Study on Bladder and Sexual Function Change After Simple Hysterectomy

May 27, 2017 updated by: Hee-Dong Chae, Asan Medical Center

Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy

To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring after simple hysterectomy and to analyze the influence of bladder symptoms and sexual function change on quality of life of patients.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patinets who undergo simple hysterectomy due to benign uterine disease at university hospital

Description

Inclusion Criteria:

  • Patients who is planed to undergo simple hysterectomy due to benign uterine disease

    1. Uterine leiomyoma
    2. Uterine adenomyosis
    3. Endometrial hyperplasia
    4. Cervical intraepithelial neoplasia (including carcinoma in situ, FIGO stage IA1 cancer)
    5. Dysfunctional uterine bleeding
    6. Other benign uterine disease requiring hysterectomy

Exclusion Criteria:

  • Patients who are taking medication for overactive bladder
  • Patients who underwent incontinence surgery due to urinary incontinence
  • Acute or chronic infectious disease of urinary tract
  • Neurologic disease causing urinary abnormality
  • Previous pelvic radiation therapy
  • Patients who are undergoing incontinence surgery with hysterectomy
  • Pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Simple hysterectomy group
Patients will undergo simple hysterectomy due to benign uterine disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of bladder symptoms
Time Frame: within 6 months after surgery
within 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pattern change of bladder symptoms after surgery
Time Frame: Baseline and within 6 months after surgery
Baseline and within 6 months after surgery
Sexual function change
Time Frame: Baseline and within 6 months after surgery
Baseline and within 6 months after surgery
Quality of life
Time Frame: within 6 months aftr surgery
within 6 months aftr surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Hee-Dong Chae, M.D., Ph.D., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 8, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBSFSH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Uterine Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe