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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: whole body vibrator; Other: GROUP B Pelvic floor muscle training (PFMT) and conservative treatment.

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 44000
      • Jinnah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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
Active Comparator: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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).	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.	8 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Faiza Taufiq, PPDPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; pelvic floor disorders; urinary incontinence; Pelvic floor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: S22C14G92026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No