Randomized controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis

Capsule:
The insertion of an intrauterine balloon and an intrauterine device are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis in Asherman syndrome.

Authors:
Xiao-Na Lin, M.Sc., Feng Zhou, M.Med., Min-Ling Wei, M.Med., Yang Yang, M.Med., Ying Li, M.B., B.S., T.C. Li, M.D., Ph.D., Song-Ying Zhang, M.D., Ph.D.

Volume 104, Issue 1, Pages 235-240

Authors:

Objective:
To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device (IUD) in the prevention of adhesion reformation after hysteroscopic adhesiolysis.

Design:
Prospective, randomized, controlled trial.

Setting:
University hospital.

Patient(s):
A total of 201 women with Asherman syndrome.

Intervention(s):
Women were randomised to having either a heart-shaped intrauterine balloon or an IUD fitted after hysteroscopic adhesiolysis. The devices were removed after 7 days. A second-look hysteroscopy was carried out 1 to 2 months after the surgery.

Main Outcome Measure(s):
Incidence of adhesion reformation and reduction of adhesion score before and after surgery.

Result(s):
Initially 201 cases were recruited; 39 cases dropped out, resulting in 82 cases in the balloon group and 80 cases in IUD group. The age, menstrual characteristics, pregnancy history, and American Fertility Society score before surgery were comparable between the two groups. The median adhesion score reduction (balloon group, 7; IUD group, 7) and the adhesion reformation rate (balloon group, 30%; IUD group, 35%) were not significantly different between the two groups.

Conclusion(s):
The heart-shaped intrauterine balloon and IUD are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome.

Clinical Trial Registration Number:
ISRCTN 69690272.

  • Amanda N. Kallen

    Thanks to the authors for a very interesting study. While I agree with the authors that it would also have been nice to see a control group, it’s also true as they state that prior studies suggest benefit of the balloon or IUD. In my practice, we typically use the balloon for adhesion prevention – could the authors comment on cost difference between the balloon and heart-shaped IUD in their area of practice?

    • SongYing Zhang

      Thanks for the comment. The balloon costs $90 whereas IUD only costs $3 in China, so IUD seems higher cost-performance than balloon. On the other hand, both balloon and IUD are adjuvant therapy, could we think the second look hysteroscopy be more important in preventing re-adhesion?

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