Brazil, 40.290-000
        • Recruiting
        • Centro de Atenção ao assoalho pélvico
        • Contact:
    • Bahia
      • Salvador, Bahia, Brazil, 40290000
        • Recruiting
        • Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública
        • Contact:
          • Patrícia Lordelo, PhD
      • Salvador, Bahia, Brazil, 40290000
        • Recruiting
        • Centro de Atenção ao assoalho pélvico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women with symptoms of overactive bladder, aged 18 to 65 years.

Exclusion Criteria:

  • Participants who have difficulty understanding the stages of the research, report cognitive deficit or psychiatric illness, patients with congenital orthopedic / neurological diseases, overactive bladder due to neurological impairment, presence of lower urinary tract infection, sensory deficit in the sacral or tibial region, diagnosis of chronic renal failure, patients with pacemakers and implantable cardioverter defibrillators and pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parasacral transcutaneous electrostimulation outpatient
electrostimulation device
Device: parassacral transcutaneous electrostimulation
Use of parassacral transcutaneous electrostimulation
Experimental: transcutaneous tibial electrostimulation outpatient
electrostimulation device
Device: parassacral transcutaneous electrostimulation
Use of parassacral transcutaneous electrostimulation
Experimental: home parasacral electrostimulation
electrostimulation device
Device: parassacral transcutaneous electrostimulation
Use of parassacral transcutaneous electrostimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of urinary leakage episodes
Time Frame: 90 days
Clinical improvement of symptoms of urinary leakage episodes analyzed by voiding diary, urofluxometry and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
90 days
Reduction in urinary frequency
Time Frame: 90 days
Reduction in the number of daily urination analyzed by voiding diary , urofluxometry, 2 D ultrasonography and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
90 days
Clinical improvement of constipation
Time Frame: 90 days
Effort in bowel movements, stool shape, number of weekly bowel movements analyzed by Rome, Bristol criterion and 2 D ultrasonography
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring quality of life by questionnaire
Time Frame: 90 days
Will be used the King´s Health Questionnaire (KHQ)
90 days
Sexual function
Time Frame: 90 days
Will be used the questionnaire of Female Sexual Function (FSFI)
90 days
Quality of sleep
Time Frame: 90 days
Will be used the Pittsburgh sleep quality index (PSQI)
90 days
Anxiety and depression
Time Frame: 90 days
Scale of the Hospital Anxiety and Depression Scale (HADS)
90 days
Muscle function
Time Frame: 90 days
Analyze through the PERFECT test and by electromyography
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Atenção ao Assoalho Pélvico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Centro AA Pelvico

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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