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

NCT03547596 | Unknown

• 1 other identifier: PO18063
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms; Erectile Dysfunction; Obstructive Sleep Apneas Syndrom

Keywords

Lower urinary tract symptoms; Erectile dysfunction; Obstructive Sleep Apneas Syndrom

Outcome Measures

Primary Outcomes (2)

• lower urinary tract symptoms

  Evaluation of the lower urinary tract symptoms using "UrinarySymptom Profil"

  Day 0

• erectile dysfunction

  Evaluation of the lower urinary tract symptoms using "International Index of Erectile Function"

  Day 0

Interventions

questionnaire passation OTHER

Questionnaires to evaluate lower urinary tract symptoms and erectile dysfunction.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Priscilla LEON

CONTACT

03 26 78 73 47; pleon@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: April 29, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2020
• Last Updated: December 4, 2018

Record last verified: 2018-05

Locations

FR (1)