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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00580697
Other study ID # 2006-4825
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 2006
Est. completion date March 2006

Study information

Verified date January 2021
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.


Description:

Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, is directly affected by gynecologic malignancies and the surgical and medical management of those malignancies. Increased risk of injury to the urinary tract is a recognized complication of surgical and medical therapy of gynecologic malignancies. To date, only a few studies have looked at the incidence of lower urinary tract symptoms at the time of diagnosis of gynecologic malignancy and prior to treatment, and there have been no published studies describing the incidence of sexual dysfunction at the time of diagnosis and prior to therapy of gynecologic malignancies. However, sexual dysfunction has been described in patients with urinary incontinence and pelvic organ prolapse and following surgery for incontinence and pelvic organ prolapse.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with a new diagnosis of gynecologic malignancy who plan to undergo surgical management, including cervical, endometrial, and ovarian cancer. Exclusion Criteria: - Subjects less than 18 years of age - Subjects unable to give informed consent

Study Design


Locations

Country Name City State
United States University of California, Irvine Medical Center Orange California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The outcome will be measured using validated general and condition-specific questionnaires. 7 months
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