Efficacy of polyacrylamide hydrogel (Bulkamid®) for the management of urinary stress incontinence in women

Bachkangi P1, Ibrahim S2, Salman M3

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 515
Pelvic Floor Dysfunction 2
Scientific Podium Short Oral Session 34
On-Demand
Female Stress Urinary Incontinence Surgery Quality of Life (QoL)
1. Northern Lincolnshire and Goole NHS Foundation Trust, 2. Bedford Hospital NHS Trust, 3. United Lincolnshire Hospitals NHS Trust
Presenter
P

Panayoti Bachkangi

Links

Abstract

Hypothesis / aims of study
Urinary stress incontinence (USI) is a common condition affecting one third of the female population [1].  There are different conservative and surgical approaches to manage such symptoms. In the recent years different surgical methods have been introduced, aiming successful results with less surgical complications. 

A polyacrylamide hydrogel (Bulkamid®) injection in the urethra is a novel technique that is used for the treatment of USI. It has proven to be a safe method, but with limited research studies examining its efficacy [2]. 

The aim of our study was to examine how effective and safe are the polyacrylamide hydrogel (Bulkamid®) injections in controlling the symptoms of USI.
Study design, materials and methods
A retrospective study, conducted in a busy Trust, examining all the patients who underwent urethral injection with polyacrylamide hydrogel (Bulkamid®). 108 patients had the surgery since its introduction to our Trust in September 2016 and in the following three years. 

The data were obtained from the surgical notes and BSUG (British society of urogynaecology) database.
Results
108 patients underwent polyacrylamide hydrogel (Bulkamid®) urethral injection in the two main hospitals of our trusts over the period of three years. 54 procedures were performed by gynaecologists and 54 by urologists. 

90 patients were having primary procedure. 18 (16%) patients were having a repeat procedure but only 10 (9%) of them had previously Bulkamid injection. 102 (94.4%) procedures were performed by consultants.

The average BMI was 31; with the exception of one patient whose BMI was 57, the rest of the patients ranged between 22.7 and 43. 
The average age was 56 years (31 – 84).  

Complications: There have been no intra-operative complications (0%). 5 patients experienced post-operative complications (4.6%), 3 in the form of urgency, one retention and one developed urinary tract infection.  All five patients were operated by consultants. 

Success of the procedure included both complete cure or improvement of symptoms and it was 78% with similar rates in both gynaecologists and urologists.
Interpretation of results
Our success rates were similar to the rates suggested in other studies (67% and 88%) while our complication rates were notably lower than the rates suggested in literature. Neither age nor BMI had an impact on the success of the procedure or incidence of complications.

In the recent years following the “mesh pause” more invasive procedures emerged again. Surgeries like colposuspension and fascial slings which had become less popular among surgeons and patients became the first options of surgical treatment of USI.  In view of the invasiveness of these surgeries and the potential complications, alternative approaches became prevalent. 

Nevertheless, NICE recommends that urethral bulking agents are to be offered only “if alternative surgical procedures are not suitable for or acceptable” and following a detailed counselling regarding the limited evidence about the procedure, the steps of the surgery and that repeated injections may be necessary [3].  

Admittedly, previous long-term studies suggested disappointing results with collagen urethral injection . This has not been the case with polyacrylamide hydrogel (Bulkamid®) where emerging studies suggest it is a promising and safe procedure.
Concluding message
Polyacrylamide hydrogel (Bulkamid®) urethral injection is a successful alternative surgical procedure for USI. It manages to control the USI symptoms in patients of various ages and BMIs and the technique is easy to learn. Moreover, it is associated with patient satisfaction. On the downside, it is a procedure that might need repeating. 

Still, given the easiness of the surgery, the success rates, the patients’ approval and the ability to perform it as an outpatient procedure, polyacrylamide hydrogel (Bulkamid®) proves to be an effective alternative surgery for USI.
References
  1. Bachkangi, P., & Salman, M. (2019). Complications of Mid-Urethral Tape Insertion. Journal Of Clinical Gynecology And Obstetrics, 8(2), 44-47.
  2. Kasi, A.D., Pergialiotis, V., Perrea, D.N. et al. Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature. Int Urogynecol J 27, 367–375 (2016). https://doi.org/10.1007/s00192-015-2781-y
  3. National Institute for Health and Care Excellence. Urinary incontinence and pelvic organ prolapse in women: management [Internet]. [London]: NICE; April 2019 [updated June 2019] (Clinical guideline [CG123]). Available from: https://www.nice.org.uk/guidance/ng123
Disclosures
Funding No funding or grants were obtained for this study. Clinical Trial No Subjects Human Ethics not Req'd The study was based on a retrospective audit from which the data were obtained. The audit and subsequent analyses got R&D clearance. Helsinki Yes Informed Consent Yes
25/04/2024 07:53:27