NCT01635543

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

June 27, 2012

Last Update Submit

October 16, 2013

Conditions

Crohn's DiseasePeri-anal FistulasSexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    1.5 years

Study Arms (1)

Crohn's Disease with peri-anal fistulas

Identifying Crohn's Disease patients with peri-anal fistulas and suffering from sexual dysfunction.

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women ages 19-70 years old with Crohn's disease and sexually active in the last 4 weeks.

You may qualify if:

  • patients in a stable sexual relationship between 19-70 years old with Crohn's Disease
  • Crohn's disease diagnosis is based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months
  • Patients will have been sexually active in the last 4 weeks.

You may not qualify if:

  • All patients with known depression will be excluded from the study to prevent confounding the findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Research Institute

Vancouver, British Columbia, V6C 2K5, Canada

Location

Related Publications (17)

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    PMID: 10914881BACKGROUND

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    PMID: 8656751BACKGROUND

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    PMID: 2573629BACKGROUND

  • Levi AJ, Fisher AM, Hughes L, Hendry WF. Male infertility due to sulphasalazine. Lancet. 1979 Aug 11;2(8137):276-8. doi: 10.1016/s0140-6736(79)90292-7.

    PMID: 88609BACKGROUND

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    PMID: 7356357BACKGROUND

  • Farouk R, Pemberton JH, Wolff BG, Dozois RR, Browning S, Larson D. Functional outcomes after ileal pouch-anal anastomosis for chronic ulcerative colitis. Ann Surg. 2000 Jun;231(6):919-26. doi: 10.1097/00000658-200006000-00017.

    PMID: 10816636BACKGROUND

  • Timmer A, Bauer A, Kemptner D, Furst A, Rogler G. Determinants of male sexual function in inflammatory bowel disease: a survey-based cross-sectional analysis in 280 men. Inflamm Bowel Dis. 2007 Oct;13(10):1236-43. doi: 10.1002/ibd.20182.

    PMID: 17508419BACKGROUND

  • El-Tawil AM. Zinc deficiency in men with Crohn's disease may contribute to poor sperm function and male infertility. Andrologia. 2003 Dec;35(6):337-41. doi: 10.1046/j.0303-4569.2003.00588.x.

    PMID: 15018135BACKGROUND

  • Timmer A, Bauer A, Dignass A, Rogler G. Sexual function in persons with inflammatory bowel disease: a survey with matched controls. Clin Gastroenterol Hepatol. 2007 Jan;5(1):87-94. doi: 10.1016/j.cgh.2006.10.018.

    PMID: 17234557BACKGROUND

  • Moody G, Probert CS, Srivastava EM, Rhodes J, Mayberry JF. Sexual dysfunction amongst women with Crohn's disease: a hidden problem. Digestion. 1992;52(3-4):179-83. doi: 10.1159/000200951.

    PMID: 1459352BACKGROUND

  • Timmer A, Kemptner D, Bauer A, Takses A, Ott C, Furst A. Determinants of female sexual function in inflammatory bowel disease: a survey based cross-sectional analysis. BMC Gastroenterol. 2008 Oct 3;8:45. doi: 10.1186/1471-230X-8-45.

    PMID: 18834529BACKGROUND

  • Ogilvie JW Jr, Goetz L, Baxter NN, Park J, Minami S, Madoff RD. Female sexual dysfunction after ileal pouch-anal anastomosis. Br J Surg. 2008 Jul;95(7):887-92. doi: 10.1002/bjs.6072.

    PMID: 18551505BACKGROUND

  • McKee RF, Keenan RA. Perianal Crohn's disease--is it all bad news? Dis Colon Rectum. 1996 Feb;39(2):136-42. doi: 10.1007/BF02068066.

    PMID: 8620778BACKGROUND

  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

    PMID: 10782451BACKGROUND

  • Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.

    PMID: 14985485BACKGROUND

  • Feagins LA, Kane SV. Sexual and reproductive issues for men with inflammatory bowel disease. Am J Gastroenterol. 2009 Mar;104(3):768-73. doi: 10.1038/ajg.2008.90. Epub 2009 Feb 17.

    PMID: 19223893RESULT

  • Mekhjian HS, Switz DM, Melnyk CS, Rankin GB, Brooks RK. Clinical features and natural history of Crohn's disease. Gastroenterology. 1979 Oct;77(4 Pt 2):898-906.

    PMID: 381094RESULT

MeSH Terms

Conditions

Crohn DiseaseSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Brian Bressler, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 9, 2012

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

CA(1)