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Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

Not Applicable
Conditions
Overactive Bladder
Urinary Urge Incontinence
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.

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
Primary Outcome Measures
NameTimeMethod
Efficacy of treatment in quality of lifesix 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
NameTimeMethod
Severity of overactive bladder symptomssix 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 incontinencesix 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

Suzana Mallmann
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Mallmann
Contact
+5551996261820
suzana_mallmann@hotmail.com
José Geraldo Lopes Ramos
Principal Investigator

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