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

Intrauterine Adhesion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167296
• Other study ID #: SKH-8302-99-DR-27
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2010
• Last updated: June 7, 2013
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2013
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• intrauterine adhesion women

Exclusion Criteria:

• allergic to Cook balloon uterine stent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intrauterine Adhesion

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intrauterine bacteria count		one year	No
Secondary	intrauterine adhesion		one year	No