Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05916820
• Other study ID #: Iqra Shafi
• Status: Completed
• Phase: N/A
• Start date: December 25, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 15, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Menopause
• Urinary Incontinence

Intervention

Other:
• Tanzberger Exercises
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
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

Locations

Country	Name	City	State
Pakistan	Razahat Medical Center,Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Gonzalez Isaza P, Jaguszewska K, Cardona JL, Lukaszuk M. Long-term effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause. Int Urogynecol J. 2018 Feb;29(2):211-215. doi: 10.1007/s00192-017-3352-1. Epub 2017 May 18. — View Citation

Vaughan CP, Markland AD. Urinary Incontinence in Women. Ann Intern Med. 2020 Feb 4;172(3):ITC17-ITC32. doi: 10.7326/AITC202002040. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incontinence Quality of life questionnaire	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)	4th week
Primary	International Consultation on Incontinence Questionnaire-Urinary Incontinence	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	4th week