Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program In Patients With Grade 1 Cystocele

December 13, 2022 updated by: Riphah International University

Comparative Effects of Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program on Disability and Urinary Incontinence In Patients With Grade 1 Cystocele

Cystocele, a protrusion of the bladder, happens while the bladder descends into the vagina. There are more than one underlying causes for the development of cystocele ensuing in weak point of the muscles and the connective tissue surrounding the bladder and vagina.

This study will be a randomized clinical trial. After the department permission of physical therapy data will be collected from patient of Jinnah Hospital. Data will be collected before and after treatment. Randomization will be done by lottery method. Group A will be given pelvic floor strengthning exercises and goup B will be given transverse abdominas strengthning exercises. Each group will have 33 patients each. A 6-week physical therapy program will be planned. Group A will be given pelvic floor muscle strengthning exercise and the group B will given transverse abdominas exercises.Data will be entered and analysed by SPSS version 25.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cystocele, in any other case called a protrusion of the bladder, happens while the bladder descends into the vagina.The bladder bulges via the anterior wall of the vagina, with which it's miles anatomically related. There are more than one underlying causes for the development of cystocele ensuing in weak point of the muscles and the connective tissue surrounding the bladder and vagina. This study will be a randomized clinical trial. After the department permission of physical therapy data will be collected from patient of Jinnah Hospital. Data will be collected before and after treatment. Total sample size is 60. Non probability convenient sampling technique will be used. Randomization will be done by lottery method. Group A will be given pelvic floor strengthning exercises and goup B will be given transverse abdominas strengthning exercises. Each group will have 33 patients each. A 6-week physical therapy program will be planned. Group A will be given pelvic floor muscle strengthning exercise and the group B will given transverse abdominas exercises. Individual sessions will be held twice a week for 60 minutes each. Each meeting will include a theoretical portion of up to 10 minutes and a practical portion of roughly 50 minutes. Home plan will also be shared with them. Post treatment analysis will be done in order to find the effects of both regims. Data will be entered and analysed by SPSS version 25. The aim is to compare the effects of transversus abdominis and pelvic floor muscle strengthening exercise program on disability and urinary incontinence in patients with grade 1 cystocele.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Jinnah Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females age of 35 to 65 years will be included in our study.
  • Females who will not able to contract the Pelvic floor muscles
  • Female who hill have mixed urinary incontinence will be included in our study

Exclusion Criteria:

  • Females with malignancies will be excluded
  • Females with neurological issue will be excluded
  • Females who hill have untreated urinary tract infection will be excluded from our study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic floor muscle training
Experimental Group (Group A) will receive pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.
Other: Pelvic floor muscle training
Pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.
Active Comparator: Transverse abdominas strength training
Active Comparator (Group B) will receive transverse abdominas strength training. Treatment will be given 5 days a week and continued for 6 weeks.
Other: Transverse abdominas strength training
Transverse abdominas strength training will be given 5 days a week and continued for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Disability Index
Time Frame: 6 Weeks
The Pelvic Floor Disability index Questionnaire is a condensed version of the Pelvic Floor Distress Inventory (PFDI).The PFDI-20 has 20 items and 3 scales of your symptoms. All items use the following format with a response scale from 0 to 4. Scale Scores: Obtain the mean value of all of the answered items within the corresponding scale (possible value 0 to 4) and then multiply by 25 to obtain the scale score (range 0 to 100).
6 Weeks
Pelvic organ prolapse quantification (POP-Q)
Time Frame: 6 Weeks
It will be used for diagnostic purpose for prolapse and participants will only be considered as Grade 1 Cystocele on the basis of this tool. and it will also used to compare the Exercise effects on prolapse at the start and at the end of study. It uses objective and precise distance measurements to the reference point, the hymen. Cystocele and prolapse of the vagina from other causes is staged using POP-Q criteria and can range from good support (no descent into the vagina) reported as a POP-Q stage 0 or I to a POP-Q score of IV, which includes prolapse beyond the hymen. It also used to quantify the movement of other structures into the vaginal lumen and their descent.
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, M.phil, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 10, 2022

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/22/0533

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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