NCT00580697

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

December 19, 2007

Last Update Submit

January 22, 2021

Conditions

Lower Urinary Tract SymptomsGynecologic Malignancy

Keywords

Lower urinary tract symptomsGynecologic malignancyUrinary incontinenceFecal incontinenceFrequencyVoiding dysfunctionSexual dysfunction

Outcome Measures

Primary Outcomes (1)

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

    7 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Subjects with a new diagnosis of gynecologic malignancy who plan to undergo surgical management, including cervical, endometrial, and ovarian cancer.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrinary IncontinenceFecal IncontinenceSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGenital Diseases

Study Officials

  • Karen L Noblett, M.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 27, 2007

Study Start

March 1, 2006

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

US(1)