Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence

• Sponsor: Riphah International University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05916820
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.7
• Patients Per Site Per Month: 4.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence; Menopause	Other: Tanzberger Exercises; Other: Pelvic floor muscle training	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effects of Tanzberger Versus Pelvic Floor Muscle Training on Urinary Incontinence and Quality of Life in post_menopausal Females
• Actual Study Start Date: Dec 25, 2022
• Anticipated Primary Completion Date: Jul 25, 2023
• Anticipated Study Completion Date: Aug 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incontinence Quality of life questionnaire [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Razahat Medical Center,Lahore	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

• Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05916820
• Other Study ID Numbers: Iqra Shafi
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: Pelvic floor muscle training; Tanzberger Exercise; Urine Incontinence
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis

Study Results

No Results Posted as of Jun 23, 2023