This trial is active, not recruiting.

Conditions lower urinary tract symptoms, gynecologic malignancy
Sponsor University of California, Irvine
Start date January 2006
End date December 2010
Trial size 100 participants
Trial identifier NCT00580697, 2006-4825


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

The outcome will be measured using validated general and condition-specific questionnaires.
time frame: 7 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management
Principal investigator Karen L Noblett, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by University of California, Irvine.