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Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence (BOFDUI)

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biofeedback training and Osteopathy procedure
Biofeedback training
Osteopathy procedure
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Biofeedback training, Osteopathic procedures, 24-hour pad test, functional daytime urinary incontinence

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hany Mohamed ElgoharyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Biofeedback training and Osteopathy procedure

Biofeedback training

Osteopathy procedure

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
July 7, 2023
Last Updated
July 14, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05957263
Brief Title
Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence
Acronym
BOFDUI
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Biofeedback training, Osteopathic procedures, 24-hour pad test, functional daytime urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
controlled, double-blinded, and randomized clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
both participants and assessors will be blind for the treatment procedures
Allocation
Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback training and Osteopathy procedure
Arm Type
Experimental
Arm 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.
Arm Title
Biofeedback training
Arm Type
Active Comparator
Arm 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.
Arm Title
Osteopathy procedure
Arm Type
Active Comparator
Arm Description
The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility.
Intervention Type
Other
Intervention Name(s)
Biofeedback training and Osteopathy procedure
Other Intervention Name(s)
BTOP
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Biofeedback training
Other Intervention Name(s)
BIOFB
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Osteopathy procedure
Other Intervention Name(s)
OSP
Intervention Description
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.
Primary Outcome Measure Information:
Title
The 24-hour pad test
Description
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
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Pediatric Lower Urinary Tract Symptom Score
Description
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
Time Frame
10 weeks
Title
Assessment of the frequency of daytime urinary incontinence
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany M Elgohary, PHD
Phone
00201093182291
Email
gohary75pt@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yossef M Elbaalawy, PHD
Phone
00201002776512
Email
Youssef.mohamed@pt.cu.edu.eg
Facility Information:
Facility Name
Hany Mohamed Elgohary
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M Elgohary, PhD
Phone
0590997821
Email
gohary75pt@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
i have no intent to share my results
Citations:
PubMed Identifier
31435359
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.
Results Reference
result

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Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence

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