Clinical trial NCT03485261: Female Sexual Dysfunctions in Chronic Kidney Disease
Official title: Sexual Dysfunctions in Female Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: evaluation of female sexual dysfunctions in patients with chronic kidney disease.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Esraa Ahmed Mohamed
Study officials:
References: