Developed by Brandhouse A/S, Copenhagen
   

PATIENTPROFESSIONALNEWS & EVENTSABOUT USCONTACT

 
       

Professional

 

Clinical trials

 
 


 

A clinical study which included both severely incontinent patients and patients with multiple previous inconclusive surgery, and with the aim of investigating the efficacy and safety of transurethral injection of Contura’s hydrogel was carried out at the Gynaecological/Obstetric Department at the Glostrup County Hospital, University of Copenhagen, Denmark and at the Urological Department at Aarhus University Hospital Skejby Sygehus, Denmark.

Number of participants - 25
Control visits - 1/3/12 months
Dropouts - 4
Telephone interview - 6 months
Re-injections - 11
 

The hydrogel (1.5 - 2.5 ml) was injected transurethrally in 2-3 deposits under endoscopic control using conventional cystoscopes. If the first injection was not satisfactory, a re-injection was offered to the patients three months after the initial treatment.

All patients were subjected to urodynamic tests before and three months after the treatment.

Efficacy was assessed by Stamey Score, Incontinence Episode Frequency, 48h pad weighting test and The King’s Health Questionnaire. The results of the clinical study showed significant improvements with no adverse reactions.

 
Trial diagram 1
Trial diagram 2