Ignite Creation Date:
2024-05-06 @ 7:50 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02619552
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2015-10-28
Brief Title:
Impact of Medical Treatment on Sexual Function in Patients With Crohns Disease
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Impact of Medical Treatment on Sexual Function in Patients With Crohns Disease
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns 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 Crohns 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 patients 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 Crohns disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohns 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 Crohns disease Furthermore it would be the first study to evaluate the impact of medical therapy on sexual function
Previous studies have shown that sexual function is impaired in patients with Crohns 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 patients 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 Crohns disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohns 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 Crohns disease Furthermore it would be the first study to evaluate the impact of medical therapy on sexual function
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None