Polyacrylamide Injection in Patients Ineligible for Surgery

Urinary Incontinence Clinical Trial

Official title:

Transurethral Polyacrylamide Hydrogel Injection in Patients Ineligible for Midurethral Sling Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776423
• Other study ID #: SUGM
• Status: Completed
• Phase: N/A
• First received: May 14, 2016
• Last updated: May 17, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chancellor of Justice Sweden:
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary distress inventory (UDI) overall score		6 months	No
Secondary	UDI stress score		6 months	No
Secondary	UDI irritative score		6 months	No
Secondary	UDI obstructive score		6 months	No
Secondary	Adverse events		6 months	Yes