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Study on Bladder and Sexual Function Change After Simple Hysterectomy

This study is currently recruiting participants.
Verified September 2012 by Asan Medical Center
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Hee-Dong Chae, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01683890
First received: September 4, 2012
Last updated: September 16, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Incidence of bladder symptoms [ Time Frame: within 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pattern change of bladder symptoms after surgery [ Time Frame: Baseline and within 6 months after surgery ] [ Designated as safety issue: No ]
  • Sexual function change [ Time Frame: Baseline and within 6 months after surgery ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: within 6 months aftr surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Simple hysterectomy group
Patients will undergo simple hysterectomy due to benign uterine disease.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683890

Contacts
Contact: Hee-Dong Chae, M.D., Ph.D. 82-2-3010-3649 hdchae@amc.seoul.kr

Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Hee-Dong Chae, M.D., Ph.D.     82-2-3010-3649     hdchae@amc.seoul.kr    
Sponsors and Collaborators
Asan Medical Center
Astellas Pharma Inc
Investigators
Principal Investigator: Hee-Dong Chae, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Hee-Dong Chae, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01683890     History of Changes
Other Study ID Numbers: SBSFSH
Study First Received: September 4, 2012
Last Updated: September 16, 2012
Health Authority: Korea: Asan Medical Center Institutional Review Board

Keywords provided by Asan Medical Center:
Bladder symptoms
Sexual function
Quality of life
Simple hysterectomy

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013