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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yu-Hung Lin, Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01167296
First received: July 21, 2010
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Intrauterine Adhesion
Device: Cook balloon uterine stent
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • intrauterine bacteria count [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intrauterine adhesion [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • intrauterine adhesion women

Exclusion Criteria:

  • allergic to Cook balloon uterine stent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01167296

Locations
Taiwan
Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital
Taipei, Taiwan, 111
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
  More Information

No publications provided

Responsible Party: Yu-Hung Lin, MD, Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT01167296     History of Changes
Other Study ID Numbers: SKH-8302-99-DR-27
Study First Received: July 21, 2010
Last Updated: June 7, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Intrauterine adhesion
Cook balloon uterine stent

ClinicalTrials.gov processed this record on September 18, 2014