Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

Comparison of Parasacral Transcutaneous Electrical Stimulation With Transcutaneous Posterior Tibial Nerve Stimulation in Women With Overactive Bladder: a Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder; Urinary Urge Incontinence
• Intervention / Treatment: Device: Parasacral Transcutaneous Electrical Stimulation; Device: Transcutaneous Posterior Tibial Nerve Stimulation

Detailed Description

Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed

Main outcome: to measure changes in urinary urgency and quality of life.

Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Recruiting
      • Suzana Mallmann
      • Contact: Mallmann; Phone Number: +5551996261820; Email: suzana_mallmann@hotmail.com
      • Principal Investigator: José Geraldo Lopes Ramos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parasacral; 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; Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.
Active Comparator: Posterior Tibial Nerve; 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; Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of urinary incontinence	Application of the Incontinence Severity Index. It is a brief instrument, consisting of two questions regarding the frequency and amount of urinary loss. The final score obtained by multiplying the frequency scores by the amount of urinary loss allows the incontinence urinary to be classified as mild (final score 1-2), moderate (final score 3-6 ), severe (final score 8-9) and very severe (final score 12).	six weeks
Severity of overactive bladder symptoms	Application of the Symptom Bother Scale. It instrument asks how bothered the patient is by the 4 hallmark symptoms of overactive bladder: urinary frequency, urgency, nocturia, and urge incontinence. Patients respond on a 6-point Likert scale ranging from 0 (not at all) to 5 (a very great deal), with a maximum possible score of 40, calculated by adding all responses.	six weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Jose Geraldo Lopes Ramos, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: 17-0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No