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Clinical Trials/NCT02623842
NCT02623842CompletedPhase 1

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

Centro de Atenção ao Assoalho Pélvico0 sites10 target enrollmentStarted: July 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
10
Primary Endpoint
Pad test 1 hour (urinary loss)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Pad test 1 hour (urinary loss)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centro de Atenção ao Assoalho Pélvico
Sponsor Class
Other
Responsible Party
Sponsor

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