Diaphragmatic Breathing Exercises on Urinary Incontinence

NCT04991675 | Completed

• 1 other identifier: 126
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this pilot study was to examine the effect of diaphragmatic breathing exercise on urinary incontinence treatment. The secondary purpose was to compare the effect of pelvic floor muscle exercises and diaphragmatic breathing exercises on urinary incontinence women. Design: Participants were randomized into two groups: pelvic floor muscle exercises (Group PFM n=20) and diaphragmatic breathing exercises (Group DB n=20). Exercise programs consisted of 1 set of contractions per day and each set included 30 repetitions for 6 weeks. Women were asked to complete forms of Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6), Incontinence Quality of Life (I-QOL), and Overactive Bladder (OAB-V3) before starting the program and again at the end of the 6-week program. Changes from baseline were compared in both groups and between the two groups.

Conditions

Urinary Incontinence

Keywords

Diaphragmatic breathing exercise; Pelvic floor muscles exercises; Kegel exercise; Urinary incontinence; Physiotherapy

Outcome Measures

Primary Outcomes (4)

• Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed diaphragmatic breathing exercises at 6 weeks

  The Incontinence Impact Questionnaire (IIQ-7) is used to analyze the impact of UI on various activities and emotional states. Responses were on a 4-step ordered category scale from "not at all" to "greatly". Women were asked to complete those forms before starting the diaphragmatic breathing exercises and again at the end of the 6-week program.

  6 weeks

• Change from baseline the Urogenital Distress Inventory (UDI-6) scores of women who performed diaphragmatic breathing exercises at 6 weeks

  The Urogenital Distress Inventory (UDI-6) is used to analyze the impact of UI on various activities and emotional states. Responses were on a 4-step ordered category scale from "not at all" to "greatly". Questions 1 and 2 of UDI-6 are directed to irritative symptoms, questions 3 and 4 address stress symptoms, others address obstructive or voiding symptoms. Women were asked to complete those forms before starting the diaphragmatic breathing exercises and again at the end of the 6-week program.

  6 weeks

• Change from baseline The Incontinence Quality of Life (I-QOL) scores of women who performed diaphragmatic breathing exercises at 6 weeks

  The Incontinence Quality of Life (I-QOL) contains 22 items, on a 6 point Likert scale ranging from 0 (none) to 5 (very great deal), about limiting behaviors and social life impacts, low scores indicate poorer QoL. Women were asked to complete those forms before starting the diaphragmatic breathing exercises and again at the end of the 6-week program.

  6 weeks

• Change from baseline Overactive Bladder (OAB-V3) scores of women who performed diaphragmatic breathing exercises at 6 weeks

  Overactive Bladder (OAB-V3) questionnaire consists of 8 questions about how bothered one is by symptoms of urinary urgency, urinary frequency, nocturia, ranging from never (0) to always (5). Women were asked to complete those forms before starting the diaphragmatic breathing exercises and again at the end of the 6-week program.

  6 weeks

Secondary Outcomes (4)

• Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed pelvic floor exercises at 6 weeks.

  6 weeks

• Change from baseline Urogenital Distress Inventory (UDI-6) scores of women who performed pelvic floor exercises at 6 weeks.

  6 weeks

• Change from baseline Incontinence Quality of Life (I-QOL) scores of women who performed pelvic floor exercises at 6 weeks.

  6 weeks

• Change from baseline Overactive Bladder (OAB-V3) scores of women who performed pelvic floor exercises at 6 weeks.

  6 weeks

Study Arms (2)

pelvic floor muscle exercises

ACTIVE COMPARATOR

Exercises were taught in the supine position, as described by Kegel (1948), and it was confirmed that the women learned to use the correct muscles with vaginal palpation. During the exercise, the participants were informed not to pull the abdomen inwards, not to tighten their legs and hip muscles, and not move their pelvis.

Behavioral: pelvic floor muscle exercises

diaphragmatic breathing exercises

ACTIVE COMPARATOR

Diaphragmatic breathing exercise was taught in supine position. The movement of the symphysis pubis was examined to confirm that the pelvic floors' movement was also involved breathing. Abdominal palpation was used to elicit unawareness of the diaphragmatic breathing and to assess whether contractions were performed correctly.

Behavioral: diaphragmatic breathing exercises

Interventions

pelvic floor muscle exercises BEHAVIORAL

During the first visit, the anatomy of the pelvic floor and the purpose of the program were explained. Exercises were taught in the supine position, as described by Kegel (1948), it was confirmed that the women learned to use the correct muscles with vaginal palpation. During the exercise, the participants were informed not to pull the abdomen inwards, not to tighten their legs and hip muscles, and not move their pelvis.

pelvic floor muscle exercises

diaphragmatic breathing exercises BEHAVIORAL

During the first visit, the anatomy of the diaphragm and abdominal wall and the purpose of the program were explained. Diaphragmatic breathing exercise was taught in supine position. The movement of the symphysis pubis was examined to confirm that the pelvic floors' movement was also involved breathing. Abdominal palpation was used to elicit unawareness of the diaphragmatic breathing and to assess whether contractions were performed correctly.

diaphragmatic breathing exercises

Eligibility Criteria

• Age: 19 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of urinary incontinence
• Urinary leakage at least 3 months
• Not received physiotherapy before

You may not qualify if:

• Pregnancy
• Postpartum period (6 weeks after delivery)
• Detrusor hyperreflexia
• Menopause
• Hormonal therapy
• Active vaginal lesion or infection
• Urinary infection
• Prior pelvic surgery
• Organ prolapse
• Chronic pelvic pain
• Sexual disorders
• Neurological problem

Sponsors & Collaborators

• selva sen: lead

Study Sites (1)

Istanbul Medipol Universty

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

• 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: 35248263 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants were randomized into two groups: pelvic floor muscle exercises (Group PFM n=20) and diaphragmatic breathing exercises (Group DB n=20). Exercise programs consisted of 1 set of contractions per day and each set included 30 repetitions for 6 weeks. Women were asked to complete forms of Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6), Incontinence Quality of Life (I-QOL), and Overactive Bladder (OAB-V3) before starting the program and again at the end of the 6-week program. Changes from baseline were compared in both groups and between the two groups.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 5, 2021
• Study Start: December 1, 2018
• Primary Completion: January 16, 2019
• Study Completion: June 1, 2019
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)