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Study on Bladder and Sexual Function Change After Simple Hysterectomy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683890
First Posted: September 12, 2012
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Hee-Dong Chae, Asan Medical Center
  Purpose
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.

Condition
Benign Uterine Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy

Resource links provided by NLM:


Further study details as provided by Hee-Dong Chae, Asan Medical Center:

Primary Outcome Measures:
  • Incidence of bladder symptoms [ Time Frame: within 6 months after surgery ]

Secondary Outcome Measures:
  • Pattern change of bladder symptoms after surgery [ Time Frame: Baseline and within 6 months after surgery ]
  • Sexual function change [ Time Frame: Baseline and within 6 months after surgery ]
  • Quality of life [ Time Frame: within 6 months aftr surgery ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Simple hysterectomy group
Patients will undergo simple hysterectomy due to benign uterine disease.

  Eligibility

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patinets who undergo simple hysterectomy due to benign uterine disease at university hospital
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683890


Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Astellas Pharma Inc
Investigators
Principal Investigator: Hee-Dong Chae, M.D., Ph.D. Asan Medical Center
  More Information

Responsible Party: Hee-Dong Chae, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01683890     History of Changes
Other Study ID Numbers: SBSFSH
First Submitted: September 4, 2012
First Posted: September 12, 2012
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Hee-Dong Chae, Asan Medical Center:
Bladder symptoms
Sexual function
Quality of life
Simple hysterectomy

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female