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

NCT ID: NCT04909047

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Parasacral transcutaneous electrostimulation outpatient

electrostimulation device

Group Type: EXPERIMENTAL

parassacral transcutaneous electrostimulation

Intervention Type: DEVICE

Use of parassacral transcutaneous electrostimulation

transcutaneous tibial electrostimulation outpatient

electrostimulation device

Group Type: EXPERIMENTAL

parassacral transcutaneous electrostimulation

Intervention Type: DEVICE

Use of parassacral transcutaneous electrostimulation

home parasacral electrostimulation

electrostimulation device

Group Type: EXPERIMENTAL

parassacral transcutaneous electrostimulation

Intervention Type: DEVICE

Use of parassacral transcutaneous electrostimulation

Interventions

parassacral transcutaneous electrostimulation

Use of parassacral transcutaneous electrostimulation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Atenção ao Assoalho Pélvico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

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

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

Centro de Atenção ao assoalho pélvico

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Patrícia Lordelo, PhD

Role: CONTACT

pvslordelo@hotmail.com

+5571988592400

Suele Caetano, Specialist

Role: CONTACT

suelecaetano.pos@bahiana.edu.br

+55 73 9187-1843

Facility Contacts

Patricia V Lordelo, Phd

Role: primary

pvslordelo@hotmail.com

+5571988592400

Patrícia Lordelo, PhD

Role: primary

Patricia Lordelo, post doc

Role: primary

pvslordelo@hotmail.com

+5571988592400

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Other Identifiers

Centro AA Pelvico

Identifier Type: -

Identifier Source: org_study_id