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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619552
• Other study ID #: HP-00050472
• Status: Completed
• Start date: August 2011
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• IBD

Intervention

Drug:
• Anti-TNF
All participants in this arm receive an anti-TNF for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
• Anti-TNF
All participants in this arm receive an anti-TNF for the treatment of perianal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
• Steroids
All participants in this arm receive steroids for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Mercy Medical Center, Milton S. Hershey Medical Center, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Sexual Function	Sexual Function Questionnaire	6 months
Primary	Assessment of Disease Activity	Harvey Bradshaw Index	6 months
Primary	Assessment of Quality of Life	Short Inflammatory Bowel Disease Questionnaire	6 months
Primary	Assessment of Body Image	Body Image Scale	6 months
Primary	Assessment of Depression	PHQ 9	6 months
Primary	Assessment of Perianal Disease Activity	Perianal Disease Activity Index	6 months