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Clinical trial

Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease

Read time: 1 mins
Last updated:31st Jul 2011
Identifier: NCT02619552
Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects.

Previous studies have shown that sexual function is impaired in patients with Crohn's disease. It is likely that both the symptoms related to the disease, medications used to treat the disease, and surgery all impair sexual function in a variety of ways. For example, body image may be impaired, patients may be worried about bowel incontinence or unpleasant odors associated with diarrhea, patients may have significant pelvic pain secondary to perianal fistulas, or they may have painful intercourse from adjacent inflammation or scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual function is not known.

The investigators propose a 6 month study to compare sexual function before and after treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with steroids.

The investigators anticipate that the investigators will show that therapy with an anti TNF agent will result in a more rapid and greater return of sexual function than steroids. This information will be important to help counsel patients about the optimal treatment to begin for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate the impact of medical therapy on sexual function.

Study Type: Observational
Actual Enrollment: 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
Study Start Date: August 2011
Estimated Primary Completion Date: June 2018
Estimated Study Completion Date: June 2018

Groups and Cohorts:
- Anti-TNF (Remicade, Humira or Cimzia) for luminal CD
- Anti-TNF (Remicade, Humira or Cimzia)for perianal CD
- Steroid (Prednisone or budesonide) for luminal CD

Category Value
Date last updated at source 2018-02-05
Study type(s) Observational study
Expected enrolment 50
Study start date 2011-08-01
Estimated primary completion date 2018-06-01

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