Comparative Effects of Bebo Concept and Diaphragmatic Breathing Technique on Stress Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
bebo concept
diaphragmatic breathing
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Bebo Concept, diaphragmatic breathing, vaginal delivery
Eligibility Criteria
Inclusion Criteria:
• Primiparous females with a single pregnancy
- 20-40 years old
- Delivery between 37 and 42 weeks of pregnancy
- 6 to 8 weeks after natural childbirth
- No contraindications to exercise stated by an obstetrician
Exclusion Criteria:
Multiple pregnancy
- Caesarean delivery
- Postpartum complications in the form of: separation of the pubic symphysis and sacroiliac joints thrombophlebitis, 3rd and 4th degree of perineal rupture, urinary tract or vaginal infections/infections during the experiment, 3rd and 4th degree of pelvic organ prolapse, 3rd degree of stress urinary incontinence or overactive bladder diagnosed before pregnancy, gynecological surgeries, spine operations, pelvic and spine fractures, injuries, operations on the lower limbs 12 months or less previous to the study, diseases of the nervous system, e.g. MS, stroke, respiratory diseases, diabetes, cancer, rheumatic diseases.
- Refusal to participate in the study
Sites / Locations
- Jinah Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
bebo concept
diaphragmatic breathing
Arm Description
it is a technique to deal urinary incontinence
breathing technique to strengthen core muscles
Outcomes
Primary Outcome Measures
UDI-6 (Urinary distress inventory, short form)
Urogenital Distress Inventory-6 (UDI-6) used to diagnose individuals with urinary incontinence
ICIQ-SF Questionnaire The ICIQ-UI Short Form
The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. This short and simple questionnaire is also of use to general practitioners and clinicians in both primary and secondary care institutions to screen for incontinence, to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence and to facilitate patient-clinician discussions.
Palpation perfect test
It is performed by inserting a finger (or fingers) into the vaginal cavity. Pelvic floor muscle contraction can be felt and the therapist is looking for both a squeeze and lift.
Secondary Outcome Measures
Full Information
NCT ID
NCT05355233
First Posted
April 15, 2022
Last Updated
December 7, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05355233
Brief Title
Comparative Effects of Bebo Concept and Diaphragmatic Breathing Technique on Stress Incontinence
Official Title
Comparative Effects of Bebo Concept and Diaphragmatic Breathing Technique on Stress Incontinence in Females After Vaginal Birth
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pelvic floor muscle dysfunctions can lead to urinary incontinence, a condition which often affects female both during pregnancy and after childbirth. As a result of this, certain exercises are recommended during and after pregnancy to prevent and treat this incontinence, and the BeBo Concept is one of these methods used to prevent pelvic floor muscle dysfunction. Urinary incontinence among female is considered a social disease, which may affect up to 20-60% of the population of female over 18 years of age. The strength and endurance of the pelvic floor muscles decrease significantly after the first delivery. Research shows that 65% of female with urinary incontinence remember that the first episode of urine loss occurred during pregnancy or in the puerperium. Prior to the study, all participants will be informed of the purpose and method of Conducting the research. . A 6-week physical therapy program according to the BeBo Pelvic Floor Training Concept. Individual meetings will be twice a week, each lasting 60 min. Each meeting will consist of a theoretical part lasting up to 10 min and a practical part lasting about 50 min. In addition, each participant will receive a set of exercises to be performed at home once daily. For the experimental group, In the first week (meetings 1 and 2), the homework will include the following activities: concentration on the pelvic floor muscles and becoming aware of them in various body positions, mobilization of the pelvis in a sitting position on a chair- 10x, lying on the back with bent legs and activation of PFM with exhalation, inhalation- relaxation-10x, balance exercise, standing on one leg, 10 s each leg, and so on to 6 weeks. Treatment protocol for Control Group (Diaphragmatic Breathing), Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks. Female will be asked to complete forms before starting the program and again at the end of the 6-week program.
Detailed Description
Pelvic floor muscle dysfunctions can lead to urinary incontinence, a condition which often affects female both during pregnancy and after childbirth. As a result of this, certain exercises are recommended during and after pregnancy to prevent and treat this incontinence, and the BeBo Concept is one of these methods used to prevent pelvic floor muscle dysfunction. Urinary incontinence among female is considered a social disease, which may affect up to 20-60% of the population of female over 18 years of age. The strength and endurance of the pelvic floor muscles decrease significantly after the first delivery. Research shows that 65% of female with urinary incontinence remember that the first episode of urine loss occurred during pregnancy or in the puerperium. Prior to the study, all participants will be informed of the purpose and method of Conducting the research. Each of them will sign an informed consent release to participate in the project and to process personal data for scientific purposes. We confirm that all research will be performed in accordance with relevant guidelines and regulations. A 6-week physical therapy program according to the BeBo Pelvic Floor Training Concept. Individual meetings will be twice a week, each lasting 60 min. Each meeting will consist of a theoretical part lasting up to 10 min and a practical part lasting about 50 min. In addition, each participant will receive a set of exercises to be performed at home once daily. For the experimental group, In the first week (meetings 1 and 2), the homework will include the following activities: concentration on the pelvic floor muscles and becoming aware of them in various body positions, mobilization of the pelvis in a sitting position on a chair- 10x, lying on the back with bent legs and activation of PFM with exhalation, inhalation- relaxation-10x, balance exercise, standing on one leg, 10 s each leg, and so on to 6 weeks. Treatment protocol for Control Group (Diaphragmatic Breathing), Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks. Female will be asked to complete forms before starting the program and again at the end of the 6-week program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Bebo Concept, diaphragmatic breathing, vaginal delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bebo concept
Arm Type
Experimental
Arm Description
it is a technique to deal urinary incontinence
Arm Title
diaphragmatic breathing
Arm Type
Experimental
Arm Description
breathing technique to strengthen core muscles
Intervention Type
Other
Intervention Name(s)
bebo concept
Intervention Description
techniques to remove urinary incontinence
Intervention Type
Other
Intervention Name(s)
diaphragmatic breathing
Intervention Description
techniques to remove urinary incontinence
Primary Outcome Measure Information:
Title
UDI-6 (Urinary distress inventory, short form)
Description
Urogenital Distress Inventory-6 (UDI-6) used to diagnose individuals with urinary incontinence
Time Frame
6 months
Title
ICIQ-SF Questionnaire The ICIQ-UI Short Form
Description
The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. This short and simple questionnaire is also of use to general practitioners and clinicians in both primary and secondary care institutions to screen for incontinence, to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence and to facilitate patient-clinician discussions.
Time Frame
6 months
Title
Palpation perfect test
Description
It is performed by inserting a finger (or fingers) into the vaginal cavity. Pelvic floor muscle contraction can be felt and the therapist is looking for both a squeeze and lift.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Primiparous females with a single pregnancy
20-40 years old
Delivery between 37 and 42 weeks of pregnancy
6 to 8 weeks after natural childbirth
No contraindications to exercise stated by an obstetrician
Exclusion Criteria:
Multiple pregnancy
Caesarean delivery
Postpartum complications in the form of: separation of the pubic symphysis and sacroiliac joints thrombophlebitis, 3rd and 4th degree of perineal rupture, urinary tract or vaginal infections/infections during the experiment, 3rd and 4th degree of pelvic organ prolapse, 3rd degree of stress urinary incontinence or overactive bladder diagnosed before pregnancy, gynecological surgeries, spine operations, pelvic and spine fractures, injuries, operations on the lower limbs 12 months or less previous to the study, diseases of the nervous system, e.g. MS, stroke, respiratory diseases, diabetes, cancer, rheumatic diseases.
Refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rabiya Noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Jinah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35248263
Citation
Toprak N, Sen S, Varhan B. The role of diaphragmatic breathing exercise on urinary incontinence treatment: A pilot study. J Bodyw Mov Ther. 2022 Jan;29:146-153. doi: 10.1016/j.jbmt.2021.10.002. Epub 2021 Oct 20.
Results Reference
background
PubMed Identifier
34508116
Citation
Sniezek A, Czechowska D, Curylo M, Glodzik J, Szymanowski P, Rojek A, Marchewka A. Physiotherapy according to the BeBo Concept as prophylaxis and treatment of urinary incontinence in women after natural childbirth. Sci Rep. 2021 Sep 10;11(1):18096. doi: 10.1038/s41598-021-96550-x.
Results Reference
background
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Comparative Effects of Bebo Concept and Diaphragmatic Breathing Technique on Stress Incontinence
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