Female Sexual Dysfunctions in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Sexual Dysfunctions in Female Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03485261
• Other study ID #: FSDCKD
• Status: Recruiting
• First received: March 27, 2018
• Last updated: March 30, 2018
• Start date: April 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: May 30, 2019
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Egypt	Esraa Ahmed Mohamed	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of female sexual dysfunctions in patients with chronic kidney disease.	questionnaire to female patients with chronic kidney disease	one year