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

NCT04909047 | Recruiting DMC

• 1 other identifier: Centro AA Pelvico
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Transcutaneous Electrical Nerve Stimulation; Urgent Urinary Incontinence; Bladder Hyperactive; Women

Outcome Measures

Primary Outcomes (3)

• Reduction of urinary leakage episodes

  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

  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

  Effort in bowel movements, stool shape, number of weekly bowel movements analyzed by Rome, Bristol criterion and 2 D ultrasonography

  90 days

Secondary Outcomes (5)

• Measuring quality of life by questionnaire

  90 days

• Sexual function

  90 days

• Quality of sleep

  90 days

• Anxiety and depression

  90 days

• Muscle function

  90 days

Study Arms (3)

Parasacral transcutaneous electrostimulation outpatient

EXPERIMENTAL

electrostimulation device

Device: parassacral transcutaneous electrostimulation

transcutaneous tibial electrostimulation outpatient

EXPERIMENTAL

electrostimulation device

Device: parassacral transcutaneous electrostimulation

home parasacral electrostimulation

EXPERIMENTAL

electrostimulation device

Device: parassacral transcutaneous electrostimulation

Interventions

parassacral transcutaneous electrostimulation DEVICE

Use of parassacral transcutaneous electrostimulation

Parasacral transcutaneous electrostimulation outpatient; home parasacral electrostimulation; transcutaneous tibial electrostimulation outpatient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (3)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública

Salvador, Estado de Bahia, 40290000, Brazil

RECRUITING

Centro de Atenção ao assoalho pélvico

Salvador, Estado de Bahia, 40290000, Brazil

RECRUITING

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MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Patrícia Lordelo, PhD

CONTACT

+5571988592400; pvslordelo@hotmail.com

Suele Caetano, Specialist

CONTACT

+55 73 9187-1843; suelecaetano.pos@bahiana.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 1, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

BR (3)