• Female over the age of 18
• History of bladder leaks (SUI) for at least 12 months
• Unsuccessful non-surgical treatment (any one of the following: behavior modification, bladder training exercises, pelvic muscle rehabilitation, biofeedback, electrical or drug therapy)
• Available to attend 11 visits over a period of 36 months
• Antwerp, University Hospital of Antwerp
• Brussels, University Hospital of Brussels
• Ghent, University Hospital of Ghent
• Napoli, Università Degli Studi Di Napoli “Federico II”,Facoltà di Medicina E Chirurgia
• Roma, Universita di Roma “Campus Biomedico”
• Maastricht, MUMC+
• Eindhoven, Catharina Hospital
The Solace Balloon is a novel, non-surgical treatment alternative for unexpected bladder leaks.The Solace Balloon is cleared for sale in Europe, and the purpose of this study is to gather additional information about the Solace Balloon Procedure. If you qualify and choose to join the Solace Study, you will be treated by a trained bladder specialist and will receive all study-related care at no cost. This includes the Solace Balloon Procedure, as well as any examinations or visits required for the study. As a participant in the Solace Study you will visit your study doctor’s office approximately eleven (11) times over thirty-six (36) months to provide feedback about your experiences.
The Solace European Confirmatory Trial (SOLECT TRIAL)
has completed patient enrollment.
Solace Therapeutics will begin enrolling patients in up to 20 clinical sites throughout the USA.
220 women will be eligible to participate in the trial to test the effectiveness of the Solace Bladder Control Balloon.