Clinical trial NCT02776423: Polyacrylamide Injection in Patients Ineligible for Surgery
Official title: Transurethral Polyacrylamide Hydrogel Injection in Patients Ineligible for Midurethral Sling Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary distress inventory (UDI) overall score
timeFrame: 6 months
Secondary outcomes:
measure: UDI stress score
timeFrame: 6 months
measure: UDI irritative score
timeFrame: 6 months
measure: UDI obstructive score
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Daniel Altman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.