Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

Not Applicable

• Conditions: Overactive Bladder; Urinary Urge Incontinence
• Interventions: Device: Parasacral Transcutaneous Electrical Stimulation; Device: Transcutaneous Posterior Tibial Nerve Stimulation

• Registration Number: NCT03742206
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

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 Timeline

• Study Start: 2018-01-25
• Status Verified: 2018-10
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-12
• Last Update Submitted: 2018-11-12
• Study First Posted: 2018-11-15
• Last Update Posted: 2018-11-15
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parasacral	Parasacral Transcutaneous Electrical Stimulation	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.
Posterior Tibial Nerve	Transcutaneous Posterior Tibial Nerve Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment in quality of life	six weeks	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.

Secondary Outcome Measures

Name	Time	Method
Severity of overactive bladder symptoms	six weeks	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.
Severity of urinary incontinence	six weeks	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).

Trial Locations

Locations (1)

Suzana Mallmann; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil