Radiofrequency Non-ablation in the Treatment of Women With Urinary Stress Incontinence: Study Pilot

Phase 1

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Tonederm® (Radiofrequency non ablative)

• Registration Number: NCT02623842
• Lead Sponsor: Centro de Atenção ao Assoalho Pélvico

Brief Summary

Pilot study, case series conducted in women with a clinical diagnosis of urinary incontinence and were treated with radiofrequency technique for capacitive transfer non ablative in external urethral meatus. All participants did an hour Pad Test. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Tonederm® brand device with capacitive transfer method using non-ablative handle with electrode in the region of the external urethral meatro and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration of 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2014-11
• Study Completion: 2015-05
• Status Verified: 2015-11
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-07
• Last Update Submitted: 2015-12-07
• Study First Posted: 2015-12-08
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• The target audience was made up of women aged between 18 and 65 years with a diagnosis of stress urinary incontinence, referred for physical therapy and who had Pad Test positive criteria by International Continence Society

Exclusion Criteria

• Were excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of copper and pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency	Tonederm® (Radiofrequency non ablative)	-

Primary Outcome Measures

Name	Time	Method
Pad test 1 hour (urinary loss)	one week, one month, two month , three month and six month measure the urinary loss	The pad test 1 hour is performed following some standard activities to mention the amount of urinary loss, through an absorbent delivered the patients ... after the completion of the activities the absorbent is heavy.