Clinical trial NCT02619552: Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
Official title: Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
IBD
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: Milton S. Hershey Medical Center
name: Mercy Medical Center
First posted: 2015-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators are planning a study with 60 experimental participants and 30 control participants. The investigators will recruit participants from multiple referral centers for IBD with an existing population of nearly 5,000 patients.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Sexual Function
timeFrame: 6 months
measure: Assessment of Disease Activity
timeFrame: 6 months
measure: Assessment of Quality of Life
timeFrame: 6 months
measure: Assessment of Body Image
timeFrame: 6 months
measure: Assessment of Depression
timeFrame: 6 months
measure: Assessment of Perianal Disease Activity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: University of Maryland, Baltimore
name: Raymond Cross, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: