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Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

H

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

Urinary Urge Incontinence
Overactive Bladder

Treatments

Device: Transcutaneous Posterior Tibial Nerve Stimulation
Device: Parasacral Transcutaneous Electrical Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03742206
17-0056

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 2 patient groups

Parasacral
Experimental group
Description:
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.
Treatment:
Device: Parasacral Transcutaneous Electrical Stimulation
Posterior Tibial Nerve
Active Comparator group
Description:
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.
Treatment:
Device: Transcutaneous Posterior Tibial Nerve Stimulation

Trial contacts and locations

1

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Central trial contact

Mallmann

Data sourced from clinicaltrials.gov

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