Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Menopause
• Intervention / Treatment: Other: Tanzberger Exercises; Other: Pelvic floor muscle training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Razahat Medical Center,Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tanzberger Exercises; It consist of patients who will receive Tanzberger exercises 3 sessions per week for 4 weeks.	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.
Experimental: Pelvic floor muscle training; It consists of patients who will receive pelvic floor muscle training 3 sessions per week for 4 weeks.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Adeela Arif, MS, Riphah International University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2022
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; Tanzberger Exercise; Urine Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: Iqra Shafi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No