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CompletedNCT02623842Updated Dec 8, 2015

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

A Phase 1 interventional study of Tonederm® (Radiofrequency non ablative) in Urinary Incontinence, sponsored by Centro de Atenção ao Assoalho Pélvico. Completed. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-12-08.

Sponsored by Centro de Atenção ao Assoalho Pélvico · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Urinary Incontinence

Keywords

  • urinary incontinence
  • woman
  • radiofrequency
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 10 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Centro de Atenção ao Assoalho Pélvico is the lead sponsor of 17 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Radiofrequency

    Device: Tonederm® (Radiofrequency non ablative)

Interventions

  • DeviceTonederm® (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.

06

What researchers measure

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.

    Time frame: one week, one month, two month , three month and six month measure the urinary loss

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02623842
Lead sponsor
Centro de Atenção ao Assoalho Pélvico
Responsible party
Sponsor
First posted
Dec 8, 2015
Start date
Jul 2013
Primary completion
Nov 2014
Completion
May 2015
Last update
Dec 8, 2015

Study contacts

Patricia V Lordelo, PhD
principal investigator · Centro de Atenção ao Assoalho Pélvico - BAHIANA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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