Polyacrylamide Injection in Patients Ineligible for Surgery

Urinary Incontinence Clinical Trial

Official title: Transurethral Polyacrylamide Hydrogel Injection in Patients Ineligible for Midurethral Sling Surgery

Status Completed

Clinical Trial Summary

Transurethral injection using polyacrylamide hydrogel (Bulkamid®, Contura A/S, Denmark) is an established treatment for stress urinary incontinence. The rates of women reporting improvement or cure after Bulkamid injection for stress urinary incontinence range between 64-77% with a very low morbidity. However, the indications for use are unclear. Although transurethral polyacrylamide hydrogel injection is inferior to midurethral slings with regard to expected cure rates, the procedure is associated with very low rates of adverse events in general and serious adverse event in particular. As such, it may be an important alternative for patients where surgery is not considered a safe option either because of co-morbidity or because of complicated incontinence. The investigators performed a prospective study to determine the effects of transurethral polyacrylamide hydrogel injection in patients considered ineligible for midurethral sling surgery.

Clinical Trial Description

In this prospective observational study the investigators included female patients who received treatment with transurethral polyacrylamide hydrogel injection (Bulkamid®). Patients were considered ineligible for surgery based on significant co-morbidity, one or more previously failed invasive treatments, complex urinary incontinence, or previous pelvic radiation therapy. At the baseline visit patients underwent a routine gynecological exam including pelvic ultrasonography. Patients completed validated questionnaires at the baseline visit and follow-up for evaluation of subjective treatment success. At baseline, women were asked to self-report any concomitant diseases or health conditions which were noted in the patient records together with a standard gynecological, urological and general health history. Follow-up visits were scheduled at 2 and 6 months after first injection at which time a second injection was administered at patients' discretion. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Incontinence

• NCT number: NCT02776423
• Study type: Observational
• Source: Karolinska Institutet
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: January 2016