Study on Bladder and Sexual Function Change After Simple Hysterectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Asan Medical Center.
Recruitment status was Recruiting
Astellas Pharma Inc
Information provided by (Responsible Party):
Hee-Dong Chae, Asan Medical Center
First received: September 4, 2012
Last updated: September 16, 2012
Last verified: September 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy
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:
| Study Start Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
Simple hysterectomy group
Patients will undergo simple hysterectomy due to benign uterine disease.
|Ages Eligible for Study:
||20 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patinets who undergo simple hysterectomy due to benign uterine disease at university hospital
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01683890
|Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
|Seoul, Korea, Republic of, 138-736 |
|Contact: Hee-Dong Chae, M.D., Ph.D. 82-2-3010-3649 firstname.lastname@example.org |
Asan Medical Center
Astellas Pharma Inc
||Hee-Dong Chae, M.D., Ph.D.
||Asan Medical Center
No publications provided
||Hee-Dong Chae, Professor, Asan Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 4, 2012
||September 16, 2012
||Korea: Asan Medical Center Institutional Review Board
Keywords provided by Asan Medical Center:
Quality of life
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014
Genital Diseases, Female