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

NCT02619552 | Completed

• 1 other identifier: HP-00050472
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Crohn's Disease; IBD

Outcome Measures

Primary Outcomes (6)

• Assessment of Sexual Function

  Sexual Function Questionnaire

  6 months

• Assessment of Disease Activity

  Harvey Bradshaw Index

  6 months

• Assessment of Quality of Life

  Short Inflammatory Bowel Disease Questionnaire

  6 months

• Assessment of Body Image

  Body Image Scale

  6 months

• Assessment of Depression

  PHQ 9

  6 months

• Assessment of Perianal Disease Activity

  Perianal Disease Activity Index

  6 months

Study Arms (3)

Anti-TNF (Remicade, Humira or Cimzia) for luminal CD

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.

Drug: Anti-TNF

Anti-TNF (Remicade, Humira or Cimzia)for perianal CD

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.

Drug: Anti-TNF

Steroid (Prednisone or budesonide) for luminal CD

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.

Drug: Steroids

Interventions

Anti-TNF DRUG

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.

Also known as: Remicade, Humira, Cimzia

Anti-TNF (Remicade, Humira or Cimzia) for luminal CD

Steroids DRUG

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.

Also known as: Prednisone, Budesonide

Steroid (Prednisone or budesonide) for luminal CD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Vanderbilt University: collaborator
• Milton S. Hershey Medical Center: collaborator
• Mercy Medical Center: collaborator

Study Sites (4)

Mercy Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Location

Vanderbilt University

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab; Adalimumab; Certolizumab Pegol; Steroids; Prednisone; Budesonide

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Pregnenediones; Pregnenes

Study Officials

• Raymond Cross, MD, MS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: December 2, 2015
• Study Start: August 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2019
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

US (4)