Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

NCT03742206 | Unknown

• 1 other identifier: 17-0056
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women. Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.

Conditions

Overactive Bladder; Urinary Urge Incontinence

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment in quality of life

  Application of the King's Health Questionnaire (KHQ). KHQ is an instrument for measuring quality of life in people diagnosed with urinary incontinence, consisting of 30 objective questions distributed in 9 domains. In each question, values are assigned according to the intensity of the patient's complaint (0 = not applicable, 1 = no; 2 = a little / sometimes, 3 = more or less / several times, 4 = a lot / always). The final score is calculated individually for each domain and ranges from 0 to 100, the highest score being related to a poorer quality of life.

  six weeks

Secondary Outcomes (2)

• Severity of urinary incontinence

  six weeks

• Severity of overactive bladder symptoms

  six weeks

Study Arms (2)

Parasacral

EXPERIMENTAL

Parasacral Transcutaneous Electrical Stimulation Group: participants in this group will receive two self-adhesive electrodes and will be instructed to position them in the sacral region. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks.

Device: Parasacral Transcutaneous Electrical Stimulation

Posterior Tibial Nerve

ACTIVE COMPARATOR

Transcutaneous Posterior Tibial Nerve Stimulation Group: participants in this group will receive a neoprene ankle brace that will be connected to the electrostimulator. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks.

Device: Transcutaneous Posterior Tibial Nerve Stimulation

Interventions

Parasacral Transcutaneous Electrical Stimulation DEVICE

Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.

Parasacral

Transcutaneous Posterior Tibial Nerve Stimulation DEVICE

Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation

Posterior Tibial Nerve

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of overactive bladder with or without the presence of urinary incontinence.
• Understand the instruments used in the research.

You may not qualify if:

• Urinary tract infection
• Neurological disease
• Other previous treatment in the last four weeks

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Suzana Mallmann

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

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; Urinary Incontinence; Urination Disorders

Study Officials

• José Geraldo Lopes Ramos

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mallmann

CONTACT

+5551996261820; suzana_mallmann@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 15, 2018
• Study Start: January 25, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 15, 2018

Record last verified: 2018-10

Locations

BR (1)