Study Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence
Primary Purpose
Urinary Stress Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser
kinesiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring urinary stress incontinence, urinary incontinence,stress, laser, physiotherapy, kinesiotherapy
Eligibility Criteria
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.
Sites / Locations
- Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).Recruiting
- Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Device laser
kinesiotherapy
Arm Description
treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20
with supervision twice a week for three months (n=20)
Outcomes
Primary Outcome Measures
Improvement of urinary loss
the urinary loss will be evaluated with the pad test
Secondary Outcome Measures
improvement of pelvic floor strength
Functional evaluation of the pelvic floor with modified Oxford scale
Full Information
NCT ID
NCT03301142
First Posted
August 10, 2016
Last Updated
November 3, 2017
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03301142
Brief Title
Study Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence
Official Title
Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
urinary stress incontinence, urinary incontinence,stress, laser, physiotherapy, kinesiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device laser
Arm Type
Experimental
Arm Description
treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20
Arm Title
kinesiotherapy
Arm Type
Active Comparator
Arm Description
with supervision twice a week for three months (n=20)
Intervention Type
Procedure
Intervention Name(s)
Laser
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
kinesiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of urinary loss
Description
the urinary loss will be evaluated with the pad test
Time Frame
twelve months
Secondary Outcome Measure Information:
Title
improvement of pelvic floor strength
Description
Functional evaluation of the pelvic floor with modified Oxford scale
Time Frame
twelve months
Other Pre-specified Outcome Measures:
Title
impact in the quality of life
Description
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucilia C fonseca
Phone
5511981839348
Email
LUCILIACFONSECA@GMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
JORGE M HADDAD, PHD
Phone
5511930712843
Email
JORGE_MILHEMH@UOL.COM.BR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LUCILIA C FONSECA
Organizational Affiliation
UNIVERSIDADE SÃO PAULO (USP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucilia C Fonseca, DR
Phone
5511981839348
Email
luciliacfonseca@gmail.com
First Name & Middle Initial & Last Name & Degree
FERNANDA BA GIARRETA
First Name & Middle Initial & Last Name & Degree
ELIZABETH A FERREIRA, PHD
First Name & Middle Initial & Last Name & Degree
IVY NARDE, M
Facility Name
Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucilia C Fonseca, DR
Phone
5511981839348
Email
luciliacfonseca@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
3201169
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Study Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence
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