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

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623842
• Other study ID #: U1111-1166-4522
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2015
• Last updated: December 7, 2015
• Start date: July 2013
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Tonederm® (Radiofrequency non ablative)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pad test 1 hour (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.	one week, one month, two month , three month and six month measure the urinary loss	No