Treatment of Mild to Moderate Stress Urinary Incontinence with a Novel Polycaprolactone-Based Bioresorbable Urethral Bulking Agent

Koldewijn E1, Oerlemans D2, Beulens A1, De Wildt M1, Vandoninck V2, De Wachter S3

Research Type


Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 276
Female Stress Urinary Incontinence
Scientific Podium Short Oral Session 19
Friday 9th September 2022
11:52 - 12:00
Hall D
Incontinence Female New Devices Stress Urinary Incontinence
1. Catharina Hospital, Department of Urology, Eindhoven, The Netherlands, 2. Laurentius Hospital, Department of Urology, Roermond, The Netherlands, 3. Antwerp University Hospital, Department of Urology, Edegem, Belgium; Antwerp University, Antwerp Surgical Training, Anatomy and Research Centre (ASTARC), Faculty of Medicine and Health Sciences, Wilrijk, Belgium

Evert Koldewijn



Hypothesis / aims of study
There is a wide range of treatment options available for Stress Urinary Incontinence (SUI), including non-surgical therapy (pelvic floor muscle training, electric stimulation, change in fluid intake and drug therapy) and surgical treatment. The most widely used surgical treatment for SUI is the midurethral sling (MUS) procedure; the retropubic (TVT) or the trans obturator sling (TOT). 
With the recent safety concerns and suggested underestimation of complications such as urethral obstruction requiring surgery, vaginal, bladder and/or urethral erosion requiring surgery, and refractory chronic pain associated with MUS procedures, there is a growing interest for alternative less invasive treatment options for SUI without major risks for complications. One of such alternative minimally invasive treatment option for SUI is the urethral injection of a bulking agent. A fully bioresorbable polycaprolactone-based bioresorbable bulking agent was evaluated for safety and efficacy in female patients with mild to moderate stress urinary incontinence who attempted and failed prior pelvic floor muscle training.
Study design, materials and methods
In this multicenter study, female subjects of 18 years and older were eligible for inclusion. Inclusion criteria consisted of subjects who suffer from predominantly SUI as determined by the Questionnaire for Urinary Incontinence Diagnosis (QUID); Total Stress Score (Sum Q1-3) of ≥ 4 and Total Urge Score (Sum Q4-6) of < 6. Subjects must have attempted or failed prior pelvic floor exercises while incontinent, suffer from mild to moderate SUI as confirmed by the Stamey Grading Scale (SGS) 1 or 2, able to comply with trial follow-up procedures, schedule, and are willing to provide written informed consent for their participation in the trial. Fifty female subjects were treated by transurethral sub-mucosal injection. Over a period of 24 months safety was evaluated during a 24-monts follow-up period. At the 12-month visit, a cystoscopy was performed for visual inspection of the injected area. Efficacy was assessed with the same intervals with the Stamey Grading System (SGS) among others.
Only 6/50 subjects reported transient mild adverse events. The results show for the SGS grade more than 55% of the participants had an improvement in SGS grade of whom 40% were cured within the first 12 months after treatment. During the second year of follow-up the effect seems to falter with an improvement of 50% of the subjects of whom 25% were cured.
Interpretation of results
The aim of the study was to evaluate treatment safety and efficacy of a novel PCL-based bioresorbable bulking agent used for the treatment of mild to moderate SUI in female subjects. In this study the two-year follow-up results are presented. The results of the study suggest that treatment of mild-to-moderate SUI with a bioresorbable PCL-based bulking agent is a safe and effective alternative to permanent bulking agents and intermediate treatment option before the use of the permanent MUS.
Concluding message
A polycaprolactone-based bioresorbable bulking agent was evaluated as a new minimally-invasive treatment option for adult females with mild- to moderate SUI.
Funding This study was sponsored by AQLANE Medical BV, The Netherlands and was performed in collaboration with the Clinical Research Organization Medpace (Maastricht, The Netherlands). Clinical Trial Yes Registration Number Trial Registration: Reference NL5760 (NTR6002) (Netherlands); Reference 80M0633 (Belgium). RCT No Subjects Human Ethics Committee Ethical Committee approval was obtained in The Netherlands and Belgium. Helsinki Yes Informed Consent Yes

Continence 2S2 (2022) 100342
DOI: 10.1016/j.cont.2022.100342

14/06/2024 20:22:57