Study on Bladder and Sexual Function Change After Simple Hysterectomy

• Conditions: Benign Uterine Disease

• Registration Number: NCT01683890
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-08
• Study First Posted: 2012-09-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of bladder symptoms	within 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Sexual function change	Baseline and within 6 months after surgery
Quality of life	within 6 months aftr surgery
Pattern change of bladder symptoms after surgery	Baseline and within 6 months after surgery

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of