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

NCT ID: NCT05474495

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-08-10

Brief Summary

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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

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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.

Conditions

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Disability Physical Urinary Incontinence Prolapse

Keywords

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Cystocele Disability Pelvic Floor Prolapse Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Pelvic floor muscle training

Intervention Type OTHER

Pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.

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.

Group Type ACTIVE_COMPARATOR

Transverse abdominas strength training

Intervention Type OTHER

Transverse abdominas strength training will be given 5 days a week and continued for 6 weeks.

Interventions

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Pelvic floor muscle training

Pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.

Intervention Type OTHER

Transverse abdominas strength training

Transverse abdominas strength training will be given 5 days a week and continued for 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabiha Arshad, M.Phil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Jinnah Hospital,

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 30614646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34575049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31555847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35333406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30140597 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/22/0533

Identifier Type: -

Identifier Source: org_study_id