Female Sexual Dysfunctions in Chronic Kidney Disease

NCT ID: NCT03485261

Last Updated: 2018-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group A

patient group include 50 female patients with chronic renal failure (eGFR \<15ml/min/1.7m2 )

No interventions assigned to this group

Group B

the control group including 50 healthy females age matched with the patient group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Ahmed Mohamed

eamohamed

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Esraa Ahmed Mohamed

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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ahmed samir, huxband

Role: primary

01150730888

Other Identifiers

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FSDCKD

Identifier Type: -

Identifier Source: org_study_id

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