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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Urinary Stress Incontinence

Treatments: Procedure: kinesiotherapy; Procedure: Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03301142

13341

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Device laser

Experimental group

Description:

treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20

Treatment:

Procedure: Laser

kinesiotherapy

Active Comparator group

Description:

with supervision twice a week for three months (n=20)

Treatment:

Procedure: kinesiotherapy