Aim: this study evaluated the effects of pelvic floor muscle exercise on quality of life outcomes in women with stress urinary incontinence. Method: After baseline evaluation, 50 women were assigned to this clinical trial. Women were eligible for the study if they weren’t pregnant, menopause or in postpartum period. Participants were trained to do pelvic floor muscle exercises for 3 months and their quality of life were measured before and 3 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903024002N1
Registration date:2009-02-03, 1387/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-02-03, 1387/11/15
Registrant information
Name
Shadab Shahali
Name of organization / entity
Academic centre of education, culture and research (ACECR), Iran University of medical sciences bran
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 7403
Email address
shahali@irmed.org
Recruitment status
Recruitment complete
Funding source
Academic centre of education, culture and research (ACECR), Iran University of medical sciences branch
Expected recruitment start date
2009-02-03, 1387/11/15
Expected recruitment end date
2009-11-06, 1388/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pelvic floor muscle exercises on quality of life outcomes in women with stress urinary incontinence: a clinical trial study
Public title
Effects of pelvic floor muscle exercises on quality of life outcomes in women with stress urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with stress urinary incontinence. Exclusion criteria: pregnancy; women who were menopause or in postpartum period; women who had medical history including pelvic cancer, severe endometriosis, neurological or metabolic disorders with bladder or sphincter dysfunction; medical or surgical treatment for stress urinary incontinence or vaginal wall prolapse; atrophic vaginitis; vulvoviginitis or urinary tract infection.
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Academic centre of education, culture and research (ACECR), Iran University of medical sciences bran
Street address
No. 94, Beginning of South Gandhi St, Vanak Square
City
Tehran
Postal code
Approval date
2009-05-01, 1388/02/11
Ethics committee reference number
1741-11
Health conditions studied
1
Description of health condition studied
urinary incontinence
ICD-10 code
N00-N99
ICD-10 code description
Diseases of the genitourinary system
Primary outcomes
1
Description
quality of life outcomes
Timepoint
1,2 & 3 months after intervention
Method of measurement
I_QOL questionnaire
Secondary outcomes
1
Description
decrease in episodes of urine loss
Timepoint
1,2 & 3 months after intervention
Method of measurement
voiding diary questionnaire
Intervention groups
1
Description
pelvic floor muscle exercises
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Academic centre of education, culture and research (ACECR), Iran University of medical sciences bran
Full name of responsible person
Dr Mohammad Reza Nateghi
Street address
No. 94, Beginning of South Gandhi St, Vanak Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Academic centre of education, culture and research (ACECR), Iran University of medical sciences bran
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
Academic centre of education, culture and research (ACECR), Iran University of medical sciences bran
Full name of responsible person
Shadab Shahali
Position
Ms in Midwifery
Other areas of specialty/work
Street address
No. 94, Beginning of South Gandhi St, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8879 7403
Fax
Email
shahali@irmed.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Academic centre of education, culture and research (ACECR), Iran University of medical sciences bran
Full name of responsible person
Shadab Shahali
Position
Ms in Midwifery
Other areas of specialty/work
Street address
No. 94, Beginning of South Gandhi St, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8879 7403
Fax
Email
shahali@irmed.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Shadab Shahali
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)