Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence

Urinary Incontinence Clinical Trial

Official title:

Comparison of Group-based Pelvic Floor Physical Therapy and Therapeutic Yoga for Postnatal Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05253898
• Other study ID #: 2021/005
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: January 2022
• Source: Hasan Kalyoncu University
• Contact: Aysenur Tuncer, PT, PhD
• Phone: +90-342 2118080
• Email: aysenur.tuncer[@]hku.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 15, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urologic Diseases

Intervention

Procedure:
• Pelvic floor Physical Therapy
Purpose of pelvic floor muscle education program is reduce the symptoms of stress urinary incontinence and improving quality of life.
• Therapeutic Yoga Training
Purpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life.

Locations

Country	Name	City	State
Turkey	Special Nova Therapy and Rehabilitation Center	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence Questionary at 8 weeks	Incontinence 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.	Change from Baseline in incontinence questionary at 8 weeks
Primary	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.	Change from Baseline in Incontinence Severity Index at 8 weeks
Primary	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).	Change from Baseline in Incontinence Quality of Life at 8 weeks
Primary	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.	Change from Baseline in Global Perception of Improvement at 8 weeks
Primary	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.	Change from Baseline in PERFECT degrees at 8 weeks
Primary	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.	Change from Baseline in Pad Test at 8 weeks
Primary	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.	Change from Baseline in State-Trait Anxiety Inventory at 8 weeks
Primary	Bladder Diary	Bladder diary is used to asses lower urinary tract symptoms (LUTS).	Change from Baseline in Bladder Diary at 8 weeks