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

February 24, 2022 updated by: Nergiz Sayın, Hasan Kalyoncu University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Diyarbakır, Turkey
        • Recruiting
        • Special Nova Therapy and Rehabilitation Center
        • Contact:
          • Nergiz Sayin, PT

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
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.
ACTIVE_COMPARATOR: 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.
Procedure: Therapeutic Yoga Training
Purpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
İncontinence Questionary at 8 weeks
Time Frame: 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.
Change from Baseline in incontinence questionary at 8 weeks
Incontinence Severity Index
Time Frame: 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.
Change from Baseline in Incontinence Severity Index at 8 weeks
Incontinence Quality of Life
Time Frame: 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).
Change from Baseline in Incontinence Quality of Life at 8 weeks
Global Perception of Improvement
Time Frame: 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.
Change from Baseline in Global Perception of Improvement at 8 weeks
Pelvic Floor Muscle Strength assessing with PERFECT
Time Frame: 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.
Change from Baseline in PERFECT degrees at 8 weeks
1 hour Pad Test
Time Frame: 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.
Change from Baseline in Pad Test at 8 weeks
State-Trait Anxiety Inventory
Time Frame: 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.
Change from Baseline in State-Trait Anxiety Inventory at 8 weeks
Bladder Diary
Time Frame: Change from Baseline in Bladder Diary at 8 weeks
Bladder diary is used to asses lower urinary tract symptoms (LUTS).
Change from Baseline in Bladder Diary at 8 weeks

Collaborators and Investigators

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

Sponsor

Hasan Kalyoncu University

Investigators

  • Study Director: Aysenur Tuncer, PT, PhD, Hasan Kalyoncu University

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)

January 18, 2022

Primary Completion (ANTICIPATED)

June 13, 2022

Study Completion (ANTICIPATED)

August 15, 2022

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (ACTUAL)

February 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/005

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.

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