The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome

Study Overview
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Brief Summary
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Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.

Detailed Description
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The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Official Title
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Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Device: disposable balloon uterine stent
* Device: Foley catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20-40 years; Moderate to severe intrauterine adhesion (AFS score ≥5）; complains of menstruation disorder and reproductive dysfunction Agreement to have second-look hysteroscopy informed consent Exclusion Criteria: ovarian failure patients who did not proceed to second-look hysteroscopy within the specified time frame Contraindication of hormone

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foley catheter<br>After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery. | Device: Foley catheter<br>* Foley catheter can partly separate the sides of uterus wall.<br>|
| Experimental: Disposable balloon uterine stent<br>After the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery. | Device: disposable balloon uterine stent<br>* The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| second diagnostic hysteroscopy | AFS score（The American Fertility Society classifications） | Within the first 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstruation Pattern | Improvement or No Significant Change | Within the first 3 months after surgery | 
| Number of participants with pregnancy | Number of biochemical pregnancies and clinical pregnancies | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asherman syndrome, disposable balloon uterine stent, hysteroscopy, Foley catheter