An interventional study of Laser and kinesiotherapy in Urinary Stress Incontinence, sponsored by University of Sao Paulo General Hospital. Status unknown at 2 sites in Brazil. Open to female participants. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence
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.
Exclusion Criteria:
treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20
Procedure: Laser
with supervision twice a week for three months (n=20)
Procedure: kinesiotherapy
The patients will be submitted to application of the Erbium Laser: YAG(yttrium aluminium garnet) 2940nm, SMOOTH mode developed by FOTONA.The vaginal canal will be accessed using a specific speculum. The 90 degree laser tip shall be used to perform 4 applications to the anterior and lateral vaginal wall at each of the 5 clock points (9,10:30,12,1:30,3 'o´-clock´), commencing at the back of the vagina, retracting in increments of 0.5cm, where 4 shots are made at each interval up to a distance 1cm short of the external opening of the urethra. After completion of this stage, the 90 degree tip shall be switched for the 360 degree tip, whereupon 4 additional applications shall be performed with 4 shots every 0.5 cm along the vaginal trajectory outlined above.
Patients will be guided by the physiotherapist to perform exercises to strengthen the pelvic floor muscles at home on a daily basis in the supine position with an empty bladder. It will be performed 10 repetitions of five-second contractions, the 15 three-second contractions; 20 two seconds contractions; 20 contractions of a second; 5 repetitions of strong contractions while coughing; 10 repetitions of exercise "bridge" associated with pelvic floor contraction and relaxation up in descending.The level of difficulty in performing the exercises will be determined in accordance with the adopted position. In .changes position should be held every four sessions.
Improvement of urinary loss
the urinary loss will be evaluated with the pad test
Time frame: twelve months
improvement of pelvic floor strength
Functional evaluation of the pelvic floor with modified Oxford scale
Time frame: twelve months
impact in the quality of life
the impact in the quality of life will be evaluated with the quality of life questionnaires ( King's Health Questionnaire and IQOL quality of life questionnaires).
Time frame: twelve months
Plan to share: No
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University of Sao Paulo General Hospital