Study on Bladder and Sexual Function Change After Simple Hysterectomy

NCT ID: NCT01683890

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Uterine Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Simple hysterectomy group

Patients will undergo simple hysterectomy due to benign uterine disease.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hee-Dong Chae

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Dong Chae, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SBSFSH

Identifier Type: -

Identifier Source: org_study_id

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