Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Patients with mild and severe stress urinary incontinence without any other significant urogenital disorders.
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Intervention groups
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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
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Main outcome variables
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Maximum intravaginal pressure and duration of maintenance, number of incontinences, quality of life and score of ICIQ _UI SF questionnaire
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-07-10, 1401/04/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-06, 1401/05/15
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Expected recruitment end date
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2023-07-19, 1402/04/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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To 65 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-06-28, 1401/04/07
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Ethics committee reference number
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IR.MUMS.FHMPM.REC.1401.062
Health conditions studied
1
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Description of health condition studied
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Stress urinary inconvenience
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ICD-10 code
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N39.3
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ICD-10 code description
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Stress incontinence (female) (male)
Primary outcomes
1
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Description
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Mean maximum intravaginal pressure
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Timepoint
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Immediately after allocation into , 4 and 8 weeks after starting treatment
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Method of measurement
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Pressure biofeedback
2
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Description
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Quality of life
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Timepoint
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Immediately after allocation into , 4 and 8 weeks after starting treatment
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Method of measurement
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توسط پرسشنامه I_QOL
3
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Description
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ICIQ_UI SF questionnaire score
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Timepoint
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Immediately after allocation into , 4 and 8 weeks after starting treatment
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Method of measurement
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ICIQ_UI SF questionnaire
4
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Description
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Duration of maintenance of maximum intravaginal pressure
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Timepoint
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Immediately after allocation into , 4 and 8 weeks after starting treatment
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Method of measurement
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Pressure biofeedback
5
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Description
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Frequent urinary incontinence for a week
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Timepoint
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Immediately after allocation into , 4 and 8 weeks after starting treatment
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Method of measurement
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With bladder diary
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Personal Grant (Dr Salman Nazary-Moghadam)
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data will be reported in the form of a research article. Raw data will be delivered to researchers for meta analys
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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برای پژوهشگران
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Under which criteria data/document could be used
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For meta-analysis Only.
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From where data/document is obtainable
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Nazary_salman@yahoo.com
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What processes are involved for a request to access data/document
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The response will be sent 3 within months after considering the researcher's request.
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Comments
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