Electrostimulation in the Treatment of Idiopathic Overactive Bladder

NCT03519126 | Terminated DMC

• 1 other identifier: Overactive bladder
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Bladder, Overactive

Keywords

Urinary Bladder, Overactive; Electric Stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline miccional emergency at 6 weeks after starting treatment and at 1 month after the end of treatment.

  Sudden and uncontrollable desire to urinate checked through the voiding diary.

  Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.

Secondary Outcomes (4)

• Change from baseline urinary frequency at 6 weeks after starting treatment and at 1 month after the end of treatment.

  Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.

• Change from baseline nocturia at 6 weeks after starting treatment and at 1 month after the end of treatment.

  Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.

• Change from baseline urge-incontinence at 6 weeks after starting treatment and at 1 month after the end of treatment.

  Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.

• Change from baseline quality of life related to the symptoms of overactive bladder at 6 weeks after starting treatment and at 1 month after the end of treatment.

  Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.

Study Arms (3)

vaginal

EXPERIMENTAL

Group of volunteers who will be treated with vaginal electrostimulation

Other: electrostimulation

posterior tibial nerve

EXPERIMENTAL

Group treated with transcutaneous electrostimulation of the posterior tibial nerve

Other: electrostimulation

control

NO INTERVENTION

Group of volunteers who will not be treated

Interventions

electrostimulation OTHER

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

posterior tibial nerve; vaginal

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: age greater than or equal to 18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Janaina Mayer de Oliveira Nunes: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master

Model Details: It is a randomized, controlled, simple blind trial with comparative analysis between study groups and a control, performed in three moments: pre and post clinical intervention and one month after the end of treatment (follow up).

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 8, 2018
• Study Start: April 19, 2016
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share