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

Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909047
• Other study ID #: Centro AA Pelvico
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: Patrícia Lordelo, PhD
• Phone: +5571988592400
• Email: pvslordelo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transcutaneous Electrical Nerve Stimulation
• Urgent Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Women

Intervention

Device:
• parassacral transcutaneous electrostimulation
Use of parassacral transcutaneous electrostimulation

Locations

Country	Name	City	State
Brazil	Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública	Salvador	Bahia
Brazil	Centro de Atenção ao Assoalho Pelvico	Salvador	Ba
Brazil	Centro de Atenção ao assoalho pélvico	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico

Country where clinical trial is conducted

Brazil, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

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