Evaluation of the Efficacy and safety of Pulsed Electromagnetic Stimulation on the improvement of urinary symptoms in women with urge incontinence, stress incontinence and mixed (urge/stress) incontinence referred to a private urinary incontinence treatment clinic
Lower urinary tract symptoms or LUTS is common between women especially in 40-60 years old. There are many therapeutic methods for LUTS and incontinence such as behavioral therapy and biofeedback, pharmacological therapy, electrical stimulation and surgery. There is a new method called pulsed electromagnetic stimulation which seems to be less invasive and while improving symptoms has a positive effect on the quality of life of the patients.
This clinical trial will be done on 100 women with urinary incontinence. At least 21 years of age and having reading and writing skills for the participants is required. People with history of known psychological illness will be excluded from the study.
The severity of urinary incontinence will be determined by the 4 questions in the standard questionnaire BFLUTS. After that patients will undergo two sessions a week for 6 weeks. Each session will consists of 2 phases for 20 minutes that each will be 10 minutes and there will be 5 minutes of interruption between these 2 phases.
The device will be used as a chair (NOVAmag NT-60) and the patient will sit on the chair and blow to the patient. After treatment, patients will be asked about possible side. Also, the score of the BFLUTS questionnaire will be calculated again 3 and 6 months after the treatment. The efficacy of the treatment will be to reduce the number of pads used by patient to 1 or 0. Also, the number of pads used will be examined as a separate variable to determine the total amount of pads used by patient before and after treatment and their differences in general.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710034582N7
Registration date:2017-11-13, 1396/08/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-13, 1396/08/22
Registrant information
Name
Ali Hamidi Madani
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 5259
Email address
hamidimadani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy and safety of Pulsed Electromagnetic Stimulation on the improvement of urinary symptoms in women with urge incontinence, stress incontinence and mixed (urge/stress) incontinence referred to a private urinary incontinence treatment clinic
Public title
The effect of pulsed electromagnetic stimulation on the improvement of urinary symptoms in women with urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 21 years of age; ability to read and write; having one of the types of stress; urge or mixed incontinence
Exclusion Criteria: Overflow urinary incontinence; acute and severe pelvic infections; severe heart arrhythmia; known psychological disease history; neurological disorders such as stroke; parkinson; epilepsy and MS; current pregnancy; previous surgery for treatment of incontinence; history of pelvic or gynecologic surgery in last 3 weeks or next coming 8 weeks; pelvic organs prolapsed surgery; trauma of pelvis or perineum; neurogenic bladder; previous magnetic stimulation therapy; simultaneous use of alpha adrenergic agonist drugs (terazosin, tamsulosin, doxazosin), diuretics and or using any drugs that exacerbate incontinence; pelvic organs prolapsed (POP); doubt to the bladder fistula; urinary tract infection or hematuria; residual urine volume>200 milliliters
Age
From 21 years old to 139 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Rasht, Gas Sq., West Shahid Beheshti Blvd., opposite of Sepah Bank
City
Rasht
Postal code
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.GUMS.REC.1396.138
Health conditions studied
1
Description of health condition studied
Urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Treatment of urinary incontinence
Timepoint
3 and 6 months after intervention
Method of measurement
Calculate the relevant questions in the BFLUTS standard questionnaire
2
Description
Reducing the number of used pads
Timepoint
3 and 6 months after intervention
Method of measurement
Calculate the relevant questions in the BFLUTS standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Pulse electromagnetic stimulation using a NOVAmag NT-60 device for 6 weeks, a weekly two sessions and each session for 20 minutes
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ali Hamidi Madani's private clinic
Full name of responsible person
Dr. Ali Hamidi Madani
Street address
Physicians Building, opposite the Shahed school, after the passing bridge, Namaz Garden
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Centre, Guilan University of Medical Sciences
Full name of responsible person
Head of Urology Research Centre, Dr. Siavsh Falahatkar
Street address
Urology Research Centre, Razi Hospital, Sardar Jangal Street
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre, Guilan 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
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadalizadeh
Position
Medical student/ Co worker
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Dr. Ali Hamidi Madani
Position
Urologist / Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
a.hamidimadani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Master Degree/ Researcher of Urology Research Center
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)