Back to resultsComparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence
Primary Purpose
Urinary Incontinence, Urinary Tract Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic floor Physical Therapy
Therapeutic Yoga Training
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary incontinence, Postnatal, Yoga, Pelvic floor muscle, Rehabilitation, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Women ages between 18 and 50 years old,
- Women who have SUI 45 days and above after giving birth
- Patients who accept to join the group sessions and will participate regularly in the treatment program
Exclusion Criteria:
- Women who have pelvic organ prolapsus and fecal incontinence
- Women who have undergone surgery for the lower urinary system
- Those who receive medication treatment for incontinence in the last 3 months
- Those with acute infection and bladder stones or tumors will not be included in the study.
Sites / Locations
- Special Nova Therapy and Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pelvic Floor Physical Therapy
Therapeutic Yoga Training
Arm Description
Group 1 includes a training program about correctly using pelvic floor muscles. At the first session, an educational program will be given to all women about the anatomy and function of the pelvic floor muscles. Then, the pelvic floor muscles contractions will be controlled by vaginal palpation for approximately 10 minutes. Then it will follow with 5 minutes of warm-up exercises, 30 minutes of fast and slow pelvic floor muscles contractions in different positions, and 10 minutes of abdominal breathing, general relaxation, stretching, and cool-down exercises. It is planned to teach contractions with internal palpation for 10 minutes before the first session to ensure that the patients' pelvic floor contractions are performed correctly. PFT treatment will be given as two sessions per week, 45 minutes, and 8 weeks as group sessions.
Group 2 program includes therapeutic yoga training. It will begin with education about the positive effects of yoga on the body and pelvic floor. Then it will follow with 5 minutes of warm-up exercises, 30 minutes of different asanas coordinated with breathing, and 10 minutes of yogi breathing and cool-down exercises. Also, a home exercise program will be given based on yoga sessions. Participants will receive a detailed description of the home program.
Outcomes
Primary Outcome Measures
İncontinence Questionary at 8 weeks
İncontinence Questionary-3 (3IQ) is a simple questionnaire to categorize the type of urinary incontinence.
First question evaluates the existence of incontinence in the past 3 months. Second and third questions are directed to familiarity and the existence of the types of incontinence.
The 3IQ is a quick test to evaluate the types of urinary incontinence with high sensitivity especially for stress urinary incontinence.
Incontinence Severity Index
Incontinence Severity Index (ISI) is a tool for assessing the severity of female urinary incontinence. ISI is consists of 2 questions to establish frequency and amount of leakage. The results categorize the severity into 4 as; slight, moderate, severe, and very severe.
Incontinence Quality of Life
Incontinence Quality of Life (I-QoL) is used for assessing the decrease of quality of life depending on urinary incontinence symptoms. I-QoL consists of 22 questions and results with 4 domains. I-QoL has identified the 3 factors; avoidance and limiting behavior (8 items), psychosocial impacts (9 items), and social embarrassment (5 items).
Global Perception of Improvement
Global Perception of Improvement (GPI) is used for showing the individual improvement of healing depending patient's perspective. GPI is rated to the satisfaction of advancement depending on the treatment for patients. Patients rated themselves as much better, better, about the same, worse, and much worse.
Pelvic Floor Muscle Strength assessing with PERFECT
PERFECT is used to assess pelvic floor muscle power, endurance, maximal repetitions, and the number of fast contractions by using internal digital palpation.
(P) symbolizes the power and this value is identified with modified oxford Scale during max. volunteer contraction.
(E) symbolizes the endurance and it's identified by how much time will continue the max. volunteer contraction.
(R) symbolizes the repetitions and it's identified with the number of maximum volunteer contractions, between each contraction, must be 4 s resting time.
(F) symbolizes the fast and it's identified the number of fast contractions.
(ECT) symbolizes every contraction time which means recording all numbers and times during evaluation.
1 hour Pad Test
Pad test is an objective way to scale the amount of incontinence in a specific time and the same conditions. The test begins with drinking 500ml water and 30 minutes sitting, then equal repetitions of jumping, walking, coughing, bending down, and washing hands-on running water for each patient.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI) form consist of 2 different tool. STAI-I examines the current anxiety level, and STAI-II examines the aspects of anxiety proneness general states of calmness and confidence. STAI-I consist of 20 questions about how person feel during the test. STAI-II consist of 20 questions about continues anxiety level.
Bladder Diary
Bladder diary is used to asses lower urinary tract symptoms (LUTS).
Secondary Outcome Measures
Full Information
NCT ID
NCT05253898
First Posted
February 15, 2022
Last Updated
February 24, 2022
Sponsor
Hasan Kalyoncu University
1. Study Identification
Unique Protocol Identification Number
NCT05253898
Brief Title
Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence
Official Title
Comparison of Group-based Pelvic Floor Physical Therapy and Therapeutic Yoga for Postnatal Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
June 13, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
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 aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).
Detailed Description
32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order.
Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2.
PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes.
TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Tract Disorders
Keywords
Urinary incontinence, Postnatal, Yoga, Pelvic floor muscle, Rehabilitation, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pelvic Floor Physical Therapy
Arm Type
Active Comparator
Arm Description
Group 1 includes a training program about correctly using pelvic floor muscles. At the first session, an educational program will be given to all women about the anatomy and function of the pelvic floor muscles. Then, the pelvic floor muscles contractions will be controlled by vaginal palpation for approximately 10 minutes.
Then it will follow with 5 minutes of warm-up exercises, 30 minutes of fast and slow pelvic floor muscles contractions in different positions, and 10 minutes of abdominal breathing, general relaxation, stretching, and cool-down exercises.
It is planned to teach contractions with internal palpation for 10 minutes before the first session to ensure that the patients' pelvic floor contractions are performed correctly. PFT treatment will be given as two sessions per week, 45 minutes, and 8 weeks as group sessions.
Arm Title
Therapeutic Yoga Training
Arm Type
Active Comparator
Arm Description
Group 2 program includes therapeutic yoga training. It will begin with education about the positive effects of yoga on the body and pelvic floor.
Then it will follow with 5 minutes of warm-up exercises, 30 minutes of different asanas coordinated with breathing, and 10 minutes of yogi breathing and cool-down exercises.
Also, a home exercise program will be given based on yoga sessions. Participants will receive a detailed description of the home program.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor Physical Therapy
Intervention Description
Purpose of pelvic floor muscle education program is reduce the symptoms of stress urinary incontinence and improving quality of life.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Yoga Training
Intervention Description
Purpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life.
Primary Outcome Measure Information:
Title
İncontinence Questionary at 8 weeks
Description
İncontinence Questionary-3 (3IQ) is a simple questionnaire to categorize the type of urinary incontinence.
First question evaluates the existence of incontinence in the past 3 months. Second and third questions are directed to familiarity and the existence of the types of incontinence.
The 3IQ is a quick test to evaluate the types of urinary incontinence with high sensitivity especially for stress urinary incontinence.
Time Frame
Change from Baseline in incontinence questionary at 8 weeks
Title
Incontinence Severity Index
Description
Incontinence Severity Index (ISI) is a tool for assessing the severity of female urinary incontinence. ISI is consists of 2 questions to establish frequency and amount of leakage. The results categorize the severity into 4 as; slight, moderate, severe, and very severe.
Time Frame
Change from Baseline in Incontinence Severity Index at 8 weeks
Title
Incontinence Quality of Life
Description
Incontinence Quality of Life (I-QoL) is used for assessing the decrease of quality of life depending on urinary incontinence symptoms. I-QoL consists of 22 questions and results with 4 domains. I-QoL has identified the 3 factors; avoidance and limiting behavior (8 items), psychosocial impacts (9 items), and social embarrassment (5 items).
Time Frame
Change from Baseline in Incontinence Quality of Life at 8 weeks
Title
Global Perception of Improvement
Description
Global Perception of Improvement (GPI) is used for showing the individual improvement of healing depending patient's perspective. GPI is rated to the satisfaction of advancement depending on the treatment for patients. Patients rated themselves as much better, better, about the same, worse, and much worse.
Time Frame
Change from Baseline in Global Perception of Improvement at 8 weeks
Title
Pelvic Floor Muscle Strength assessing with PERFECT
Description
PERFECT is used to assess pelvic floor muscle power, endurance, maximal repetitions, and the number of fast contractions by using internal digital palpation.
(P) symbolizes the power and this value is identified with modified oxford Scale during max. volunteer contraction.
(E) symbolizes the endurance and it's identified by how much time will continue the max. volunteer contraction.
(R) symbolizes the repetitions and it's identified with the number of maximum volunteer contractions, between each contraction, must be 4 s resting time.
(F) symbolizes the fast and it's identified the number of fast contractions.
(ECT) symbolizes every contraction time which means recording all numbers and times during evaluation.
Time Frame
Change from Baseline in PERFECT degrees at 8 weeks
Title
1 hour Pad Test
Description
Pad test is an objective way to scale the amount of incontinence in a specific time and the same conditions. The test begins with drinking 500ml water and 30 minutes sitting, then equal repetitions of jumping, walking, coughing, bending down, and washing hands-on running water for each patient.
Time Frame
Change from Baseline in Pad Test at 8 weeks
Title
State-Trait Anxiety Inventory
Description
State-Trait Anxiety Inventory (STAI) form consist of 2 different tool. STAI-I examines the current anxiety level, and STAI-II examines the aspects of anxiety proneness general states of calmness and confidence. STAI-I consist of 20 questions about how person feel during the test. STAI-II consist of 20 questions about continues anxiety level.
Time Frame
Change from Baseline in State-Trait Anxiety Inventory at 8 weeks
Title
Bladder Diary
Description
Bladder diary is used to asses lower urinary tract symptoms (LUTS).
Time Frame
Change from Baseline in Bladder Diary at 8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women ages between 18 and 50 years old,
Women who have SUI 45 days and above after giving birth
Patients who accept to join the group sessions and will participate regularly in the treatment program
Exclusion Criteria:
Women who have pelvic organ prolapsus and fecal incontinence
Women who have undergone surgery for the lower urinary system
Those who receive medication treatment for incontinence in the last 3 months
Those with acute infection and bladder stones or tumors will not be included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysenur Tuncer, PT, PhD
Phone
+90-342 2118080
Email
aysenur.tuncer@hku.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Nergiz Sayin, PT
Email
nergizsyn@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer, PT, PhD
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Special Nova Therapy and Rehabilitation Center
City
Diyarbakır
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nergiz Sayin, PT
12. IPD Sharing Statement
Learn more about this trial
Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence
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