Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Treatment of Obstructive Sleep Apnea Syndrome by Continuous Positive Airway Pressure Equipment at Night on the Lower Urinary Tract Symptoms and the Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03547596
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

To treat lower urinary tract symptoms (LUTS) and erectile dysfunction (ED), we mainly have symptomatic drug treatments. Some patients are resistant to the treatments that we have or are forced to stop treatments because of side effects.

It would be interesting to focus on comorbidities and to evaluate whether it is possible to improve the urological symptoms by taking care the comorbidities, which would consist in an etiological treatment of the urological symptoms.

The aim of the study is to evaluate the evolution of low urinary tract disorders (LUTS) and erectile dysfunction (ED) in patients with obstructive sleep apnea syndrome (OSAS) following by continuous positive airway pressure equipment (CPAP) at night.

Participation in the study will be offered to all patients, men and women, consulting or hospitalized in the sleep unit of the department of pneumology CHU of Reims for a nocturnal ventilatory polygraphy or a polysomnography diagnostic of OSAS.

Men will complete three questionnaires about LUTS and DE, women one questionnaire about LUTS. The questionnaires will be completed twice, the first time when consulting at the sleep unit for nocturnal ventilatory polygraphy or a polysomnography diagnostic of OSAS ; the second time during the pneumology consultation three months later. We will compare the results between the questionnaires to assess whether OSAS equipment with CPAP has improved urologic symptoms.

If the management of OSAS allows an improvement of lower urinary tract disorders and / or an improvement of erectile dysfunction, these results would be interesting for the management of patients resistant to symptomatic drug treatments or to stop them because of iatrogenic side effects.

Etiological rather than symptomatic management would also have long-term benefits, both in improving the overall quality of life of the patient and in the medical and economic field.

It might be interesting to identify in urology consultation among patients consulting for LUTS or ED, patients at risk of presenting OSAS and referring them to a pulmonologist to manage OSAS if it exists, from the beginning of the urological care.


Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Erectile Dysfunction Obstructive Sleep Apneas Syndrom Other: questionnaire passation

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Treatment of Obstructive Sleep Apnea Syndrome by Continuous Positive Airway Pressure Equipment at Night on the Lower Urinary Tract Symptoms and the Erectile Dysfunction
Actual Study Start Date : April 29, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: questionnaire passation
    Questionnaires to evaluate lower urinary tract symptoms and erectile dysfunction.


Primary Outcome Measures :
  1. lower urinary tract symptoms [ Time Frame: Day 0 ]
    Evaluation of the lower urinary tract symptoms using "UrinarySymptom Profil"

  2. erectile dysfunction [ Time Frame: Day 0 ]
    Evaluation of the lower urinary tract symptoms using "International Index of Erectile Function"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years, men and women, managed in the sleep unit of Reims University Hospital for the realization of a nocturnal ventilatory polygraphy or polysomnography in search of an OSAS during the inclusion phase and accepting to participate in the study.
Criteria

Inclusion criteria :

  • managed at the sleep unit at Reims University Hospital for the diagnosis of sleep apnea syndrome by nocturnal airway polygraphy or polysomnography
  • major
  • accepting participation in the study (signed non-opposition form)

Exclusion criteria :

  • refusing to be included in the study
  • minors
  • not speaking French or not able to read (inability to complete the questionnaires specific to the study).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547596


Contacts
Layout table for location contacts
Contact: Priscilla LEON 03 26 78 73 47 ext 0033 pleon@chu-reims.fr

Locations
Layout table for location information
France
Damien JOLLY Recruiting
Reims, France
Contact: Priscilla LEON    03 26 78 73 47 ext 0033    pleon@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Layout table for additonal information
Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03547596     History of Changes
Other Study ID Numbers: PO18063
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:
Lower urinary tract symptoms
Erectile dysfunction
Obstructive Sleep Apneas Syndrom

Additional relevant MeSH terms:
Layout table for MeSH terms
Erectile Dysfunction
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Lower Urinary Tract Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Urological Manifestations