Electrostimulation in the Treatment of Idiopathic Overactive Bladder

NCT ID: NCT03519126

Last Updated: 2020-12-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-19
• Study Completion Date: 2020-03-30

Brief Summary

This is a clinical trial whose objective is to compare the efficacy of transcutaneous electrostimulation of the posterior tibial nerve with intravaginal electrostimulation in the treatment of women with symptoms of idiopathic overactive bladder. The volunteers will be randomly randomized into three study groups: posterior tibial group, vaginal group and control group. They are evaluated at three times: before the start of treatment, at the end of 6 weeks of treatment and after 1 month (follow up). The evaluation will occur through a voiding diary and a quality of life questionnaire. For the treatment groups will be used depolarized biphasic current with frequency of 10 Hz and pulse width of 200 μs, and intensity according to the tolerance of the patient. The hypothesis of the study is that the two forms of electrostimulation for treatment of idiopathic overactive bladder will be effective, but transcutaneous electrostimulation of the posterior tibial nerve will be more effective than intravaginal.

Detailed Description

Objective: To compare the efficacy between intravaginal and transcutaneous electrostimulation of the posterior tibial nerve in the treatment of women with symptoms of idiopathic overactive bladder or mixed urinary incontinence.

METHODS: This is a randomized, controlled, single-blind clinical trial with comparative analysis between study groups and a control, performed at three moments: pre and post clinical intervention and one month after the end of treatment. Vaginal electrostimulation group (GV), transcutaneous electrostimulation group of the posterior tibial nerve (GTP) and control group (CG - without intervention). The intervention groups will be treated with biphasic current with a frequency of 10 Hz and a pulse width of 200 μs for 12 sessions of 30 minutes each. Participants will be evaluated and reevaluated by means of a general data questionnaire, 3-day urinary diary and an International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Statistical analysis will be performed using SPSS version 22 and the level of significance adopted will be p <0.05.

Conditions

Urinary Bladder, Overactive

Keywords

Urinary Bladder, Overactive; Electric Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

vaginal

Group of volunteers who will be treated with vaginal electrostimulation

Group Type: EXPERIMENTAL

electrostimulation

Intervention Type: OTHER

Electrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs.

posterior tibial nerve

Group treated with transcutaneous electrostimulation of the posterior tibial nerve

Group Type: EXPERIMENTAL

electrostimulation

Intervention Type: OTHER

Electrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs.

control

Group of volunteers who will not be treated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

electrostimulation

Electrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women
• aged 18 years and over
• literate
• exhibit symptoms of overactive bladder (urinary urgency, urge incontinence, nocturia and polaciuria) or mixed urinary incontinence with predominance of urge incontinence
• to present lower urinary tract dysfunction identified by scores that were equal or higher than 8 points in the Overactive Blader version 8 questionnaire (OAB-V8)
• accept to participate in the study by means of signing the Term of Free and Informed Consent approved by the Research Ethics Committee of the University Hospital of the Northern Region of Paraná State University of Londrina (HURNP / UEL).

Exclusion Criteria

• Women who are virgin
• pregnant
• have a recurrent lower urinary tract infection (more than three episodes a year)
• vaginal infection
• history of overactive bladder medication in the last three months
• urinary incontinence to efforts exclusively
• previous surgery to treat incontinence urinary
• neurological diseases (such as multiple sclerosis, Alzheimer's disease, stroke, Parkinson's disease)
• current history of genitourinary neoplasia
• genital prolapse above third degree of Baden and Walker
• decompensated diabetic
• patients with cardiac pacemaker
• metal implant in the ankle and right foot
• cognitive deficit that inability to respond to questionnaires properly and / or correctly fill in the voiding diary
• do not perform all treatment sessions

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Janaina Mayer de Oliveira Nunes

OTHER

Sponsor Role: lead

Responsible Party

Janaina Mayer de Oliveira Nunes

Master

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Overactive bladder

Identifier Type: -

Identifier Source: org_study_id