The main purpose of this study was to compare the effect of pelvic floor muscle exercises and vibration therapy in control of SUI. The study is an assessor blind randomized clinical parallel group trial which is approved by the Ethical Committee of Tehran University of Medical Sciences and each subject will sign informed written consent. The patients with stress incontinence that fulfill the inclusion criteria will be examined by gynecologist and after that will be introduced to sports medicine clinics. Participants will be randomly allocated in two treatment groups; vibration therapy (WBVT) and exercise therapy (ET). Participants will be familiarized with testing procedures at the first session and also the research questionnaire and IQOL questionnaire will be completed .The pelvic floor muscle contraction will be tested and graded according to the modified Oxford grading system, also pelvic floor muscle dynamic and static endurance tests will be evaluated. All subjects in ET group will follow a definite exercise therapy program under supervision for 4 weeks. The WBVT group will do exercises on vibration platform (Powerplate, USA) for 4 weeks. Subjects will be evaluated pre and post interventions for outcomes (decreasing of UI symptoms, increasing pelvic floor muscle strengths and endurance, quality of their life
General information
Acronym
WBVT & Exercise therapy - SUI
IRCT registration information
IRCT registration number:IRCT201012285486N1
Registration date:2012-01-28, 1390/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-28, 1390/11/08
Registrant information
Name
Azar Moezy
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
moeziazr@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of whole body vibration training and exercise therapy in treating females stress urinary incontinence
Public title
A comparative study of whole body vibration training and exercise therapy in treating females stress urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the development of genuine stress incontinence based on patient history, medical examination, a cotton-swab test urine culture; not being pregnant, breast feeding and menopause; age between 35 to 50 years; no history of exercise therapy for SUI in past 3 months; lack of neurological diseases such as MS, CVA, Spina bifida; no risk factor for pelvic visceral prolapse and outlet obstruction and detrusor instability; no high residual urine volume; no outlet obstruction and chronic constipation; lack of chronic disease, chronic respiratory disease; no contraindications for Vibration therapy and exercise therapy; no history of surgical treatment for incontinence; no history of pelvic cancers; no history of taking drugs that affect the urine; an read and write;
Exclusion criteria: unwillingness of the patient for continuing the treatment sessions; pregnancy and diseases that may impede participation in the study; absence of patients in treatment sessions and genital and urinary infection;
Age
From 35 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of vice chancellor for research ,Tehran University of Medical Sciences
Street address
Keshavarz Bluv
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
8521 مورخ 22/10/89
Health conditions studied
1
Description of health condition studied
Stress Urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
Primary outcomes
1
Description
Urinary Incontinence
Timepoint
Before and after the intervention
Method of measurement
Assesment and examination
2
Description
IQOL Questionnaire
Timepoint
Before and after the intervention
Method of measurement
IQOL Questionnaire score
Secondary outcomes
1
Description
Pelvic floor muscle strength
Timepoint
Before and after the intervention
Method of measurement
The pelvic floor muscle strength and endurance with Manual Muscle Testing and completed questionnair
Intervention groups
1
Description
Pelvic floor muscles strengthening exercises in the exercise therapy group
Category
Rehabilitation
2
Description
Whole body vibration training in WBVT group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabady hospital and Hazrat rasol akram hospital ,sport medicine clinic
Full name of responsible person
Dr azizeh farzinmehr
Street address
Neyaesh Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Tehran university of medical sciences
Full name of responsible person
Ms Alamdar
Street address
Keshvarz Bluv
City
Tehran
Grant name
معاونت پژوهشی دانشگاه علوم پزشکی تهران
Grant code / Reference number
90-01-30-12331
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Tehran university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Azar Moezy
Position
PhD - assistant prof.
Other areas of specialty/work
Street address
Sports Medicine department -Medical School- Tehran university of medical sceinces -Hemat Highway -
City
Tehran
Postal code
Phone
+98 21 8294 3424
Fax
Email
Moeziazr@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
TUMS
Full name of responsible person
Dr Azar Moezy
Position
phD
Other areas of specialty/work
Street address
Sports Medicine department -Medical School- Tehran university of medical sceinces -Hemat Highway
City
Tehran
Postal code
Phone
+98 21 8294 3424
Fax
Email
moeziazr@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)