G-BA starts new trial studies

Berlin. The Federal Joint Committee (G-BA) is starting two new trials – on drug-coated balloon dilatation catheters for urethral strictures and on magnetic esophageal sphincter augmentation.

As the G-BA announced on Monday, the bidding consortium Gesundheitsforen Leipzig/Clinische Studien Gesellschaft mbH, an independent scientific institution, will carry out a trial study on behalf of the G-BA. The preceding tendering process has thus been completed. The study is intended to clarify whether treatment with a drug-coated balloon dilatation catheter is superior to the current standard procedure for adult men with recurrent urethral strictures.

In the next few months, the independent scientific institution will prepare the study protocol based on the G-BA testing guidelines and select suitable study centers. After the study has been completed, it will evaluate the data and write a final report. The results should enable the G-BA to make a final assessment of the benefits of the new treatment method. Preparatory work for the study will begin in the next few weeks.

Drug-coated balloon dilatation catheter versus surgical tissue incision

If a man's urethra is narrowed - for example due to scarring after an injury or inflammation - this is referred to as urethral strictures. The strictures can narrow the urethra so much that the affected person has difficulty emptying their bladder. This can lead to urinary tract infections and cause bladder and kidney damage.

The trial study is intended to record the results of the treatment of urethral strictures with a drug-coated balloon dilatation catheter. This is pushed through the urethra to the narrowing, widens it and releases an antiproliferative drug locally. The comparative therapy is the incision made from the inside of the urethra at the narrowing (internal urethrotomy), the standard surgical treatment.

According to the G-BA, the primary endpoints of the trial are clinically relevant improvements in symptoms such as discomfort when urinating (according to the International Prostate Symptoms Score (IPSS)) and the stricture-free rate over 12 months.

The trial study was triggered by a § 137h procedure (evaluation of new examination and treatment methods with high-risk medical devices according to § 137h SGB V).

Comparison of MSA and laparoscopic fundoplication

The second trial study focuses on magnetic esophageal sphincter augmentation (MSA) for gastroesophageal reflux disease. The bidding consortium WIG2 GmbH/GREENBAY research/inspiring health/ZEG was awarded the contract to conduct the study as an independent scientific institution. The preceding tendering process has thus also been completed.

MSA is a surgical treatment method in which a flexible ring-shaped implant is placed around the lower part of the esophagus. The aim is to use the magnetic ring to strengthen the lower part of the esophagus and thus prevent reflux from the stomach. The operation is performed laparoscopically. In the trial study, MSA is compared with the current standard surgical procedure of laparoscopic fundoplication (LF). In LF, a loop is formed from part of the stomach wall, placed like a cuff around the lower part of the esophagus and fixed in place.

The aim of the trial is to investigate whether MSA is not inferior to LF in the endpoint of health-related quality of life in patients with gastroesophageal reflux disease confirmed by pH measurement and whether there is an advantage in returning to normal everyday activities. The trial was triggered by an application from a medical device manufacturer. (eb)