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

NCT05474495 | Completed

• 1 other identifier: REC/RCR & AHS/22/0533
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability Physical; Urinary Incontinence; Prolapse

Keywords

Cystocele; Disability; Pelvic Floor Prolapse; Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Pelvic floor muscle training

EXPERIMENTAL

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

Transverse abdominas strength training

ACTIVE COMPARATOR

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

Interventions

Pelvic floor muscle training OTHER

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

Pelvic floor muscle training

Transverse abdominas strength training OTHER

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

Transverse abdominas strength training

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Females With Grade 1 Cystocele
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital,

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 30614646 BACKGROUND

• 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.

  PMID: 34575049 BACKGROUND

• 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.

  PMID: 31555847 BACKGROUND

• 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.

  PMID: 35333406 BACKGROUND

• 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.

  PMID: 30140597 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Prolapse; Cystocele

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Urinary Bladder Diseases; Pelvic Organ Prolapse

Study Officials

• Sabiha Arshad, M.Phil

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 26, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 10, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)