Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month

Phase 4

Completed

• Conditions: Intrauterine Adhesion
• Interventions: Device: Cook balloon uterine stent

• Registration Number: NCT01167296
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Brief Summary

To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.

Detailed Description

Background：Intrauterine adhesion (IUA) can cause infertility. Hysteroscopic surgery can effectively treat most IUA. In order to prevent adhesion reformation after surgery, most gynecologists will prescribe high-dose estrogen to stimulate endometrial growth, and leave an IUD or a Foley catheter in uterus for 1-3 months. But neither IUD nor Foley catheter conform to the uterine cavity. The Cook balloon uterine stent was designed to fit into the uterine cavity. But it was designed to tamponade the uterus to prevent post-operative uterine bleeding. It's not known if it can be left in the uterus for 30 days.

Study Design：Uterine culture was done before hysteroscopic surgery, and 30 days later. The study group comprise patients with uterine stent; the control group comprise patients who undergo hysteroscopic surgeries but without uterine stent.

Method：Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity. The removed uterine stent was sent for bacterial culture too. The same procedures are done for patients with and without uterine stent. The bacterial counts will be compared before and after hysterosocpic surgeries, and between the two groups of patients.

Effect：If leaving the uterine stent in the uterus up to 30 days does not cause bacteria to grow, we can be confident to leave the stent for 30 days.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-07
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• intrauterine adhesion women

Exclusion Criteria

• allergic to Cook balloon uterine stent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cook balloon uterine stent	Cook balloon uterine stent	Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.removed uterine stent was sent for bacterial culture too.
without Cook balloon uterine stent	Cook balloon uterine stent	Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.

Primary Outcome Measures

Name	Time	Method
intrauterine bacteria count	one year

Secondary Outcome Measures

Name	Time	Method
intrauterine adhesion	one year

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital; 🇨🇳 Taipei, Taiwan