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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05474495
• Other study ID #: REC/RCR & AHS/22/0533
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 10, 2022

Study information

• Verified date: December 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 10, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Disability Physical
• Enuresis
• Prolapse
• Urinary Incontinence

Intervention

Other:
• Pelvic floor muscle training
Pelvic floor muscle training. Two sessions a week for 6 weeks, each session lasting 45 mins.
• Transverse abdominas strength training
Transverse abdominas strength training will be given 5 days a week and continued for 6 weeks.

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital,	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 Weeks
Primary	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.	6 Weeks