Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | August 2011 |
| End Date: | July 1, 2019 |
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.
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.
Inclusion Criteria:
- Diagnosis of Crohn's disease confirmed by standard criteria
- Active luminal Crohn's disease defined by an HBI score of >4 or with draining perianal
Crohn's disease a) Active perianal Crohn's disease defined a presence of draining
perianal fistula on physical exam19
- Patients with active luminal Crohn's disease must be initiating treatment with an
anti-TNF agent (Remicade, Humira, Cimzia, or Simponi) or a steroid (prednisone,
Entocort, or Uceris).
- Patients with active perianal disease must be initiating therapy with an anti-TNF
agent (Remicade, Humira, Cimzia, or Simponi).
- Can understand written instructions in English
Exclusion Criteria:
- Previous primary non-response to an anti-TNF
- Uncontrolled medical or psychiatric disease (a. Degenerative neurologic condition,
b.Unstable angina, c.Class III/IV congestive heart failure, d.Severe asthma or chronic
obstructive pulmonary disease, e.Symptomatic peripheral vascular disease, f. Chronic
renal insufficiency (creatinine > 2.0), g. Malignancy within the last 3 years
(excluding squamous or basal cell cancers of the skin), h. Poorly controlled
depression, mania, and schizophrenia, i. Active infection, j. Acquired
immunodeficiency syndrome)
- Inability to adhere to the protocol
- Need for imminent surgery other than an exam under anesthesia
- Under 18 years of age.
- Pregnancy
- Use of concurrent prednisone >30 mg per day in the anti-TNF groups
We found this trial at
4
sites
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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