- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04994041
Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
Comparison of Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Gujranwala, Punjab, Pakistan, 52250
- Genesis fitness centere
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Pelvic floor muscle plus adductor strengthening
pelvic floor muscle plus adductor strengthening
|
20 sessions of pelvic floor muscle strengthening plus adductor is strengthening
|
|
ACTIVE_COMPARATOR: Pelvic floor muscle exercises
pelvic floor muscle exercises
|
20 sessions of pelvic floor muscle strengthening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary Distress Inventory (UDI-6)
Time Frame: 8 weeks
|
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
|
|
The Revised Urinary Incontinence Scale (RUIS)
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Al-Mukhtar Othman J, Akervall 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/21/0415 Irum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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