Clinical trial NCT05474495: 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
Overall status: COMPLETED
Phase: NA
Conditions: Disability Physical
Urinary Incontinence
Prolapse
Keywords: Cystocele
Disability
Pelvic Floor Prolapse
Urinary Incontinence
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pelvic Floor Disability Index
timeFrame: 6 Weeks
measure: Pelvic organ prolapse quantification (POP-Q)
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital,
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
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