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WithdrawnNCT00580697Updated Jan 25, 2021

Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management

An observational study in Lower Urinary Tract Symptoms and Gynecologic Malignancy, sponsored by University of California, Irvine. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-25.

Sponsored by University of California, Irvine · Observational

Why this study was withdrawn
Nonapplicable clinical trial
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Lower Urinary Tract Symptoms
  • Gynecologic Malignancy

Keywords

  • Lower urinary tract symptoms
  • Gynecologic malignancy
  • Urinary incontinence
  • Fecal incontinence
  • Frequency
  • Voiding dysfunction
  • Sexual dysfunction
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

Browse Neoplasms studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Exclusion Criteria:

  • Subjects less than 18 years of age
  • Subjects unable to give informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
06

What researchers measure

Primary outcomes

  1. The outcome will be measured using validated general and condition-specific questionnaires.

    Time frame: 7 months

07

Study locations

1 site
  • University of California, Irvine Medical Center
    Orange, California 92868, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00580697
Lead sponsor
University of California, Irvine
Responsible party
Sponsor
First posted
Dec 27, 2007
Start date
Mar 2006
Primary completion
Mar 2006
Completion
Mar 2006
Last update
Jan 25, 2021

Study contacts

Karen L Noblett, M.D.
principal investigator · University of California, Irvine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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