Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence (BOFDUI)

Cairo University (CU)

Status: Enrolling

Conditions: Urinary Incontinence

Treatments: Other: Biofeedback training; Other: Biofeedback training and Osteopathy procedure; Other: Osteopathy procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT05957263

F.P.T 2307001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 3 patient groups

Biofeedback training and Osteopathy procedure

Experimental group

Description:

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.

Treatment:

Other: Osteopathy procedure

Other: Biofeedback training and Osteopathy procedure

Other: Biofeedback training

Biofeedback training

Active Comparator group

Description:

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.

Treatment:

Other: Biofeedback training

Osteopathy procedure

Active Comparator group

Description:

The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.

Treatment:

Other: Osteopathy procedure