Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas

Crohn's Disease Clinical Trial

Official title:

Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01635543
• Other study ID #: H11-01890
• Status: Withdrawn
• Phase: N/A
• First received: June 27, 2012
• Last updated: October 16, 2013
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Fistula
• Peri-anal Fistulas
• Sexual Dysfunction

Locations

Country	Name	City	State
Canada	Gastroenterology Research Institute	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Ireland A, Jewell DP. Sulfasalazine-induced impotence: a beneficial resolution with olsalazine? J Clin Gastroenterol. 1989 Dec;11(6):711. — View Citation

Levi AJ, Fisher AM, Hughes L, Hendry WF. Male infertility due to sulphasalazine. Lancet. 1979 Aug 11;2(8137):276-8. — View Citation

McKee RF, Keenan RA. Perianal Crohn's disease--is it all bad news? Dis Colon Rectum. 1996 Feb;39(2):136-42. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Riba N, Moreno F, Costa J, Olive A. [Appearance of impotence in relation to the use of methotrexate]. Med Clin (Barc). 1996 Apr 13;106(14):558. Spanish. — View Citation

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. — View Citation

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. — View Citation

Sussman A, Leonard JM. Psoriasis, methotrexate, and oligospermia. Arch Dermatol. 1980 Feb;116(2):215-7. — View Citation

Thomas E, Koumouvi K, Blotman F. Impotence in a patient with rheumatoid arthritis treated with methotrexate. J Rheumatol. 2000 Jul;27(7):1821-2. — View Citation

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. — View Citation

Timmer A, Bauer A, Kemptner D, Fürst 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. — View Citation

Timmer A, Kemptner D, Bauer A, Takses A, Ott C, Fürst 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No