An observational study in Crohn's Disease, Peri-anal Fistulas and Sexual Dysfunction, sponsored by University of British Columbia. Withdrawn at 1 site in Canada. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-10-18.
Sponsored by University of British Columbia · Observational
Objective:
The aim of this study is to investigate whether Crohn's Disease patients with peri-anal fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's Disease patients that would benefit from sexual health interventions.
Hypothesis:
Crohn's patients with active perianal fistulas will have decreased sexual drive, performance, and satisfaction than those with Crohn's Disease in remission.
Subject Selection:
Inclusion Criteria Patients in a stable sexual relationship between the ages of 19 and 70 of both sexes with Crohn's disease, as diagnosed based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months will be included in this study. Patients included in this study will have been sexually active in the last 4 weeks.
Exclusion Criteria All patients with known depression will be excluded from the study to prevent confounding the findings.
Patients that qualify for the study will be recruited, and be divided into inactive Crohn's Disease group with no peri-anal fistulas as a control group and an active Crohn's Disease with peri-anal fistula as the study group. Inactive Crohn's Disease patients will be defined as patients with Harvey-Bradshaw scores below 5. Fistula patients will be defined as patients with single or multiple draining fistulas, including perianal fistulas and enterocutaneous fistulas, for at least three months (17).
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
Browse Crohn Disease studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men and women ages 19-70 years old with Crohn's disease and sexually active in the last 4 weeks.
Exclusion Criteria:
Identifying Crohn's Disease patients with peri-anal fistulas and suffering from sexual dysfunction.
CD patients without perianal fistulas will be compared with CD patients with perianal fistulas in terms of the percentage of patients that exhibit our definition of sexual dysfunction.
Student t-test will be used to compare the difference between the fistula versus the control group. Statistical analysis will be two tailed and our p value will be set up as p \<0.05. We estimate that 30% of patients with CD will have sexual dysfunction, and that 65% of CD patients with peri-anal fistulas will have sexual dysfunction. Therefore, our calculated sample size for both groups will be around 31 patients each for 80% power with an alpha of 0.05.
Time frame: 1.5 years
This study is withdrawn, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of British Columbia