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IRCT20180527039868N1 IRCT 2018-07-04 Sultan Qaboos University Kegel exercise and stress urinary incontinence The effect of home based Kegel exercise on decreasing severity of symptoms and improving quality of life in Omani females identified to have Stress Urinary Incontinence: A prospective randomized controlled study 2639-10-03 anticipated 70 Pending https://irct.ir/trial/31596 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study involves three primary healthcare centers (PHC) in the same area with nearly similar sociodemographic profile of the attendees who avail PHC services. Hence for the purpose of this study and analysis, the three PHCs will be treated as one unit. From among the participants identified having Stress Urinary Incontinence from our ongoing phase I study titled "Prevalence, risk factors, impact on quality of life of Urinary incontinence in urban Omani women", the PI and Co-PI will contact all identified eligible females on telephone; explain the importance of the phase II RCT and invite her to participate in the phase II RCT after explaining the protocol in brief over phone. The subjects willing to be a part of phase II study will be requested to report on a pre-specified day to the same PHC where they were enrolled, explained the protocol of the trial individually by the PI/Co-PI and informed consent taken. The consenting subjects will be assigned identification numbers. A computer based simple random sequence generator will then be used separately at each PHC to direct the subject either to the intervention or control group. The random allocation process will continue till the required sample size target is achieved. Allocation concealment is not possible due to the nature of our study. Adequate care will be taken to prevent contamination. Two days will be allocated to each of the PHC for conduct of the trial. The whole research team consisting of PI, Co-PI and physiotherapist will be available at each center of study on the specified days, Blinding description: The research physiotherapist , is the investigator and outcome assessor also, will be assessing all the subjects at baseline and also 12 weeks post-intervention will be blinded to the groups to which the subject belongs. 3 Stress urinary incontinence. Intervention 1: Intervention group: Patients in the intervention group will report to the Co-PI who is family physician having undergone special training in Kegel Exercise. She will educate the participants individually using audio-visual aids about the anatomy of pelvic floor muscles, continence mechanism and the importance of Kegel’s exercise in management of UI problems and advice the subjects about daily schedule of performing the Kegel’s exercises. The instructions for Kegel exercise involves endurance and speed training. Endurance training (tonic contractions) of pelvic floor muscles consists of slow velocity close to maximum contractions for 3-10 seconds (according to the initial pelvic floor assessment) followed by relaxation for similar duration. For example, if the initial pelvic floor assessment shows a time of sustained contraction of 5 seconds, the woman will be instructed to have slow contractions for 5 seconds for the first week, then increase it to 6 seconds in the next week and so on with the aim of reaching 10 seconds. Thus, the time of sustained contraction will be increased by 1 second per week up to 10 seconds. Speed training (phasic contractions) involves fast moderately strong contractions for 2 seconds followed by relaxation for 2 seconds. The aim is to have 5 sessions of both slow and fast contractions per day. Each session consists of 10 slow and 10 fast contractions. They will be explained to focus on tightening only pelvic floor muscles and not to flex the muscles in abdomen or thighs. The intervention group subjects will be contacted every week on phone to remind and motivate them about the prescribed intervention. Intervention 2: Control group: The participants in control group will be invited for a group lecture (number could vary) on the earliest possible day at the same center of their enrollment. They will be given a 15 minutes lecture using audio-visual aids on the anatomy of pelvic floor muscles, continence mechanism and importance of doing Kegel exercise to alleviate problems related to UI. The control group participants will not be supervised or reminded by weekly telephone communication. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD from the study titled "Phase II study: The effect of home based Kegel exercise on decreasing severity of symptoms and improving quality of life in Omani females identified to have Stress Urinary Incontinence: A prospective randomized controlled study" When: Starting 6 months after publication To whom: Academic institutions only Conditions: For Systematic Reviews and Metaanalysis Where to obtain: Dr. Maisa Al Kiyumi <drmaysa@squ.edu.om> How to obtain: Authorized researchers from academic institutions only can get in touch with Dr Maisa Al Kiyumi at her above email address. Comments:
public Maisa Al-Kiyumi
1909, Al-Mawaleh South, Muscat, Oman.
Muscat Oman 316 +968 24 143407 maysa8172@gmail.com Sultan Qaboos University Hospital scientific Maisa Hamed Sulaiman Al-Kiyumi
1909, Al-Mawaleh South, Muscat, Oman
Muscat Oman 316 +968 24 143407 drmaysa@squ.edu.om Sultan Qaboos University Hospital Oman Oman Oman Non-pregnant females. Able to read and write Attending the primary healthcare centers for any reason 20 years 50 years Female Females in the postnatal period (who delivered in the past 6 months). Women requiring wheel-chair. Women attending for emergency services. Women with prolapse grade III and IV according to the classification of International Continence Society (ICS) N39.3 Stress Urinary Incontinence Treatment - Other Other Intervention group: Patients in the intervention group will report to the Co-PI who is family physician having undergone special training in Kegel Exercise. She will educate the participants individually using audio-visual aids about the anatomy of pelvic floor muscles, continence mechanism and the importance of Kegel’s exercise in management of UI problems and advice the subjects about daily schedule of performing the Kegel’s exercises. The instructions for Kegel exercise involves endurance and speed training. Endurance training (tonic contractions) of pelvic floor muscles consists of slow velocity close to maximum contractions for 3-10 seconds (according to the initial pelvic floor assessment) followed by relaxation for similar duration. For example, if the initial pelvic floor assessment shows a time of sustained contraction of 5 seconds, the woman will be instructed to have slow contractions for 5 seconds for the first week, then increase it to 6 seconds in the next week and so on with the aim of reaching 10 seconds. Thus, the time of sustained contraction will be increased by 1 second per week up to 10 seconds. Speed training (phasic contractions) involves fast moderately strong contractions for 2 seconds followed by relaxation for 2 seconds. The aim is to have 5 sessions of both slow and fast contractions per day. Each session consists of 10 slow and 10 fast contractions. They will be explained to focus on tightening only pelvic floor muscles and not to flex the muscles in abdomen or thighs. The intervention group subjects will be contacted every week on phone to remind and motivate them about the prescribed intervention. Control group: The participants in control group will be invited for a group lecture (number could vary) on the earliest possible day at the same center of their enrollment. They will be given a 15 minutes lecture using audio-visual aids on the anatomy of pelvic floor muscles, continence mechanism and importance of doing Kegel exercise to alleviate problems related to UI. The control group participants will not be supervised or reminded by weekly telephone communication. The frequency of Stress Urinary Incontinence symptoms. Timepoint: At baseline and 12 weeks after intervention. Method of measurement: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The severity of Stress Urinary Incontinence symptoms. Timepoint: At baseline and 12 weeks after intervention. Method of measurement: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The quality of life of women with Stress Urinary Incontinence. Timepoint: At baseline and 12 weeks after intervention. Method of measurement: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). Measure Pelvic Floor Muscle (PFM) strength. Timepoint: At baseline and 12 weeks after intervention. Method of measurement: Vaginal palpation (Oxford Grading System). Measure Pelvic Floor Muscle (PFM) strength and endurance. Timepoint: At baseline and 12 weeks after intervention. Method of measurement: Perineometer. Sultan Qaboos University Approved 2639-06-19 Ethics Committee of Ministry of Health P.O.Box:393, Post code:100, Muscat, Oman Muscat Muscat Oman