Urinary Incontinence
Conditions
Keywords
Biofeedback training, Osteopathic procedures, 24-hour pad test, functional daytime urinary incontinence
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.
Interventions
OTHERBiofeedback training and Osteopathy procedure
the biofeedback training lasts 10 weeks and involves 3 sessions per week, with each session lasting for 15 minutes. 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 muscle. muscle inhibition for the psoas muscle, deep massages in the obturator foramen, stretching for the greater omentum, and abdominal maneuvers. a high velocity, low amplitude manipulation performed for the sacroiliac joint and T10-L2 region. The treatments were implemented in phases, with multiple sessions for each phase over a 10-week period. Each osteopathy session typically lasted 30 minutes, with the myofascial, visceral, and articular techniques performed twice a week for 15 minutes each session for 10 weeks, and the high velocity, l
OTHERBiofeedback 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.
OTHEROsteopathy procedure
specific techniques included muscle inhibition for the psoas muscle, deep massages in the obturator foramen, stretching for the greater omentum, and abdominal maneuvers. In addition, there was a high velocity, low amplitude manipulation performed for the sacroiliac joint and T10-L2 region. The treatments were implemented in phases, with multiple sessions for each phase over a 10-week period. Each osteopathy session typically lasted 30 minutes, with the myofascial, visceral, and articular techniques performed twice a week for 15 minutes each session for 10 weeks, and the high velocity, low amplitude manipulation performed three times a week for 15 minutes each session for 10 weeks.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
both participants and assessors will be blind for the treatment procedures
Intervention model description
controlled, double-blinded, and randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
Primary ContactHany M Elgohary, PHD
Backup ContactYossef M Elbaalawy, PHD
Outcome results
None listed