ContraceptionNCT04336865
Effect of Hormonal Contraception on Lower Urinary Tract Symptoms& Sexual Function
An observational study of Contraception, run by Assiut University at 1 site in Egypt.
Trial summary
Effect of hormonal contraception on lower urinary tract symptoms\& sexual function Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception
- How many people
- 177 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: all women attending family planning clinic taking hormonal contraception
Who may be able to join
- Women taking hormonal contraception e.g cocs .pops.implanon\&.injectable contraception
- Women has good regular marital life
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Effect of hormonal contraception on lower urinary tract symptoms\& sexual function
Read the 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
- Conditions
- Contraception
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic female sexual function index
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
Measured: baseline
Bristol female lower urinary tract symptoms questionnaire
it was designed to asses lower urinary tract symptoms in women \& quality of sexual life . it will be translated into arabic language
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, randa habeeb yacoup, Assiut University
- Investigators
- muhmoud zakhera, Study chair, Assiut Universitymostafa bahlool, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336865
- Sponsor's protocol ID
- hormonal contraception
- Status last verified
- Apr 2020
- First submitted
- 4 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 3669191Champaneria 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.
PubMed 26407563de 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.
PubMed 30941356
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hormonal Contraception on Lower Urinary Tract Symptoms& Sexual Function
- ClinicalTrials.gov ID
- NCT04336865
- Acronym / sponsor ID
- hormonal contraception
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of hormonal contraception on lower urinary tract symptoms\& sexual function
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- all women attending family planning clinic taking hormonal contraception
Key inclusion criteria (2 listed)
- Women taking hormonal contraception e.g cocs .pops.implanon\&.injectable contraception
- Women has good regular marital life
Key exclusion criteria (6 listed)
- female has organic urinary dysfunction
- female has mental\& psycological dysfunction
- chronic disease DM.hypertension. chronic renal disease
- prolapse
- previous perineal \&vaginal correlation surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arabic female sexual function index
Time frame: baseline
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
Bristol female lower urinary tract symptoms questionnaire
Time frame: baseline
it was designed to asses lower urinary tract symptoms in women \& quality of sexual life . it will be translated into arabic language
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 3669191Batra 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.
- Background: PubMed 26407563Champaneria 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.
- Background: PubMed 30941356de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
muhmoud zakhera study chair
Assiut University
mostafa bahlool study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact randa habeeb yacoup (+201278014811, randahabeb25@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic female sexual function index (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336865, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.