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
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

September 4, 2012
September 16, 2012
September 2012
January 2014   (final data collection date for primary outcome measure)
Incidence of bladder symptoms [ Time Frame: within 6 months after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01683890 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pattern change of bladder symptoms after surgery [ Time Frame: within 1 month before surgery and within 6 months after surgery ] [ Designated as safety issue: No ]
  • Sexual function change [ Time Frame: within 1 month before surgery 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 ]
Not Provided
Not Provided
 
Study on Bladder and Sexual Function Change After Simple Hysterectomy
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Benign Uterine Disease
Not Provided
Simple hysterectomy group
Patients will undergo simple hysterectomy due to benign uterine disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
January 2014   (final data collection date for primary outcome measure)

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
Female
20 Years to 80 Years
No
Contact: Hee-Dong Chae, M.D., Ph.D. 82-2-3010-3649 hdchae@amc.seoul.kr
Korea, Republic of
 
NCT01683890
SBSFSH
No
Hee-Dong Chae, Asan Medical Center
Asan Medical Center
Astellas Pharma Inc
Principal Investigator: Hee-Dong Chae, M.D., Ph.D. Asan Medical Center
Asan Medical Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP