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

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

Study Overview

• Status: Completed
• Conditions: Intrauterine Adhesion
• Intervention / Treatment: Device: Cook balloon uterine stent

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111
    • Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• intrauterine adhesion women

Exclusion Criteria:

• allergic to Cook balloon uterine stent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Experimental: without 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
intrauterine bacteria count	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
intrauterine adhesion	one year

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Publications and helpful links

General Publications

• Lin YH, Jang TN, Hwang JL, Huang LW, Seow KM, Hsieh BC, Huang CH. Bacterial colonization with balloon uterine stent placement in the uterus for 30 days: a randomized controlled clinical trial. Fertil Steril. 2015 Feb;103(2):513-8.e2. doi: 10.1016/j.fertnstert.2014.10.032. Epub 2014 Nov 20.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 7, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Intrauterine adhesion; Cook balloon uterine stent
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: SKH-8302-99-DR-27