CClinicalTrials.gg
Status unknownNCT03485261Updated Apr 2, 2018

Female Sexual Dysfunctions in Chronic Kidney Disease

An observational study in Chronic Kidney Diseases, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-04-02.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Kidney Diseases
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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.

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

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.
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

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

    questionnaire to female patients with chronic kidney disease

    Time frame: one year

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03485261
Lead sponsor
Assiut University
Responsible party
Esraa Ahmed Mohamed (eamohamed, Assiut University) — Principal investigator
First posted
Apr 2, 2018
Start date
Apr 1, 2018 (estimated)
Primary completion
May 30, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Apr 2, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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