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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03742206
Enrollment
68
Registered
2018-11-15
Start date
2018-01-25
Completion date
2019-10-31
Last updated
2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Urinary Urge Incontinence

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.

Interventions

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

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

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of treatment in quality of lifesix weeksApplication 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

MeasureTime frameDescription
Severity of urinary incontinencesix weeksApplication 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).
Severity of overactive bladder symptomssix weeksApplication 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.

Countries

Brazil

Contacts

Primary ContactMallmann
suzana_mallmann@hotmail.com+5551996261820

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026