Urinary IncontinenceBOFDUINCT05957263
Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence
A study testing Biofeedback training and Osteopathy procedure, Biofeedback training and Osteopathy procedure in people with Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Biofeedback training and Osteopathy procedure, Biofeedback training and Osteopathy procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- between 6 and 16 years old
- have functional daytime urinary incontinence for at least six months
- at least three episodes per week
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hany Mohamed Elgohary
Cairo, 11432
Hany M Elgohary, PhD, 0590997821, gohary75pt@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Biofeedback training and Osteopathy procedure, Biofeedback training, Osteopathy procedure
- Keywords
- Biofeedback training, Osteopathic procedures, 24-hour pad test, functional daytime urinary incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback training and Osteopathy procedureOther
Also called BTOP
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
Biofeedback trainingOther
Also called BIOFB
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.
Osteopathy procedureOther
Also called OSP
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback training and Osteopathy procedure | Experimental | 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. Receives: Other: Biofeedback training and Osteopathy procedure; Other: Biofeedback training; Other: Osteopathy procedure |
| Biofeedback training | Active comparator | 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. Receives: Other: Biofeedback training |
| Osteopathy procedure | Active comparator | The osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility. Receives: Other: Osteopathy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start20 Jul 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled, double-blinded, and randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mohamed Ibrahim Elgohary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957263
- Sponsor's protocol ID
- F.P.T 2307001
- Acronym
- BOFDUI
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: i have no intent to share my results
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.
PubMed 31435359Ibrahim Elgohary HM, Elfahl AM, Elkholy MN. The combined effect of biofeedback training and osteopathic procedures for the treatment of functional daytime urinary incontinence: A prospective, randomized clinical trial. J Bodyw Mov Ther. 2025 Jun;42:289-296. doi: 10.1016/j.jbmt.2024.12.033. Epub 2024 Dec 24.
PubMed 40325682
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Biofeedback Training and Osteopathic Procedures for the Treatment of Functional Daytime Urinary Incontinence: a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05957263
- Acronym / sponsor ID
- BOFDUI / F.P.T 2307001
- Conditions
- Urinary Incontinence
- Keywords
- Biofeedback training, Osteopathic procedures, 24-hour pad test, functional daytime urinary incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- controlled, double-blinded, and randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Biofeedback training and Osteopathy procedure | Experimental | Other: Biofeedback training and Osteopathy procedure, Other: Biofeedback training, Other: Osteopathy procedurethe 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. |
| Biofeedback training | Active comparator | Other: Biofeedback traininghe 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. |
| Osteopathy procedure | Active comparator | Other: Osteopathy procedureThe osteopathy techniques involved a combination of myofascial, visceral, and articular techniques aimed at restoring and rebalancing internal tensions and improving visceral mobility. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- between 6 and 16 years old
- have functional daytime urinary incontinence for at least six months
- at least three episodes per week
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback training and Osteopathy procedureAlso: BTOPthe 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 | Biofeedback training and Osteopathy procedure |
| Biofeedback trainingAlso: BIOFBthe 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, Biofeedback training and Osteopathy procedure |
| Osteopathy procedureAlso: OSPspecific 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 | Biofeedback training and Osteopathy procedure, Osteopathy procedure |
Primary outcome
The 24-hour pad test
Time frame: 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
2 secondary outcomes
Pediatric Lower Urinary Tract Symptom Score
Time frame: 10 weeks
Assessment of the frequency of daytime urinary incontinence
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Results publication: PubMed 31435359Elgohary 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.
- Derived from this study: PubMed 40325682Ibrahim Elgohary HM, Elfahl AM, Elkholy MN. The combined effect of biofeedback training and osteopathic procedures for the treatment of functional daytime urinary incontinence: A prospective, randomized clinical trial. J Bodyw Mov Ther. 2025 Jun;42:289-296. doi: 10.1016/j.jbmt.2024.12.033. Epub 2024 Dec 24.
- Individual participant dataSharing planned: No. i have no intent to share my results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback training and Osteopathy procedure, Biofeedback training and Osteopathy procedure in people with Urinary Incontinence, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany M Elgohary, PHD (00201093182291, gohary75pt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 24-hour pad test (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.