Diaphragmatic Breathing Exercises on Urinary Incontinence

July 28, 2021 updated by: selva sen

The Role of Diaphragmatic Breathing Exercise on Urinary Incontinence Treatment: A Pilot Study

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.

Study Overview

Detailed Description

Urinary incontinence (UI) is a chronic condition with involuntary urine loss. Urgency urinary incontinence (UUI) is a complaint of involuntary loss of urine associated with urgency; stress urinary incontinence (SUI) is a complaint of involuntary urine leaks out on effort or physical exertion including sporting activities, or on sneezing or coughing. In the mixed type of urinary incontinence (MUI) complaints coexist both in stress and urgency.

Although urinary incontinence is not a life-threatening condition, the feeling of discomfort caused by constant wetness, irritation, and the fear of odor affects the daily and social activities of in patients.

The abdominal-pelvic cavity contains most of the internal organs, is bounded by the diaphragm above, abdominal muscles anterior and lateral, thoracolumbar fascia and dorsal muscles in the back, and pelvic floor in the lower part. The respiratory diaphragm forms the roof of the abdomina-pelvic cavity and the pelvic floor forms the base. The diaphragm is the main respiratory muscle, connected to the pelvic floor via the transversalis fascia. The pelvic floor supports internal organs, as well as constrictor and continence mechanisms of the urethral, anal and vaginal orifices in females.

Musculofascial support is provided by the pelvic floor forms a hammock onto which the urethra is compressed during increases in intra-abdominal pressure. When intraabdominal pressure increases, intra-abdominal contents downward momentum is arrested by stretch resistance of the pelvic floor structures. At this time, the proximal intraabdominal portion of the urethra is compressed against the underlying supporting layer, which consists of the endopelvic fascia, vagina, and pelvic floor.

Pelvic floor muscle (PFM) exercises, defined by Arnold H. Kegel, aims to regain support to the urinary organs by actively functioning the pelvic floor muscles. Previous researches show that PFM exercises are an effective treatment for UI and improve the quality of life (Qol) of in women. It is currently used as the first choice in conservative treatment of incontinence. However, PFM exercises may be encountered with some difficulties in order to understanding and performing by patients.

Talas et al. showed that the pelvic floor moves in the craniocaudal direction parallel to the diaphragm during respiration. In this study, they suggested that during expiration, the pelvic floor muscles contract together with the abdominal muscles, pushing the abdominal organs up, pushing the intra-abdominal pressure (IAP) to towards the diaphragm.

In this study, the investigators hypothesized that the patients can improve pelvic floor function by performing DB exercises, indirectly via the facial and functional connection between the diaphragm and PFM, and incontinence could be reduced.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34000
        • Istanbul Medipol Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pelvic floor muscle exercises
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.
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.
Active Comparator: diaphragmatic breathing exercises
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed diaphragmatic breathing exercises at 6 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed pelvic floor exercises at 6 weeks.
Time Frame: 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 pelvic floor exercises and again at the end of the 6-week program.
6 weeks
Change from baseline Urogenital Distress Inventory (UDI-6) scores of women who performed pelvic floor exercises at 6 weeks.
Time Frame: 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 pelvic floor exercises and again at the end of the 6-week program.
6 weeks
Change from baseline Incontinence Quality of Life (I-QOL) scores of women who performed pelvic floor exercises at 6 weeks.
Time Frame: 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 pelvic floor 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 pelvic floor exercises at 6 weeks.
Time Frame: 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 pelvic floor exercises and again at the end of the 6-week program.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

January 16, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence

Clinical Trials on pelvic floor muscle exercises

3
Subscribe