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

NCT02623842 | Completed Phase 1

• 1 other identifier: U1111-1166-4522
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; woman; radiofrequency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Radiofrequency

EXPERIMENTAL

Device: Tonederm® (Radiofrequency non ablative)

Interventions

Tonederm® (Radiofrequency non ablative) DEVICE

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.

Radiofrequency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia V Lordelo, PhD

  Centro de Atenção ao Assoalho Pélvico - BAHIANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 8, 2015
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-11