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

Completed

• Conditions: Crohn's Disease; IBD
• Interventions: Drug: Anti-TNF; Drug: Steroids

• Registration Number: NCT02619552
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Primary Completion: 2018-06
• Study Completion: 2019-07-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anti-TNF (Remicade, Humira or Cimzia) for luminal CD	Anti-TNF	All participants 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 (Remicade, Humira or Cimzia)for perianal CD	Anti-TNF	All participants 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.
Steroid (Prednisone or budesonide) for luminal CD	Steroids	All participants 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.

Primary Outcome Measures

Name	Time	Method
Assessment of Disease Activity	6 months	Harvey Bradshaw Index
Assessment of Quality of Life	6 months	Short Inflammatory Bowel Disease Questionnaire
Assessment of Body Image	6 months	Body Image Scale
Assessment of Perianal Disease Activity	6 months	Perianal Disease Activity Index
Assessment of Sexual Function	6 months	Sexual Function Questionnaire
Assessment of Depression	6 months	PHQ 9

Trial Locations

Locations (4)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States