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Female Sexual Dysfunctions in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03485261
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Esraa Ahmed Mohamed, Assiut University

Brief Summary:

A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual abnormalities are common in CKD and many women are an-ovulatory.

Sexual dysfunction in CKD is multifactorial including hormonal alterations along with vascular, neurologic, psychogenic, and other factors, such as medications, contribute to the development of sexual dysfunction. Sexual dysfunction in females is mainly due to hormonal factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal lubrication, and failure to conceive.


Condition or disease
Chronic Kidney Diseases

Detailed Description:

The study will be conducted on 100 female patients divided in to two equal group:

  1. Group A: The patient group include 50 female patients with chronic renal failure (eGFR <15ml/min/1.7m2 )
  2. Group B: The control group including 50 healthy females age matched with the patient group.

The Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.

Duration of chronic kidney disease, duration of dialysis ,number of sessions of dialysis per week, medical treatment, haemoglobin,creatinine level will be fulfilled.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Sexual Dysfunctions in Female Patients With Chronic Kidney Disease
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
Group A
patient group include 50 female patients with chronic renal failure (eGFR <15ml/min/1.7m2 )
Group B
the control group including 50 healthy females age matched with the patient group



Primary Outcome Measures :
  1. evaluation of female sexual dysfunctions in patients with chronic kidney disease. [ Time Frame: one year ]
    questionnaire to female patients with chronic kidney disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Probability Sample
Study Population

The study will be conducted on 100 female patients divided in to two equal group:

  1. Group A: The patient group include 50 female patients with chronic renal failure (eGFR <15ml/min/1.7m2 )
  2. Group B: The control group including 50 healthy females age matched with the patient group.

The Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.

Duration of chronic kidney disease, duration of dialysis, number of sessions of dialysis per week, medical treatment, haemoglobin, creatinine level will be fulfilled.

Criteria

Inclusion Criteria:

  • Female patients with chronic kidney disease stage 5 with estimated glomerular filtration rate (eGFR) <15 ml/min/1.7m2 using the equation of MDRD (modification of diet in renal disease) on dialysis or not.
  • Age from 18 to 45 years old.
  • Married.
  • Sexually active during the last 6 months.

Exclusion Criteria:

  • Pregnant women.
  • Other medical diseases (diabetes mellitus, coronary artery disease, neurological disorders and other systematic diseases).
  • Taking medications affect sexuality function e.g. antidepressant drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485261


Locations
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Egypt
Esraa Ahmed Mohamed Recruiting
Assiut, Egypt, 71621
Contact: ahmed samir, huxband    01150730888    drahmedsamir3344@yahoo.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Esraa Ahmed Mohamed, eamohamed, Assiut University
ClinicalTrials.gov Identifier: NCT03485261     History of Changes
Other Study ID Numbers: FSDCKD
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency