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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167296
First Posted: July 22, 2010
Last Update Posted: June 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yu-Hung Lin, Shin Kong Wu Ho-Su Memorial Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yu-Hung Lin, Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • intrauterine bacteria count [ Time Frame: one year ]

Secondary Outcome Measures:
  • intrauterine adhesion [ Time Frame: one year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: July 21, 2010
First Posted: July 22, 2010
Last Update Posted: June 10, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes