An interventional study of whole body vibrator and GROUP B Pelvic floor muscle training (PFMT) and conservative treatment. in Stress Urinary Incontinence, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
Urinary incontinence, characterized by involuntary loss of urine (International Continence Society), is a serious social and health issue whose incidence is increasing. Urinary incontinence refers to a condition in which urine is inadvertently excreted from the bladder to the urethra, usually due to a disability or an incapacity to control the bladder and urethral sphincter. Urinary incontinence is a common complaint in women, which can have an important influence on the quality of her life. Its prevalence is between 10% and 40%, and the most common form is stress urinary incontinence. Age, body mass index, genetic factors, pregnancy and delivery, and a history of hysterectomy, smoking, race, constipation and menopause have been considered as its risk factors.
Urinary incontinence, characterized by involuntary loss of urine (International Continence Society), is a serious social and health issue whose incidence is increasing. Urinary incontinence refers to a condition in which urine is inadvertently excreted from the bladder to the urethra, usually due to a disability or an incapacity to control the bladder and urethral sphincter. Urinary incontinence is a common complaint in women, which can have an important influence on the quality of her life. Its prevalence is between 10% and 40%, and the most common form is stress urinary incontinence. Age, body mass index, genetic factors, pregnancy and delivery, and a history of hysterectomy, smoking, race, constipation and menopause have been considered as its risk factors.
A Randomized controlled trial will be conducted to determine the effects of Kegel exercises with and without whole body vibration on pelvic floor muscle strength, incontinence intensity and quality of life in patients with stress urinary incontinence. A sample size of 26 SUI women's will be taken, Data will be collected from the private clinical setups of Lahore by using IQOL, Urinary intensity questionnaire: Urinary Incontinence Questionnaires (King's Health Questionnaire (KHQ), Muscle strength: PERFECT scale and SF-36 Questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing WBVT and Conservative treatment and other group with Pelvic floor muscle training with conservative treatment. The interventions will be provided for 30 minutes for 3-4 D/Week for 4 months. All participants in both groups will be evaluated before and after the treatment programs. Total duration of study will be 8 months after the approval of synopsis. Data will be analyzed by using SPSS 26.
KEY WORDS: Pelvic floor muscle strength, Quality of life, Stress urinary incontinence, Whole body vibration.
670 studies on the registry are indexed under Urinary Incontinence, Stress; 122 are open to participants now.
This study's enrollment of 26 is below the median of 69 across 520 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.
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Exclusion Criteria:
WBVT and Conservative treatment * Group A will receive WBVT with conservative treatment. The treatment will be given with the frequency of 34 times/week for 25-30 minutes with the help of Galileo vibration platform. * Time: 3-4 Times/WEEK for 8 weeks
Device: whole body vibrator
Pelvic floor muscle training (PFMT) and conservative treatment. * Group B will receive (PFMT) with conservative treatment. The PMFT group will be educated to do each exercise in 3-4 set with 15-20 repetitions and a 60-second relax between each set. * Time: 3-4 Times/WEEK for 8 weeks
Other: GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.
• WBVT and Conservative treatment Group A will receive WBVT with conservative treatment. The treatment will be given with the frequency of 34 times/week for 25-30 minutes with the help of Galileo vibration platform
Pelvic floor muscle training (PFMT) and conservative treatment. Group B will receive (PFMT) with conservative treatment. The PMFT group will be educated to do each exercise in 3-4 set with 15-20 repetitions and a 60-second relax between each set. Time: 3-4 Times/WEEK for 8 weeks
The incontinence quality of life (QOL) questionnaire
A disease-specific questionnaire that measures incontinence-related quality of life (QoL).Format: 22 items evaluating concerns related to incontinence, which can be divided into 3 sub-scales: i.e. 1.avoidance and limiting behavior, 2. psycho-social impact, 3.social embarrassment. Scoring: Items are scored on a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all). Scores are then transformed to a scale score ranging from 0-100 points, with higher scores indicating higher QoL
Time frame: 8 weeks
Urinary intensity questionnaire
urinary incontinence questionnaires (King's Health Questionnaire \[KHQ\]:To assess and to evaluate urinary function for patients at different levels of urinary function, related to urinary leakage problems, frequency problems, and related to retention problems. The King's Health Questionnaire (KHQ) was designed to evaluate the impact of urinary incontinence on the quality of life. (r= \>0.60).
Time frame: 8 weeks
SF-36
QoL was assessed by the validated Portuguese version of the self-reported MOS SF-36, which consists of eight subscales: (1) Physical Role Function, (2) Physical Functioning, (3) Bodily Pain, (4) General Health Perception, (5) Vitality, (6) Social Role Functioning, (7) Emotional Role functioning, and (8) Mental Health. A substantial body of research supports the reliability of the SF-36 measurements. Subscale scores range from 0 to 100, with a lower score indicating lower QoL for that subscale. SF-36 (Cronbach's alpha greater than 0.85, reliability coefficient greater than 0.75).
Time frame: 8 weeks
WHOLE BODY VIBRATION PLATFORM
The Galileo is a platform with a sagittal axle on which a teeterboard is tilted up and down (5 mm) at a variable frequency of 5-30 Hz. This movement produces mechanical oscillations with an average cycle length of about 40 msec, which is the time required to induce a natural monosynaptic stretching reflex in the respective muscle via the muscle spindle during one up and down movement.
Time frame: 8 weeks
Plan to share: No
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Ran from Mar 2023 to primary completion in Mar 2024, 12 months.
Of 232 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 12 months is below that.
Counting every sponsor, half of 277 studies reached it within 20 months; a quarter within 10 and three quarters within 43.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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