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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06242093
• Other study ID #: S22C14G92026
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

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

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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