Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence

Not Applicable

Recruiting

• Conditions: Urinary Incontinence
• Interventions: Other: Biofeedback training; Other: Osteopathy procedure; Other: Biofeedback training and Osteopathy procedure

• Registration Number: NCT05957263
• Lead Sponsor: Cairo University

Brief Summary

The study will enroll 113 participants, randomly will be assigned to one of three groups will receive either group A will receive combined therapy of biofeedback training and osteopathy techniques, group B will receive biofeedback training, group C will receive osteopathy technique only over a period of 10 weeks, followed by an 8-week follow-up period. Outcome measures will include the 24-hour pad test, Pediatric Lower Urinary Tract Symptom Score (PLUTSS), and the bladder diary.

Detailed Description

Children (male and female) with functional daytime urinary incontinence, typically the urge type, who were referred for physical therapy by a urologist were recruited from Mansoura Urology and Nephrology Hospital at Mansoura University. To participate in the study, participants had to be between 6 and 16 years old and have had functional daytime urinary incontinence for at least six months, with at least three episodes per week and a total of at least 60 ml of urine loss per week. Certain exclusion criteria were applied, including not having other types of urinary incontinence, neurological disorders, previous operations on the urinary or bowel system, current use of certain medications that could interfere with study results or pose a risk to the participant's health, severe cognitive impairment or dementia, recent participation in another clinical trial, active urinary tract infection (UTI), not having vascular disorders in the urinary system, and parental refusal to sign the written consent form.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study Start: 2023-07-20
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• between 6 and 16 years old
• have functional daytime urinary incontinence for at least six months
• at least three episodes per week

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Exclusion Criteria

• neurological disorders,
• previous operations on the urinary or bowel system
• current use of certain medications that could interfere with study results
• pose a risk to the participant's health
• severe cognitive impairment or dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback training	Biofeedback training	he biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. During biofeedback-assisted pelvic floor muscle exercises, the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscles.
Osteopathy procedure	Osteopathy procedure	The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.
Biofeedback training and Osteopathy procedure	Biofeedback training and Osteopathy procedure	the biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. During biofeedback-assisted pelvic floor muscle exercises, the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscles. The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.
Biofeedback training and Osteopathy procedure	Biofeedback training	the biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. During biofeedback-assisted pelvic floor muscle exercises, the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscles. The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.
Biofeedback training and Osteopathy procedure	Osteopathy procedure	the biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. During biofeedback-assisted pelvic floor muscle exercises, the child was asked to contract the pelvic floor muscles as if stopping peeing, after which the biofeedback device helps them understand how to better control their muscles. The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.

Primary Outcome Measures

Name	Time	Method
The 24-hour pad test	10 weeks	The pad is weighed at the beginning and end of the test to determine the amount of urine leakage, which is used to estimate the severity of the condition and evaluate the effectiveness of the treatment. Several studies have been used to assess the test-retest reliability of the 24-hour pad test and found it to be a reliable tool for the diagnosis and monitoring of urinary incontinence

Secondary Outcome Measures

Name	Time	Method
Pediatric Lower Urinary Tract Symptom Score	10 weeks	The PLUTSS is a questionnaire used to evaluate lower urinary tract symptoms (LUTS) in children by assessing the frequency and severity of urinary symptoms including urgency, frequency, incontinence, and urinary tract infections. Both children and their parents provide responses, and the scoring ranges from 0-34, with higher scores indicating more severe symptoms. A score of 0-5 is normal, 6-10 is mild, 11-20 is moderate, and 21-34 indicates severe symptoms
Assessment of the frequency of daytime urinary incontinence	10 weeks	Monitoring the frequency of daytime urinary incontinence typically involves maintaining a bladder diary, which is a log of the patient's urination patterns indicating the number of times urination occurs, the amount of urine voided, and the presence of urinary incontinence episodes throughout the day.

Trial Locations

Locations (1)

Hany Mohamed Elgohary; 🇪🇬 Cairo, Egypt