Study on Bladder and Sexual Function Change After Simple Hysterectomy

Benign Uterine Disease Clinical Trial

Official title:

Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01683890
• Other study ID #: SBSFSH
• Status: Active, not recruiting
• Phase: N/A
• First received: September 4, 2012
• Last updated: May 27, 2017
• Start date: September 2012
• Est. completion date: July 2017

Study information

• Verified date: May 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Uterine Disease
• Uterine Diseases

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Astellas Pharma Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bladder symptoms		within 6 months after surgery
Secondary	Pattern change of bladder symptoms after surgery		Baseline and within 6 months after surgery
Secondary	Sexual function change		Baseline and within 6 months after surgery
Secondary	Quality of life		within 6 months aftr surgery