Polyacrylamide Injection in Patients Ineligible for Surgery

Transurethral Polyacrylamide Hydrogel Injection in Patients Ineligible for Midurethral Sling Surgery

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Procedure: Bulkamid

Detailed 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 Type: Observational
• Enrollment (Actual): 81

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

In this prospective observational study we included 81 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.

Description

Inclusion Criteria:

• Women with stress urinary incontinence considered ineligible for surgery based on significant co-morbidity, one or more previously failed invasive treatments, complex urinary incontinence, or previous pelvic radiation therapy.

Exclusion Criteria:

• Patients who do not want treatment or to participate in study follow-up
• Below 18 years of age

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary distress inventory (UDI) overall score	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	6 months
UDI stress score	6 months
UDI irritative score	6 months
UDI obstructive score	6 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Daniel Altman, MD, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Altman D, Ghilotti F, Bellocco R, Zetterstrom J, Kopp Kallner H. Transurethral Polyacrylamide Hydrogel Injection Therapy in Women Not Eligible for Midurethral Sling Surgery. Female Pelvic Med Reconstr Surg. 2017 Sep/Oct;23(5):318-323. doi: 10.1097/SPV.0000000000000385.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 14, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: SUGM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No