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

NCT ID: NCT05355233

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2022-10-15

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bebo concept

it is a technique to deal urinary incontinence

Group Type: EXPERIMENTAL

bebo concept

Intervention Type: OTHER

techniques to remove urinary incontinence

diaphragmatic breathing

breathing technique to strengthen core muscles

Group Type: EXPERIMENTAL

diaphragmatic breathing

Intervention Type: OTHER

techniques to remove urinary incontinence

Interventions

bebo concept

techniques to remove urinary incontinence

Intervention Type: OTHER

diaphragmatic breathing

techniques to remove urinary incontinence

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Rabiya Noor, PhD

Role: STUDY_CHAIR

Riphah International University

Locations

Jinah Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 35248263 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34508116 (View on PubMed)

Other Identifiers

REC/RCR&AHS/21/0524

Identifier Type: -

Identifier Source: org_study_id