Effect of Hormonal Contraception on Lower Urinary Tract Symptoms& Sexual Function

April 6, 2020 updated by: randa habeeb yacoup, Assiut University
Effect of hormonal contraception on lower urinary tract symptoms& sexual function

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Assiut, Egypt
        • Women"S Health Hospital
        • Contact:
          • ahmed makhlof
          • Phone Number: +201001795011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

all women attending family planning clinic taking hormonal contraception

Description

Inclusion Criteria:

  1. Women taking hormonal contraception e.g cocs .pops.implanon&.injectable contraception
  2. Women has good regular marital life

Exclusion Criteria:

  1. female has organic urinary dysfunction
  2. female has mental& psycological dysfunction
  3. chronic disease DM.hypertension. chronic renal disease
  4. prolapse
  5. previous perineal &vaginal correlation surgery
  6. women taking any treatment for urinary tract infection &sexual dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
baseline
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: muhmoud zakhera, Assiut University
  • Study Chair: mostafa bahlool, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2020

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

October 15, 2021

Study Registration Dates

First Submitted

April 4, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • hormonal contraception

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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