NCT05355233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

April 15, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

Bebo Concept, diaphragmatic breathing, vaginal delivery

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

bebo concept

EXPERIMENTAL

it is a technique to deal urinary incontinence

Other: bebo concept

diaphragmatic breathing

EXPERIMENTAL

breathing technique to strengthen core muscles

Other: diaphragmatic breathing

Interventions

techniques to remove urinary incontinence

bebo concept

techniques to remove urinary incontinence

diaphragmatic breathing

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous females with a single pregnancy
  • years old
  • Delivery between 37 and 42 weeks of pregnancy
  • to 8 weeks after natural childbirth
  • No contraindications to exercise stated by an obstetrician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinah Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 35248263BACKGROUND
  • 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.

    PMID: 34508116BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Rabiya Noor, PhD

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

May 2, 2022

Study Start

June 15, 2022

Primary Completion

September 15, 2022

Study Completion

October 15, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations