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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03301142

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Stress Incontinence	Procedure: Laser Procedure: kinesiotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study

Actual Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device laser treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20	Procedure: Laser 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.
Active Comparator: kinesiotherapy with supervision twice a week for three months (n=20)	Procedure: kinesiotherapy 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.

Arm

Intervention/Treatment

Experimental: Device laser

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

Procedure: Laser

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.

Active Comparator: kinesiotherapy

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

Procedure: kinesiotherapy

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.

Outcome Measures

Primary Outcome Measures

Improvement of urinary loss [twelve months]
the urinary loss will be evaluated with the pad test

Secondary Outcome Measures

improvement of pelvic floor strength [twelve months]
Functional evaluation of the pelvic floor with modified Oxford scale

Other Outcome Measures

impact in the quality of life [twelve months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).	São Paulo		Brazil	05403-010
2	Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).	São Paulo		Brazil	05403-010