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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04994041
Other study ID # REC/Lhr/21/0415 Irum
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2021
Est. completion date August 10, 2021

Study information

Verified date August 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stress incontinence is common form of urinary incontinence in females. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening.


Description:

Stress incontinence is common form of urinary incontinence in females. When it develops in gym doing women, it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening. The collected data will be entered in Statistical Package for the Social Sciences 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 10, 2021
Est. primary completion date August 10, 2021
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - Women aged 25-45 years of age - Engaged in gym exercises - Fulfilling signs and symptoms of stress incontinence Exclusion Criteria: - Pregnant females - Females having any history of trauma - Any neurological disorders affecting bowl bladder - Any malignancy in lower abdominal area

Study Design


Intervention

Other:
Pelvic floor muscle plus adductor strengthening
20 sessions of pelvic floor muscle strengthening plus adductor is strengthening
Pelvic floor muscle exercises
20 sessions of pelvic floor muscle strengthening

Locations

Country Name City State
Pakistan Genesis fitness centere Gujranwala Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Al-Mukhtar Othman J, Åkervall S, Milsom I, Gyhagen M. Urinary incontinence in nulliparous women aged 25-64 years: a national survey. Am J Obstet Gynecol. 2017 Feb;216(2):149.e1-149.e11. doi: 10.1016/j.ajog.2016.09.104. Epub 2016 Oct 6. — View Citation

de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19. — View Citation

Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766. — View Citation

Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642. — View Citation

Pizzoferrato AC, Fauconnier A, Fritel X, Bader G, Dompeyre P. Urethral Closure Pressure at Stress: A Predictive Measure for the Diagnosis and Severity of Urinary Incontinence in Women. Int Neurourol J. 2017 Jun;21(2):121-127. doi: 10.5213/inj.1732686.343. Epub 2017 Jun 21. — View Citation

Schneeweiss J, Koch M, Umek W. The human urinary microbiome and how it relates to urogynecology. Int Urogynecol J. 2016 Sep;27(9):1307-12. doi: 10.1007/s00192-016-2944-5. Epub 2016 Jan 25. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary Distress Inventory (UDI-6) It is 6 point scale No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4.
Add all scores and multiply by 6 then multiply by 25 for the scale score
The UDI-6 Total Score of 33.33 was determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women.
For UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms.
8 weeks
Primary The Revised Urinary Incontinence Scale (RUIS) It is a 5 point scale with each point contain 3 to 4option.
Possible score range of 0 - 16
A score of less than 4 indicates that the patient has no urinary incontinence
a score of 4-8 is considered mild.
a score of 9-12 is considered moderate.
a score of 13 or above is considered severe.
8 weeks
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