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Diaphragmatic Breathing Exercises on Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pelvic floor muscle exercises
diaphragmatic breathing exercises
Sponsored by
selva sen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence focused on measuring Diaphragmatic breathing exercise, Pelvic floor muscles exercises, Kegel exercise, Urinary incontinence, Physiotherapy

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pelvic floor muscle exercises

diaphragmatic breathing exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed pelvic floor 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 pelvic floor exercises and again at the end of the 6-week program.
Change from baseline Urogenital Distress Inventory (UDI-6) scores of women who performed pelvic floor 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 pelvic floor exercises and again at the end of the 6-week program.
Change from baseline Incontinence Quality of Life (I-QOL) scores of women who performed pelvic floor 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 pelvic floor exercises and again at the end of the 6-week program.
Change from baseline Overactive Bladder (OAB-V3) scores of women who performed pelvic floor 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 pelvic floor exercises and again at the end of the 6-week program.

Full Information

First Posted
July 2, 2021
Last Updated
July 28, 2021
Sponsor
selva sen
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1. Study Identification

Unique Protocol Identification Number
NCT04991675
Brief Title
Diaphragmatic Breathing Exercises on Urinary Incontinence
Official Title
The Role of Diaphragmatic Breathing Exercise on Urinary Incontinence Treatment: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
selva sen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Diaphragmatic breathing exercise, Pelvic floor muscles exercises, Kegel exercise, Urinary incontinence, Physiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pelvic floor muscle exercises
Arm Type
Active Comparator
Arm Description
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.
Arm Title
diaphragmatic breathing exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
pelvic floor muscle exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
diaphragmatic breathing exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed diaphragmatic breathing exercises at 6 weeks
Description
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.
Time Frame
6 weeks
Title
Change from baseline the Urogenital Distress Inventory (UDI-6) scores of women who performed diaphragmatic breathing exercises at 6 weeks
Description
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.
Time Frame
6 weeks
Title
Change from baseline The Incontinence Quality of Life (I-QOL) scores of women who performed diaphragmatic breathing exercises at 6 weeks
Description
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.
Time Frame
6 weeks
Title
Change from baseline Overactive Bladder (OAB-V3) scores of women who performed diaphragmatic breathing exercises at 6 weeks
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Incontinence Impact Questionnaire (IIQ-7) scores of women who performed pelvic floor exercises at 6 weeks.
Description
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.
Time Frame
6 weeks
Title
Change from baseline Urogenital Distress Inventory (UDI-6) scores of women who performed pelvic floor exercises at 6 weeks.
Description
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.
Time Frame
6 weeks
Title
Change from baseline Incontinence Quality of Life (I-QOL) scores of women who performed pelvic floor exercises at 6 weeks.
Description
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.
Time Frame
6 weeks
Title
Change from baseline Overactive Bladder (OAB-V3) scores of women who performed pelvic floor exercises at 6 weeks.
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul Medipol Universty
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35248263
Citation
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.
Results Reference
derived

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Diaphragmatic Breathing Exercises on Urinary Incontinence

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