Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence (BOFDUI)

The Combined Effect of Biofeedback Training and Osteopathic Procedures for the Treatment of Functional Daytime Urinary Incontinence: a Prospective, Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Biofeedback training and Osteopathy procedure; Other: Biofeedback training; Other: Osteopathy procedure

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 Type: Interventional
• Enrollment (Estimated): 117
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hany M Elgohary, PHD; Phone Number: 00201093182291; Email: gohary75pt@hotmail.com
• Study Contact Backup: Name: Yossef M Elbaalawy, PHD; Phone Number: 00201002776512; Email: Youssef.mohamed@pt.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Recruiting
    • Hany Mohamed Elgohary
    • Contact: Hany M Elgohary, PhD; Phone Number: 0590997821; Email: gohary75pt@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Biofeedback 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; Other Names: BTOP; Other: 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.; Other Names: BIOFB; Other: Osteopathy 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.; Other Names: OSP
Active Comparator: 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.	Other: 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.; Other Names: BIOFB
Active Comparator: 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.	Other: Osteopathy 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.; Other Names: OSP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 24-hour pad test	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	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Lower Urinary Tract Symptom Score	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	10 weeks
Assessment of the frequency of daytime urinary incontinence	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.	10 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: 24-hour pad test; Biofeedback training; Osteopathic procedures; functional daytime urinary incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Diurnal Enuresis
• Other Study ID Numbers: F.P.T 2307001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: i have no intent to share my results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No