(1) Objectives: The aim of the present study is investigation the effect of laser acupuncture on some clinical parameters, quality of life and depression of female patients with overactive bladder syndrome. (2) Design: This is a single blinded randomized clinical trial. The patients will not aware about grouping. (3) Setting and conduct: a) filling the informed consent and general information forms. The quality of life and depression questionnaires will fill, too. b) Recording the variables of the present study for 3 days by the patients before starting the study. c) Grouping the patients randomly to control and intervention groups, each included 25 patients. d) Execution the physiotherapy protocol for both groups. e) Filling the quality of life and depression questionnaires at the end of the physiotherapy program. f) Comparing before and after physiotherapy program results. 4) Participants: 30 to 60 years old female patients with overactive bladder syndrome. Most important inclusion criteria: female patients with urinary incontinence; urinary urgency for at least 2 times per 3 days; waking up for urination at least one time at night; urinary frequency at least 8 times per day. Most important exclusion criteria: any other treatment for overactive bladder along with present study; unable to record bladder diary; lower urinary tract infection. (5) Intervention: For intervention group physiotherapy program will be pulsed low level laser radiation with 810 nm wavelength on suggested acupuncture points with energy density of 4 joules/cm2 for 40 seconds/each point. Controlled group will receive sham laser on the same points. Treatment sessions will last 4 weeks, each week included 2 sessions. For consideration of ethics, a complete physiotherapy program included pelvic floor exercise will start for both groups after finishing the study. (6) Variables: Urinary incontinence; frequent urination; urinary urgency; nocturia and also the sf-36 quality of life and beck depression questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022118754N3
Registration date:2015-09-13, 1394/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-13, 1394/06/22
Registrant information
Name
Javad Sarrafzadeh
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
00982122228051-00982122227124
Email address
sarrafzadeh.j@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the laser acupuncture effect on some clinical parameters of female patients with overactive bladder syndrome.
Public title
Investigation the Laser acupuncture effect in treatment of overactive bladder syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female patients with urinary incontinence; urinary urgency for at least 2 times per 3 days; waking up for urination at least one time at night; urinary frequency at least 8 times per day. Exclusion criteria: any other treatment for over activebladder along with present study; unable to ambulate; unable to record bladder diary; lower urinary tract infection; epilepsy; infection at laser acupuncture points; pregnancy; background of radiotherapy and incomplete physiotherapy program of the research.
Age
From 30 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
5th floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Approval date
2014-06-15, 1393/03/25
Ethics committee reference number
105/1275/د/93
Health conditions studied
1
Description of health condition studied
Overactive bladder syndrome
ICD-10 code
32.8
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Urinary incontinence
Timepoint
Before starting the treatment and at the end of each treatment week
Method of measurement
The number of involuntary urine loss during the last 3 days of each treatment week based on bladder diary.
2
Description
Frequent urination
Timepoint
Before starting the treatment and at the end of each treatment week
Method of measurement
Bladder diary for the last 3 days of each treatment week.
3
Description
Nocturia
Timepoint
Before starting the treatment and at the end of each treatment week
Method of measurement
The number of waking up at night for urination based on bladder diary for the last 3 days of each treatment week.
4
Description
Urine urgency
Timepoint
Before starting the treatment and at the end of each treatment week
Method of measurement
The number of urinary urgency based on bladder diary for the last 3 days of each treatment week.
5
Description
Quality of life
Timepoint
Before and after treatment
Method of measurement
SF_36 quastionnaire
6
Description
Depression
Timepoint
Before and after treatment
Method of measurement
Beck depression inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: an 810 nm pulsed low level laser radiation will use on acupuncture points related to overactive bladder syndrome with 4 joules per square centimeter for each point.
Category
Rehabilitation
2
Description
Placebo-controlled group: Sham pulsed low level laser on acupuncture points related to overactivity bladder syndrome.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical therapy clinic of rehabilitation school of Iran university of medical science
Full name of responsible person
Javad Sarrafzadeh
Street address
Physiotherapy Clinic of School of Rehabilitation Sciences, Madadkaran st., Shahnazari st, Mirdamad st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Seyed Ali Javad Moosavi, Vice chancellor for research
Street address
5th Floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Vice chancellor for research
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
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran st., Shahnazari st, Mirdamad St
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences.
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran st., Shahnazari st, Mirdamad St
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 82122220946
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences.
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran st., Shahnazari st, Mirdamad St.
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)