Comparative Effects of Bebo Concept and Diaphragmatic Breathing Technique on Stress Incontinence

Comparative Effects of Bebo Concept and Diaphragmatic Breathing Technique on Stress Incontinence in Females After Vaginal Birth

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: bebo concept; Other: diaphragmatic breathing

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Jinah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bebo concept; it is a technique to deal urinary incontinence	Other: bebo concept; techniques to remove urinary incontinence
Experimental: diaphragmatic breathing; breathing technique to strengthen core muscles	Other: diaphragmatic breathing; techniques to remove urinary incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDI-6 (Urinary distress inventory, short form)	Urogenital Distress Inventory-6 (UDI-6) used to diagnose individuals with urinary incontinence	6 months
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Riphah International University

Publications and helpful links

General Publications

• 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.
• Śnieżek A, Czechowska D, Curyło M, Głodzik 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Bebo Concept, diaphragmatic breathing, vaginal delivery
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Respiratory Aspiration; Urinary Incontinence, Stress
• Other Study ID Numbers: REC/RCR&AHS/21/0524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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