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

C

Centro de Atenção ao Assoalho Pélvico

Status and phase

Completed
Phase 1

Conditions

Urinary Incontinence

Treatments

Device: Tonederm® (Radiofrequency non ablative)

Study type

Interventional

Funder types

Other

Identifiers

NCT02623842
U1111-1166-4522

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Radiofrequency
Experimental group
Treatment:
Device: Tonederm® (Radiofrequency non ablative)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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