Female Sexual Dysfunctions in Chronic Kidney Disease

NCT03485261 | Unknown DMC

• 1 other identifier: FSDCKD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• evaluation of female sexual dysfunctions in patients with chronic kidney disease.

  questionnaire to female patients with chronic kidney disease

  one year

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Esraa Ahmed Mohamed

Asyut, 71621, Egypt

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: eamohamed

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 2, 2018
• Study Start: April 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: December 31, 2019
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

EG (1)