NCT04710238

Brief Summary

  1. 1.Study the prevalence of sexual dysfunction in male patients on hemodialysis aged 18-60 years (sexually active male) .
  2. 2.Study the effect of hemodialysis on the male patients sexual functions by measurement of serum prolactin and free testosterone levels.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

September 27, 2020

Last Update Submit

January 13, 2021

Conditions

Keywords

uremic hypogonadismfree testosterone levelserum prolactin

Outcome Measures

Primary Outcomes (1)

  • Study the prevalence of sexual dysfunction in male patients on hemodialysis .

    Knowning the degree of sexual dysfunctions prevalence in male patients on hemodialysis and evaluation of the associated factors of gonadal dysfunction in male patients on hemodialysis .

    base line

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale patients aged 18-60 (sexualy active males )
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

male patients that were diagnosed to be ESRD on hemodialysis , newly diagnosed and patients on chronic hemodialysis for years

You may qualify if:

  • Male patients.
  • ESRD on chronic hemodialysis with GFR lower than 15ml/min /1.73 m2
  • Age (18\_60)years old

You may not qualify if:

  • Diabetic patients . 3-hypertesive patients . 3-Patients with primary infertility before the event of ESRD and Starting dialysis.
  • Manifest hypothyroidism . 5-Patient with other causes that may lead to subfertility as varicocele . 6-patients with previous exposure to head and genital trauma , surgery or irradiation .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Palmer BF, Clegg DJ. Gonadal dysfunction in chronic kidney disease. Rev Endocr Metab Disord. 2017 Mar;18(1):117-130. doi: 10.1007/s11154-016-9385-9.

    PMID: 27586847BACKGROUND
  • Antonucci M, Palermo G, Recupero SM, Bientinesi R, Presicce F, Foschi N, Bassi P, Gulino G. Male sexual dysfunction in patients with chronic end-stage renal insufficiency and in renal transplant recipients. Arch Ital Urol Androl. 2016 Jan 14;87(4):299-305. doi: 10.4081/aiua.2015.4.299.

    PMID: 26766802BACKGROUND
  • Foulks CJ, Cushner HM. Sexual dysfunction in the male dialysis patient: pathogenesis, evaluation, and therapy. Am J Kidney Dis. 1986 Oct;8(4):211-22. doi: 10.1016/s0272-6386(86)80029-4.

    PMID: 3532769BACKGROUND
  • Fiuk JV, Tadros NN. Erectile dysfunction in renal failure and transplant patients. Transl Androl Urol. 2019 Apr;8(2):155-163. doi: 10.21037/tau.2018.09.04.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

ali setohy hussien, M.B.B.ch

CONTACT

Manal Elsayed Ez eldeen, prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician ,internal medicine departement , nephrology unite

Study Record Dates

First Submitted

September 27, 2020

First Posted

January 14, 2021

Study Start

February 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 28, 2022

Last Updated

January 14, 2021

Record last verified: 2021-01