Comparing the Combined Effect of Stability Exercises and Interference Current in Improving Maximal Intravaginal Pressure, Frequency of Urinary Incontinence, and Quality of Life in Women with Stress Urinary Incontinence
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General information
22
30
2230
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To improve the precision of the results and enhance the study power, the sample size was increased to 15 participants per group.
To improve the precision of the results and enhance the study power, the sample size was increased to 15 participants per group.
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با هدف افزایش دقت نتایج و بهبود توان مطالعه، حجم نمونه به ۱۵ نفر در هر گروه افزایش یافت
با هدف افزایش دقت نتایج و بهبود توان مطالعه، حجم نمونه به ۱۵ نفر در هر گروه افزایش یافت
Recruitment centers
#1
Name of recruitment center - English: Bahar physiotherapy clinic
Name of recruitment center - Persian: کلینیک فیزیوتراپی بهار
Full name of responsible person - English: Reyhane Sekandari
Full name of responsible person - Persian: ریحانه سکندری
Street address - English: Reza Doctors Building, Ground Floor, Bahar Physiotherapy, Vakil Abad 2, Vakil Abad Blvd
Street address - Persian: بلوار وکیل اباد، نبش وکیل اباد ۲۱، ساختمان پزشکان رضا، طبقه همکف، فیزیوتراپی بهار
City - English: مشهد
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 91
Phone: +98 51 3603 9562
Fax:
Email: r.sekandari1@gmail.com
Web page address:
Name of recruitment center - English: Ghaem physiotherapy clinic
Name of recruitment center - Persian: کلینیک فیزیوتراپی قائم
Full name of responsible person - English: Reyhane Sekandari
Full name of responsible person - Persian: ریحانه سکندری
Street address - English: Narjes building, first floor, Physiotherapy Department, Qaem Hospital, Nurse Street, Mashhad, Iran
Street address - Persian: خیابان پرستار، بیمارستان قائم، دپارتمان فیزیوتراپی، ساختمان نرجس، طبقه اول.
City - English: مشهد
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176699199
Phone: +98 51 3841 1538
Fax:
Email: zarandiMJ1@mums.ac.ir
Web page address:
Name of recruitment center - English: BaharGhaem physiotherapy clinic Name of recruitment center - Persian: کلینیک فیزیوتراپی بهارقائم Full name of responsible person - English: Reyhane Sekandari Full name of responsible person - Persian: ریحانه سکندری Street address - English: Reza Doctors BuildingNarjes building, Ground Floorfirst floor, Bahar Physiotherapy Department, Vakil Abad 2Qaem Hospital, Vakil Abad BlvdNurse Street, Mashhad, Iran Street address - Persian: بلوار وکیل ابادخیابان پرستار، نبش وکیل اباد ۲۱بیمارستان قائم، دپارتمان فیزیوتراپی، ساختمان پزشکان رضانرجس، طبقه همکف، فیزیوتراپی بهاراول. City - English: مشهد City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 919176699199 Phone: +98 51 3603 95623841 1538 Fax: Email: r.sekandari1zarandiMJ1@gmail.commums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Majid Ghayour Mobarhan
Full name of responsible person - Persian: دکتر مجید غیور مبرهن
Street address - English: Ghoreshi Building, Doctora Crossroad
Street address - Persian: چهارراه دکترا جنب سینما هویزه، ساختمان قریشی
City - English: Masshad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9919191778
Phone: +98 51 3841 1538
Fax:
Email: vcresearch@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Majid Ghayour Mobarhan
Full name of responsible person - Persian: دکتر مجید غیور مبرهن
Street address - English: Ghoreshi Building, Doctora Crossroad, Mashhad, Iran
Street address - Persian: ایران، مشهد، چهارراه دکترا جنب سینما هویزه، ساختمان قریشی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9919191778
Phone: +98 51 3841 1538
Fax:
Email: vcresearch@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Majid Ghayour Mobarhan Full name of responsible person - Persian: دکتر مجید غیور مبرهن Street address - English: Ghoreshi Building, Doctora Crossroad, Mashhad, Iran Street address - Persian: ایران، مشهد، چهارراه دکترا جنب سینما هویزه، ساختمان قریشی City - English: MasshadMashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9919191778 Phone: +98 51 3841 1538 Fax: Email: vcresearch@mums.ac.ir Web page address:
Protocol summary
Study aim
To compare the effects of stability exercises (with emphasis of pelvic floor muscles) combined with interferential currents versus the same stability exercises alone on improving intravaginal pressure, incontinence rate, quality of life (UI_SF ICIQ questionnaire) in the management of women with stress urinary incontinence.
Design
A single-blind randomized controlled trial with parallel-groupwith controlled group will be performed on 22 women with stress urinary incontinence. The www.sealedenvelope.com website will be used for randomization.
Settings and conduct
Patients will be visited in the Ghaem physiotherapy clinic, Mashhad, Iran. The patients will be reviewed by the principal investigator in terms of inclusion and exclusion criteria. The patients will be examined by the assessor who is blinded to the patient's label. Finally, the treatment will be started by the physiotherapist. The physiotherapist was blinded to patients allocation. In the control group, the patients will receive stability exercises and interference currents, no output will be used.
Participants/Inclusion and exclusion criteria
Patients with mild and severe stress urinary incontinence without any other significant urogenital disorders.
Intervention groups
Both groups are examined one week after the inclusion and exclusion criteria and then, the intervention group receives a combination of stabilization exercises 3 times a week for 4 weeks with emphasis on the pelvic floor muscles and interference current. The control group is given stabilization exercises 3 times a week for 4 weeks with emphasis on the pelvic floor muscles along with the placebo interference current. Both groups receive educational pamphlets
Main outcome variables
Maximum intravaginal pressure and duration of maintenance, number of incontinences, quality of life and score of ICIQ _UI SF questionnaire
General information
Reason for update
To improve the precision of the results and enhance the study power, the sample size was increased to 15 participants per group.
Acronym
IRCT registration information
IRCT registration number:IRCT20161221031506N9
Registration date:2022-07-10, 1401/04/19
Registration timing:prospective
Last update:2025-08-29, 1404/06/07
Update count:1
Registration date
2022-07-10, 1401/04/19
Registrant information
Name
Salman Nazary-Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6713
Email address
nazaryms@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-07-19, 1402/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Combined Effect of Stability Exercises and Interference Current in Improving Maximal Intravaginal Pressure, Frequency of Urinary Incontinence, and Quality of Life in Women with Stress Urinary Incontinence
Public title
Comparing the Combined Effect of Stability Exercises with Emphasis on Pelvic Floor Muscles and Interference Current on Improving the symptoms of Women with Stress Urinary Incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have experienced stress urinary incontinence at least twice a week for two weeks. Stress urinary incontinence was confirmed by urodynamic tests and clinical examination.
Mild and moderate stress urinary incontinence
No history of taking anticholinergic drugs and other drugs during physiotherapy period.
Exclusion criteria:
smoking
Known types of neuropathy
Virginity
Pregnancy and lactation
History of pelvic surgery in the past year
History of reconstructive surgery in the genitourinary system
Having a urinary tract infection
Chronic asthma and cough (more than three months)
Having perceptual problems and mental illness based on a doctor's examination
History of genitourinary neoplasia
History of abnormalities in the genitourinary system
Having any type of urinary incontinence other than pure stress urinary incontinence
Severe stress urinary incontinence
Severe prolapse
Urethral hyper mobility
Intrinsic sphincter dysfunction
Severe neuromuscular disorders that compromise exercise performance
Age
To 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The random numbers is prepared using the website www.sealedenvelope.com in terms of 1 and 2. The 22 cards (taking into account 20% dropout) is placed into sealed envelopes. After the evaluation, the patients selected the card according to the order placed in the envelope. If the number of 1 is observed, the patient will be included in the intervention group, and if the number of 2 is observed, the patients will be included in the control group.Another physiotherapist who is not aware about the allocation process will evaluate the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and the statistical analyzer will be blinded to the group allocation. The patient will receive a placebo interferential current. The outcome assessor will evaluate the patients in a separate room. She has not any information regarding the patient group. In addition, statistical analysis will be blinded to group allocation. In the spss file, codes a, and b will be defined for intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Science's Research and Development Deputy Office, Across 18th University Street, University Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-06-28, 1401/04/07
Ethics committee reference number
IR.MUMS.FHMPM.REC.1401.062
Health conditions studied
1
Description of health condition studied
Stress urinary inconvenience
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Mean maximum intravaginal pressure
Timepoint
Immediately after allocation into , 4 and 8 weeks after starting treatment
Method of measurement
Pressure biofeedback
2
Description
Quality of life
Timepoint
Immediately after allocation into , 4 and 8 weeks after starting treatment
Method of measurement
توسط پرسشنامه I_QOL
3
Description
ICIQ_UI SF questionnaire score
Timepoint
Immediately after allocation into , 4 and 8 weeks after starting treatment
Method of measurement
ICIQ_UI SF questionnaire
4
Description
Duration of maintenance of maximum intravaginal pressure
Timepoint
Immediately after allocation into , 4 and 8 weeks after starting treatment
Method of measurement
Pressure biofeedback
5
Description
Frequent urinary incontinence for a week
Timepoint
Immediately after allocation into , 4 and 8 weeks after starting treatment
Method of measurement
With bladder diary
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will receive 12 sessions of interferential currents 4 weeks, 3 times per week. The intensity of the interferential currents causes the torelated contractions. Electrodes placement will be done bipolarly and by the Dumoulin method. Then, the patients will be performed the stability exercises. The patients in this group should perform the stability exercises for 4 weeks, 5 times per week. It should be noted that three out of five times will be performed under the physiotherapist' supervision. Generally, the duration of the exercises is 30 minutes per session. The patients should repeat each exercise 10-20 times in the requested positions. In the first session, people will be given exercise booklets, which contain pictures of the prescribed exercises. The patienrts should record their performed exercises during the week. The participants in the intervention group are trained to perform stability exercises while exhaling. Individuals are also asked to do diaphragmatic breathing for 3-4 minutes before starting stability exercises. This improves the blood circulation of the intestines and improves the function and rhythm of the pelvic floormuscle. Also, patients should have diaphragmatic breathing during rest periods betwwen exercises.
Category
Rehabilitation
2
Description
Control group:Similarly, the intervention group performs stabilization exercises 5 times a week for 4 weeks, 3 of which are performed under the supervision of a physiotherapist after receiving the placebo interference current, and the other 2 times are performed at home. Everyone is given an educational pamphlet