Clinical trial NCT05957263: Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence
Official title: The Combined Effect of Biofeedback Training and Osteopathic Procedures for the Treatment of Functional Daytime Urinary Incontinence: a Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: Biofeedback training
Osteopathic procedures
24-hour pad test
functional daytime urinary incontinence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 117
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled, double-blinded, and randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The 24-hour pad test
timeFrame: 10 weeks
Secondary outcomes:
measure: Pediatric Lower Urinary Tract Symptom Score
timeFrame: 10 weeks
measure: Assessment of the frequency of daytime urinary incontinence
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hany Mohamed Elgohary
Study officials:
References:
citation: Elgohary HM, Al Jaouni SK, Selim SA. Effect of ultrasound-enhanced Nigella sativa seeds oil on wound healing: An animal model. J Taibah Univ Med Sci. 2018 Jun 27;13(5):438-443. doi: 10.1016/j.jtumed.2018.02.008. eCollection 2018 Oct.