Study Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence

Not Applicable

• Conditions: Urinary Stress Incontinence
• Interventions: Procedure: kinesiotherapy; Procedure: Laser

• Registration Number: NCT03301142
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence

Detailed Description

the objective of this project is to compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence. A randomized controlled clinical trial is proposed involving 40 women diagnosed with stress urinary incontinence randomized into two groups: 1) treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20); 2) treatment with kinesiotherapy for three months with supervision twice a week (n=20). At baseline assessment, patients shall undergo anamnesis, general physical and gynecological exam, assessments of the pelvic floor based on the modified Oxford scale and of the presence of prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system. The following exams shall also be performed: Type 1 urine, urine culture, urodynamic study and 1-hour Pad test. Participants shall complete both the King's Health Questionnaire and Incontinence Quality of Life Questionnaire (IQOL). Post-treatment, patients will be assessed during follow-up visits at 1, 3, 6 and 12 months by physical exam and application of the questionnaires. The Pad test will be re-administered at 6 and 12 months. Data will be grouped and statistically assessed.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07
• Primary Completion: 2018-02
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Post-menopausal women with stress urinary incontinence will be recruited for this study.

Exclusion Criteria

• Patients presenting detrusor hyperactivity,stress urinary incontinence with sphincter deficiency genital prolapse, stages 3 and 4 on the POP-Q system, genital cancer, history of painful bladder syndrome, previous history of radiotherapy, keloid, use of photosensitive drugs, uncontrolled diabetes mellitus, active vaginal infection (bacterial vaginosis and candidiasis), abnormal genital bleeding or vaginal stenosis shall be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
kinesiotherapy	kinesiotherapy	with supervision twice a week for three months (n=20)
Device laser	Laser	treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20

Primary Outcome Measures

Name	Time	Method
Improvement of urinary loss	twelve months	the urinary loss will be evaluated with the pad test

Secondary Outcome Measures

Name	Time	Method
improvement of pelvic floor strength	twelve months	Functional evaluation of the pelvic floor with modified Oxford scale

Trial Locations

Locations (1)

Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).; 🇧🇷 São Paulo, Brazil