- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336865
Effect of Hormonal Contraception on Lower Urinary Tract Symptoms& Sexual Function
Study Overview
Status
Conditions
Detailed Description
It is generally accepted that female sex hormones influence the morphology and physiology of vaginal tissues. Peripheral estrogen affects urogenital connective tissue composition and structure, vaginal blood flow, and thickness of vaginal epithelium. Estrogen and progestagen receptors are also abundantly present in the lower urinary tract, which has the same embryonic origin as the vagina. decline in circulating estrogen levels may result in atrophy of vaginal, urethral and bladder trigonal epithelium, as well as initiate metabolic changes in the subepithelial supportive tissues. This process forms the biological rationale for the common clinical practice of prescribing hormone treatment to menopausal women with lower urinary and genital tract symptoms.
Contrary to widespread belief, the Womens Health Initiative (WHI) randomised trial showed that menopausal hormone therapy with conjugated estrogen alone, or in combination with progestagen, increased the risk of de novo or aggravated urinary incontinence after one year of treatment. In premenopausal women, oral contraception is the most common source of hormone intake but very few studies have endeavored to determine the effects of oral contraception on premenopausal urinary incontinence. The aim of this nationwide cohort study was to assess the influence of contraceptives on the risk for lower urinary tract dysfunction in young female.at is time-related with the beginning of hormonal contraception, health care providers should give information about other methods and try to switch them to a method less associated with sexual dysfunction. However, there are contradictory results between the different studies regarding the association between sexual dysfunction and hormonal contraceptives, so it could be firmly said that additional research is needed.
Meanwhile, it could be said that hormonal contraception has been associated with different alterations in sexual functioning.
To conclude, a multidisciplinary approach to the management of female sexual dysfunction is mandatory, and health care providers should give lifestyle counselling apart from proposing different treatment options. An adequate relationship with the patient, as well as the routine monitoring of possible sexual dysfunction, are essential in addressing these difficulties. Undoubtedly, the best contraceptive is one that fulfills the women's needs with acceptable side effects and agreed with the prescribed
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: randa habeeb yacoup
- Phone Number: +201278014811
- Email: randahabeb25@yahoo.com
Study Locations
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Assiut, Egypt
- Women"S Health Hospital
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Contact:
- ahmed makhlof
- Phone Number: +201001795011
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women taking hormonal contraception e.g cocs .pops.implanon&.injectable contraception
- Women has good regular marital life
Exclusion Criteria:
- female has organic urinary dysfunction
- female has mental& psycological dysfunction
- chronic disease DM.hypertension. chronic renal disease
- prolapse
- previous perineal &vaginal correlation surgery
- women taking any treatment for urinary tract infection &sexual dysfunction
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arabic female sexual function index
Time Frame: baseline
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valid questionnaire that can be used in the Egyptian population.
The questionnaire is relatively easy to be understood by lay women and does not contain unacceptably sexually explicit questions, which may pose difficulties for self-rating.
ArFSf I is valid and reliable,and it is as good as the original FSFI in assessing female sexual function &good psychometric tool for sexual dysfunction .
Research in the area of female sexuality is not easy and relatively challenging in the Arab world
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baseline
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Bristol female lower urinary tract symptoms questionnaire
Time Frame: baseline
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it was designed to asses lower urinary tract symptoms in women & quality of sexual life .
it will be translated into arabic language
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: muhmoud zakhera, Assiut University
- Study Chair: mostafa bahlool, Assiut University
Publications and helpful links
General Publications
- Batra SC, Iosif CS. Progesterone receptors in the female lower urinary tract. J Urol. 1987 Nov;138(5):1301-4. doi: 10.1016/s0022-5347(17)43588-9.
- Champaneria R, D'Andrea RM, Latthe PM. Hormonal contraception and pelvic floor function: a systematic review. Int Urogynecol J. 2016 May;27(5):709-22. doi: 10.1007/s00192-015-2833-3. Epub 2015 Sep 25.
- de Castro Coelho F, Barros C. The Potential of Hormonal Contraception to Influence Female Sexuality. Int J Reprod Med. 2019 Mar 3;2019:9701384. doi: 10.1155/2019/9701384. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- hormonal contraception
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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