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Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence

Primary Purpose

Urinary Incontinence, Menopause

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Tanzberger Exercises
Pelvic floor muscle training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Pelvic floor muscle training, Tanzberger Exercise, Urine Incontinence

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Razahat Medical Center,LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tanzberger Exercises

Pelvic floor muscle training

Arm Description

It consist of patients who will receive Tanzberger exercises 3 sessions per week for 4 weeks.

It consists of patients who will receive pelvic floor muscle training 3 sessions per week for 4 weeks.

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05916820
Brief Title
Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence
Official Title
Effects of Tanzberger Versus Pelvic Floor Muscle Training on Urinary Incontinence and Quality of Life in post_menopausal Females
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2022 (Actual)
Primary Completion Date
July 25, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Menopause
Keywords
Pelvic floor muscle training, Tanzberger Exercise, Urine Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tanzberger Exercises
Arm Type
Experimental
Arm Description
It consist of patients who will receive Tanzberger exercises 3 sessions per week for 4 weeks.
Arm Title
Pelvic floor muscle training
Arm Type
Experimental
Arm Description
It consists of patients who will receive pelvic floor muscle training 3 sessions per week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Tanzberger Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
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 Outcome Measure Information:
Title
Incontinence Quality of life questionnaire
Description
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)
Time Frame
4th week
Title
International Consultation on Incontinence Questionnaire-Urinary Incontinence
Description
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
Time Frame
4th week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeela Arif, MS
Phone
03320845723
Email
adeela.arif@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeela Arif, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Razahat Medical Center,Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeela Arif, Mphil
Phone
03320845723
Email
adeela.arif@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28523400
Citation
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.
Results Reference
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PubMed Identifier
32016335
Citation
Vaughan CP, Markland AD. Urinary Incontinence in Women. Ann Intern Med. 2020 Feb 4;172(3):ITC17-ITC32. doi: 10.7326/AITC202002040.
Results Reference
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Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence

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