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Completed

NCT Number: NCT05916820

Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence

Randomized clinical trial (RCT) will be conducted to compare the effects of Tanzberger exercises and pelvic floor muscle training on urinary incontinence and quality of life in post_menopausal females suffering from urine incontinence in which data will be collected from Razahat Medical Centre, Lahore via International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form score (ICIQ-UI-SF) and incontinence quality of life (IQOL) Questionnaire. Sample size of 34 patients will be taken. Non_probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the PFMs group or Tanzberger exercise group. Treatment will be given three times a week. International Consultation on Incontinence Questionnaire, Urinary Incontinence-Short Form Questionnaire and Incontinence quality of life will be used to measure quality of life. All participants in both groups will be evaluated before and after the treatment programs. Total duration of study will be six months. Data will be analyzed by using SPSS 21

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Key information

Conditions

Urinary Incontinence Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Menopause Mental Disorders Nocturnal Enuresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Razahat Medical Center,Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

Urinary Incontinence is defined by the International Continence Society (ICS) as the involuntary loss of urine through urethra which is distressing and disabling condition mainly affecting the social and psychological well-being of an individual. Due to the embarrassing nature of incontinence, it is both underreported and under diagnosed. It affects women's quality of life. Tanzberger technique using Swiss ball strengthen levator ani muscles which play role in closing urethra. Pelvic floor muscle exercises are safe and efficient treatment option to treat urinary incontinence and improves quality of life. The significance of this study is, PMFs training and Tanzberger exercises will be executed in comparison to treat post-menopausal women who are facing with unhygienic and social embarrassing health disorder of Urinary Incontinence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 45 to 60 years.
  • Postmenopausal Females
  • Diagnosed patients of urinary incontinence

Exclusion criteria

  • Delivery with any complication.
  • Females have any history of diabetes, hypertension, neurological, or any chronic illness.
  • Any pelvic or abdominal surgery
  • Disc herniation or spine fracture.

Treatment and study plan

Tanzberger Exercises

Other

It consists of patients who will receive Tanzberger exercise 3 sessions per week for 4 weeks. e.g. Rolling on the ball forward, Back to back sitting.

Pelvic Floor Muscle training

Other

It consists of patients who will pelvic floor muscles exercise 3 sessions per week for 4 weeks. e.g. Assisted heel drop, Bridge, Dead Bug, Bird DOG

Primary outcomes

  1. Incontinence Quality of life questionnaire

    Time frame: 4th week

    The I-QoL Questionnaire consists of 22 questions that assess the limitations on human behavior, the psychosocial impact and social constraint brought about by urinary incontinence. Responses are given on a scale ranging from 1 to 5 points and the final scores are then summed up and converted into percentages. The higher the percentage, the better the quality of life. Reliability was assessed by Cronbach's alpha(0.93)

  2. International Consultation on Incontinence Questionnaire-Urinary Incontinence

    Time frame: 4th week

    The ICIQ-UI-SF measures the degree of urinary incontinence and gives it a score on a range of 0 - 21, where higher numbers in any part indicate a worse urinary incontinence. This questionnaire examines the frequency, amount and duration of urine leakage and its effect on the quality of life. Numerous studies used this tool and its reliability and validity were confirmed in Iran with a Cronbach's alpha of 0.75

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Tanzberger Versus Pelvic Floor Muscle Training on Urinary Incontinence and Quality of Life in post_menopausal Females

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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