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

Beijing Obstetrics and Gynecology Hospital

Status: Unknown

Conditions: Intrauterine Adhesion

Treatments: Device: disposable balloon uterine stent; Device: Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03330873

No.3-20140601

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Foley catheter

Experimental group

Description:

After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.

Treatment:

Device: Foley catheter

Disposable balloon uterine stent

Experimental group

Description:

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.

Treatment:

Device: disposable balloon uterine stent