Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome

NCT01912885 | Completed

• 1 other identifier: MunickP
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society as urgency, with or without incontinence, usually with increased urinary frequency and nocturia. It is difficult to estimate the prevalence of this syndrome because many patients do not seek medical help, despite considerable negative impact on quality of life. Lower urinary tract dysfunctions can be treated using electrical stimulation of the posterior tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary frequency and nocturia . Due to lack of consensus on the parameters of this technique, further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will accept up to 145 women with overactive bladder diagnosis for at least six months prior to the beginning of the study. The subjects will be divided into five groups: group TENS 0-1 (placebo group), group TENS 1-1 (electrical stimulation of one leg once a week), group TENS 1-2 (electrical stimulation of one leg twice a week), group TENS 2-1 (electrical stimulation of two legs one a week) and group TENS 2-2 (electrical stimulation of two legs twice a week). Physical evaluation will be done at the beginning and at the end of the treatment. Evaluation will be done using the King "s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for follow-up treatment.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in urinary frequence in 12 sessions.

  Number of micturitions per day.

  The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.

Secondary Outcomes (3)

• Change in Nocturia in 12 sessions.

  The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.

• Change in urinary urgence in 12 sessions.

  The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.

• Change in urinary urge-incontinence in 12 sessions.

  The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.

Study Arms (5)

Group TENS 0-1

PLACEBO COMPARATOR

Electrodes will be fixated to one leg and sessions will be held once a week.

Device: TENS 0-1

Group TENS 1-1

EXPERIMENTAL

Electrical stimulation of the posterior tibial nerve of one leg once a week.

Device: TENS 1-1

Group TENS 1-2

EXPERIMENTAL

Electrical stimulation of the posterior tibial nerve of one leg twice a week.

Device: TENS 1-2

Group TENS 2-1

EXPERIMENTAL

Electrical stimulation of the posterior tibial nerve of two legs once a week.

Device: TENS 2-1

Group TENS 2-2

EXPERIMENTAL

Electrical stimulation of the posterior tibial nerve of two legs twice a week.

Device: TENS 2-2

Interventions

TENS 1-1 DEVICE

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg once a week.

Group TENS 1-1

TENS 1-2 DEVICE

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg twice a week.

Group TENS 1-2

TENS 2-1 DEVICE

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs once a week.

Group TENS 2-1

TENS 2-2 DEVICE

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs twice a week.

Group TENS 2-2

TENS 0-1 DEVICE

Placebo: application os electrodes of Transcutaneous Electrical Nerve Stimulation on one leg once a week, without turning on the device.

Group TENS 0-1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with 18 years of age or more;
• Cognitive level adequate for understanding orientations during treatment;
• Clinical diagnosis of overactive bladder syndrome for at least six months prior to the study.

You may not qualify if:

• Pregnant women or women who wish to get pregnant;
• Neurological disease;
• Urinary infection;
• Nephrolithiasis;
• Stress urinary incontinence;
• Mixed urinary incontinence;
• Women in pharmacological treatment for overactive bladder syndrome;
• Women undergoing hormone replacement therapy in the last six months;
• Peripheral neuropathy;
• Cystocele stage two or higher.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Gynecology Ambulatory of the General Hospital of the Faculty of Medicine of the University of Sao Paulo

São Paulo, 05403000, Brazil

Location

Related Publications (1)

• Pierre ML, Friso B, Casarotto RA, Haddad JM, Baracat EC, Ferreira EAG. Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment. Clinics (Sao Paulo). 2021 Aug 16;76:e3039. doi: 10.6061/clinics/2021/e3039. eCollection 2021.

  PMID: 34406271 DERIVED

Study Officials

• Elizabeth AG Ferreira, PhD

  Faculty of Medicine, University of São Paulo, São Paulo, Brazil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: July 31, 2013
• Study Start: October 9, 2013
• Primary Completion: August 25, 2014
• Study Completion: September 25, 2014
• Last Updated: February 15, 2019

Record last verified: 2017-12

Locations

BR (1)