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OpenTrials
Completed

NCT Number: NCT02776423

Polyacrylamide Injection in Patients Ineligible for 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Polyacrylamide hydrogel

Primary outcomes

  1. Urinary distress inventory (UDI) overall score

    Time frame: 6 months

Secondary outcomes

  1. UDI stress score

    Time frame: 6 months

  2. UDI irritative score

    Time frame: 6 months

  3. UDI obstructive score

    Time frame: 6 months

  4. Adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Transurethral Polyacrylamide Hydrogel Injection in Patients Ineligible for Midurethral Sling Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 18, 2016
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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