Polyacrylamide Injection in Patients Ineligible for Surgery

NCT02776423 | Completed

• 1 other identifier: SUGM
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Urinary distress inventory (UDI) overall score

  6 months

Secondary Outcomes (4)

• UDI stress score

  6 months

• UDI irritative score

  6 months

• UDI obstructive score

  6 months

• Adverse events

  6 months

Interventions

Bulkamid PROCEDURE

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.

Also known as: Polyacrylamide hydrogel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (1)

• 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.

  PMID: 28106655 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Bulkamid; polyacrylamide gels

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Altman, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 14, 2016
• First Posted: May 18, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share