Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management
Recruitment status was Active, not recruiting
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Purpose
This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.
| Condition |
|---|
|
Lower Urinary Tract Symptoms Gynecologic Malignancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management |
- The outcome will be measured using validated general and condition-specific questionnaires. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Have a diagnosis of a gynecologic malignancy: cervical, endometrial, or ovarian cancer, and plan to have surgry for the cancer treatment.
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
Contacts and Locations| United States, California | |
| University of California, Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Karen L Noblett, M.D. | University of California, Irvine |
More Information
No publications provided
| Responsible Party: | Karen Noblett, Associate Professor, University of California, Irvine Medical Center |
| ClinicalTrials.gov Identifier: | NCT00580697 History of Changes |
| Other Study ID Numbers: | 2006-4825 |
| Study First Received: | December 19, 2007 |
| Last Updated: | May 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Lower urinary tract symptoms Gynecologic malignancy Urinary incontinence Fecal incontinence |
Frequency Voiding dysfunction Sexual dysfunction |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013