Polyacrylamide Injection in Patients Ineligible for Surgery

CompletedOBSERVATIONAL
Enrollment

81

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

January 31, 2016

Conditions
Urinary Incontinence
Interventions
PROCEDURE

Bulkamid

The procedure was standardized, identical for all patients, and entirely performed in an outpatient setting. All injections were performed by a single urogynecologist. Before injection all patients received a single dose trimethoprim (Idotrim®, Orion Pharma). The patient was placed in a supine position and given intraurethral topical 2% lidocaine hydrochloride gel (Xylocain®, Astra Zeneca) for anesthetic. Using a video-urethroscope and a 23-gauge needle, polyacrylamide hydrogel deposits of 0.3-0.4 mL were injected at 12, 4 and 8 o´clock into the submucosa approximately 1 cm from the bladder neck. Patients were discharged after successful voiding.

All Listed Sponsors
lead

Karolinska Institutet

OTHER

NCT02776423 - Polyacrylamide Injection in Patients Ineligible for Surgery | Biotech Hunter | Biotech Hunter