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

Not Applicable

• Conditions: Urinary Incontinence; Urinary Tract Disorders
• Interventions: Procedure: Pelvic floor Physical Therapy; Procedure: Therapeutic Yoga Training

• Registration Number: NCT05253898
• Lead Sponsor: Hasan Kalyoncu University

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.

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-18
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-11
• Primary Completion: 2022-06-13
• Study Completion: 2022-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Physical Therapy	Pelvic floor Physical Therapy	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.
Therapeutic Yoga Training	Therapeutic Yoga Training	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.

Primary Outcome Measures

Name	Time	Method
İncontinence Questionary at 8 weeks	Change from Baseline in incontinence 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.
1 hour Pad Test	Change from Baseline in Pad Test at 8 weeks	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	Change from Baseline in State-Trait Anxiety Inventory at 8 weeks	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	Change from Baseline in Bladder Diary at 8 weeks	Bladder diary is used to asses lower urinary tract symptoms (LUTS).
Incontinence Severity Index	Change from Baseline in Incontinence Severity Index at 8 weeks	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	Change from Baseline in Incontinence Quality of Life at 8 weeks	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	Change from Baseline in Global Perception of Improvement at 8 weeks	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	Change from Baseline in PERFECT degrees at 8 weeks	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.

Trial Locations

Locations (1)

Special Nova Therapy and Rehabilitation Center; 🇹🇷 Diyarbakır, Turkey