Effects of Kegel ex's With and Without WBV on PFM Strength, Incontinence Intensity, and QOL in Patients With SUI.

Riphah International University

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: whole body vibrator; Other: GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.

Study type: Interventional

Funder types: Other

Identifiers

NCT06242093

S22C14G92026

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diagnosed stress urinary incontinence (SUI)
• Age: 25-50
• Married
• Normal vaginal delivery

Exclusion criteria

• Pelvic inflammatory disease
• Recent operation (C-section)
• Perineal tears
• Chronic constipation
• Pelvic or genital cancer
• Medical problems such as heart disease that limited activities and cardiac pacemaker
• Neuromuscular disorders
• Lack of independent mobility and exercise therapy or WBVT contraindications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

GROUP A WBVT and Conservative treatment

Experimental group

Description:

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

Treatment:

Device: whole body vibrator

GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.

Active Comparator group

Description:

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

Treatment:

Other: GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.