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

NCT ID: NCT06242093

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-04-15

Brief Summary

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.

Detailed 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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GROUP A WBVT 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.
• Time: 3-4 Times/WEEK for 8 weeks

Group Type: EXPERIMENTAL

whole body vibrator

Intervention Type: DEVICE

• 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

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Interventions

whole body vibrator

• 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

Intervention Type: DEVICE

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

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faiza Taufiq, PPDPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Jinnah Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

S22C14G92026

Identifier Type: -

Identifier Source: org_study_id