Female Sexual Dysfunctions in Chronic Kidney Disease

March 30, 2018 updated by: Esraa Ahmed Mohamed, Assiut University

Sexual Dysfunctions in Female Patients With Chronic Kidney Disease

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.

Study Overview

Status

Unknown

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of female sexual dysfunctions in patients with chronic kidney disease.
Time Frame: one year
questionnaire to female patients with chronic kidney disease
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2018

Primary Completion (ANTICIPATED)

May 30, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (ACTUAL)

April 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • FSDCKD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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