Evaluating the efficacy of Hot Cupping Method, on signs and symptoms and quality of life of Female Urinary Incontinence according to International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) and Incontinence Quality of Life (I-QOL) questionnaires compared to Tolterodine
Design
Randomized clinical trial; Randomized simple method has been done. Not blind, parallel group randomized trial. 30-70 old women with urge or mixed urinary incontinence are allocated into control and intervention groups. Each group having 38 subjects.
Settings and conduct
Samples are selected from Farhangian Clinic and Pelvic Floor Disorders Clinic of Imam Khomeini Hospital. They are allocated into two groups whit Simple Randomization Method, treated with Static Hot Dry Cupping and drug therapy with Tolterodine 2 mg.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 30-70 old women with Urge or mixed urinary incontinence; Being symptomatic for at least 3 months; not been treated for at least 2 week before study.
Exclusion criteria: Acute or Recurrent Urinary Tract Infection; pregnancy or lack of contraception; chronic degenerative neuromuscular disease; Bladder cancer or previous record of it; pain of bladder or painful urine voiding; record of pelvic surgery during past one year; Excessive Weight Loss; Uncontrolled diabetes.
Intervention groups
Intervention group is treated with Static Hot Dry Cupping, The area of set cups is navel to pubic area; twice a week, Intervention time is 6 weeks.
Control group: patients will receive one tablet of 2 mg of tolterodine, twice a day, Intervention time is 6 weeks.
Results will be evaluated on weeks 3 and 6 and one month after the end of intervention.
Main outcome variables
evaluating of frequency, time and the amount of urine leakage and quality of life after treatment using ICIQ-SF and I-QOL questionnaires
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190527043729N2
Registration date:2021-11-21, 1400/08/30
Registration timing:prospective
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
leila ghanbaryan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5283 2978
Email address
l-ghanbaryan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Cupping Method on Urinary Incontinence in Women: A Randomized Clinical Trial
Public title
"Effect of Cupping Method in treatment of Urinary incontinence"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30-70 Old Women with Urge or Mixed urinary Iincontinence; Being symptomatic for at least 3 months;
Not been treated for at least 2 week before study
Exclusion criteria:
Acute or Recurrent Urinary Tract Infection
Pregnancy or Lack of Contraception
Chronic Degenerative Neuromuscular Disease
Bladder Cancer or previous record of it
Pain of Bladder or Painful Urine Voiding
Record of Pelvic Surgery during past one year
Excessive Weight Loss
Uncontrolled Diabetes
Age
From 30 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
76 Women with Urge or Mixed Urinary Incontinence referred to Farhagyan Clinic, Behbahan University of Medical Sciences and Pelvic Floor Clinic of Imam Khomeini Hospital belongs to Tehran University of Medical Sciences, During the year 1400 are available to study and each person is randomly assigned to one of two groups. The randomization method is simple and individual randomization unit. The tool used in randomization is Excel software.
Blinding (investigator's opinion)
Not 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 Tehran University of Medical Sciences
Street address
13 Floor, A Block, Headquarters of the Ministry of Health and Medical Education, Simayeiran Street, Between South Flamak and Zar Afshan Street, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.TUMS.VCR.REC.1399.542
Health conditions studied
1
Description of health condition studied
Urge Incontinence
ICD-10 code
N39.41
ICD-10 code description
Urge incontinence
2
Description of health condition studied
Mixed Incontinence
ICD-10 code
N39.46
ICD-10 code description
Mixed incontinence
Primary outcomes
1
Description
Frequency of urinary leakage
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
2
Description
The amount of urine leakage
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
3
Description
Time leakage: leakage befor sleep
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
4
Description
Time of leakage: leakage before reaching the bathroom
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
5
Description
Time leakage: leakage of urine with coughing and sneezing
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
6
Description
The leakage of urine: leakage of urine with exercise
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
7
Description
The leakage of urine: urine leakage after urination immediately prior to wearing underwear
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
8
Description
Assessment of changes in quality of life
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
Incontinence Quality of Life (I-QOL) questionnaire
Secondary outcomes
1
Description
presumptive skin complications
Timepoint
3 weeks after research start and 6 weeks after that (end of intervention)
Method of measurement
Measurement form of drug complications According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Intervention groups
1
Description
Intervention group is treated with Static Hot Dry Cupping, With flaming alcohol cotton, a vacuum is created in each cup so that the cup sticks to the skin. The skin should protrude 2 to 3 cm into the cup. The cups are 45 mm in diameter. 4 to 6 cups, depending on the size of the person, are placed in two rows from below the navel to the pubic area and are kept for twenty minutes, twice a week, for 6 weeks.
Category
Treatment - Devices
2
Description
Control group: patients will receive one tablet of 2 mg of tolterodine, Produced by Tehran Daru Pharmaceutical Company, twice a day, Intervention time is 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhangian Clinic, Behbahan University of Medical Sciences
Full name of responsible person
Leila Ghanbaryan
Street address
Farhangian Clinic, Moallem Square, Moallem Street
City
Behbahan
Province
Khouzestan
Postal code
6361914561
Phone
+98 61 5273 4260
Email
Lghanbaryan@yahoo.com
2
Recruitment center
Name of recruitment center
Pelvic Floor Clinic of Imam Khomeini Hospital belongs to Tehran University of Medical Sciences