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

NCT06242093 | Completed

• 1 other identifier: S22C14G92026
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Pelvic floor; Quality of life; urinary incontinence; pelvic floor disorders

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

GROUP A WBVT and Conservative treatment

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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.

Interventions

whole body vibrator 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 A WBVT and Conservative treatment

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

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

Eligibility Criteria

• Age: 25 Years - 50 Years
• Gender Eligibility Details: stress urinary incontinence after pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Pelvic Floor Disorders

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Faiza Taufiq, PPDPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: March 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)