Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises

Status Unknown status

Clinical Trial Summary

Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women's lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency.

The overactive bladder present in urge incontinence and mixed cause significant impacts on people's lives and has a prevalence of 16.5% in the US population.

Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment. Drug therapy using drugs which are not specific for the bladder and are associated with many unwanted systemic side effects.

The results obtained by researchers in several countries using conservative techniques in the treatment of patients with urinary incontinence are encouraging and this study aims to evaluate carefully and systematically the effectiveness of tibial stimulation technique.

Importantly, also, that conservative techniques have lower cost than the surgical treatment and have virtually no side effects as most of the drugs used in the pharmacological treatment of female urinary incontinence.

Clinical Trial Description

Goal

Development of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using tibial stimulation and pelvic floor exercises.

Secondary objectives

- Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point).

- Comparison of the effectiveness of tibial stimulation techniques and pelvic floor exercises in the treatment of overactive bladder and urgency / mixed incontinence.

Design Randomized Clinical Trial

Sample Women over the age of 18, complaining of urinary incontinence Urgency or Mixed (with main urgency component), catered in Urogynecology Ambulatory of Hospital de Clinicas de Porto Alegre. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02452593
Study type	Interventional
Source	Federal University of Rio Grande do Sul
Contact	Magda Ms Aranchipe, Master
Email	mchipe@hotmail.com
Status	Unknown status
Phase	N/A
Start date	January 2014
Completion date	August 2015

View Details

See also
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Completed	`NCT04470765` - Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence	N/A
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Active, not recruiting	`NCT05241379` - AURA-2: Augmenting Urinary Reflex Activity	N/A
Completed	`NCT02657057` - Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB	N/A
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Terminated	`NCT03687164` - Group Medical Visits for Latina Women With Urgency Urinary Incontinence	N/A
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Completed	`NCT00337558` - A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)	Phase 4
Completed	`NCT03180372` - Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence	N/A
Completed	`NCT05783219` - Lidocaine Patches Prior to Percutaneous Nerve Evaluation	Phase 2
Active, not recruiting	`NCT05308979` - Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial	Phase 4
Completed	`NCT03672461` - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women	N/A
Completed	`NCT01391780` - Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence	N/A
Completed	`NCT03655054` - eCoin for OAB Feasibility Follow-on Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms