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

Primary Purpose

Disability Physical, Urinary Incontinence, Prolapse

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pelvic floor muscle training
Transverse abdominas strength training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disability Physical focused on measuring Cystocele, Disability, Pelvic Floor Prolapse, Urinary Incontinence

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jinnah Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pelvic floor muscle training

Transverse abdominas strength training

Arm Description

Experimental Group (Group A) will receive pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.

Active Comparator (Group B) will receive transverse abdominas strength training. Treatment will be given 5 days a week and continued for 6 weeks.

Outcomes

Primary Outcome Measures

Pelvic Floor Disability Index
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).
Pelvic organ prolapse quantification (POP-Q)
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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2022
Last Updated
December 13, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05474495
Brief Title
Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program In Patients With Grade 1 Cystocele
Official Title
Comparative 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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability Physical, Urinary Incontinence, Prolapse
Keywords
Cystocele, Disability, Pelvic Floor Prolapse, Urinary Incontinence

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training
Arm Type
Experimental
Arm Description
Experimental Group (Group A) will receive pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.
Arm Title
Transverse abdominas strength training
Arm Type
Active Comparator
Arm Description
Active Comparator (Group B) will receive transverse abdominas strength training. Treatment will be given 5 days a week and continued for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
Pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.
Intervention Type
Other
Intervention Name(s)
Transverse abdominas strength training
Intervention Description
Transverse abdominas strength training will be given 5 days a week and continued for 6 weeks.
Primary Outcome Measure Information:
Title
Pelvic Floor Disability Index
Description
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).
Time Frame
6 Weeks
Title
Pelvic organ prolapse quantification (POP-Q)
Description
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.
Time Frame
6 Weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females With Grade 1 Cystocele
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.Phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital,
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30614646
Citation
Muro S, Tsukada Y, Harada M, Ito M, Akita K. Anatomy of the smooth muscle structure in the female anorectal anterior wall: convergence and anterior extension of the internal anal sphincter and longitudinal muscle. Colorectal Dis. 2019 Apr;21(4):472-480. doi: 10.1111/codi.14549. Epub 2019 Jan 24.
Results Reference
background
PubMed Identifier
34575049
Citation
Roch M, Gaudreault N, Cyr MP, Venne G, Bureau NJ, Morin M. The Female Pelvic Floor Fascia Anatomy: A Systematic Search and Review. Life (Basel). 2021 Aug 30;11(9):900. doi: 10.3390/life11090900.
Results Reference
background
PubMed Identifier
31555847
Citation
Flusberg M, Kobi M, Bahrami S, Glanc P, Palmer S, Chernyak V, Kanmaniraja D, El Sayed RF. Multimodality imaging of pelvic floor anatomy. Abdom Radiol (NY). 2021 Apr;46(4):1302-1311. doi: 10.1007/s00261-019-02235-5.
Results Reference
background
PubMed Identifier
35333406
Citation
Stupart D, Pickles K, Briggs C. Anatomy of the vesicovaginal fascia and its relation to branches of the inferior hypogastric plexus. Clin Anat. 2022 Oct;35(7):855-860. doi: 10.1002/ca.23858. Epub 2022 Apr 2.
Results Reference
background
PubMed Identifier
30140597
Citation
Eid S, Iwanaga J, Oskouian RJ, Loukas M, Tubbs RS. Comprehensive Review of the Cardinal Ligament. Cureus. 2018 Jun 20;10(6):e2846. doi: 10.7759/cureus.2846.
Results Reference
background

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

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