Use of polyacrylamide hydrogel peri-urethral injection in women with stress urinary incontinence at the time of surgical management for pelvic organ prolapse in comparison to peri-urethral injection alone: A pilot study.

Lemmon B1, Kohler-Boureq C1, Cardozo L2, Bray R1, Cortes E1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 789
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Stress Urinary Incontinence Pelvic Organ Prolapse Female
1.Kingston Hospital, 2.King's College Hospital
Links

Abstract

Hypothesis / aims of study
Polyacrylamide hydrogel periurethral injection is used as one of the many injectable agents available to manage stress urinary incontinence [1]. Bulking agents are a minimally invasive low risk alternative to synthetic slings. Raised awareness of complications associated with mesh procedures and the recent controversy in the UK regarding the use of synthetic material has led to patients attending our urogynaecology unit seeking an alternative to their planned transvaginal tape. In this pilot study we have looked at the use of peri-urethral bulking agents used at the same time as pelvic organ prolapse surgery to manage stress urinary incontinence.
Study design, materials and methods
ICIQ-FLUTS and ICIQ-VS questionnaires (PRO-patient reported outcomes) were completed by women having urogynaecological procedures as part of routine entry into the British Society of Urogynaecology (BSUG) database. We compared the symptom scores of 10 women having isolated peri-urethral injection with polyacrylamide hydrogel with 7 women having prolapse repair and peri-urethral bulking injection in a one-step procedure. All patients had between 1.5 – 2ml of polyacrylamide agent injected peri-urethrally as per the manufacturer’s protocol. Patients receiving peri-urethral injection alone were assessed pre-procedure and all scored 0 for the ICIQ-VS indicating that did not have pelvic organ prolapse. Patients having concurrent prolapse repair had a variety of pelvic floor prolapse procedures (vaginal hysterectomy, anterior and posterior prolapse repair). They all had a postoperative vaginal pack and size 12 urinary catheter inserted overnight and removed the following morning.
Results
All 10 patients receiving peri-urethral bulking had their procedures performed as a day-case. The 7 patients who underwent prolapse repair with bulking injection together were all discharged home the morning after their procedure. There were no intra-operative complications in either group. One patient experienced urinary retention post-operatively but passed “trial without catheter” 48hours later. 
Results of the ICIQ-FLUTS questionnaires demonstrated improvement in symptoms scores for both groups. In the peri-urethral injection only group, 3 out of 10 patients did not show improvement in their scores and they have subsequently been offered repeat injection procedures. For the remaining 7 patients there was mean percentage improvement of 52.7% in their symptom scores. In the prolapse repair with peri-urethral bulking group, 1 of the 7 patients did not have improvement in their ICIQ-FLUTs scores. Of the 6 patients that did show symptoms improvement the mean percentage change was 51.6%. There was no significant difference in voiding scores pre and post-op for either group.  There was significant improvement in both groups in incontinence and filling scores pre and post operatively. A Mann Whitney Test including the patients with no improvement showed no statistical difference between the improvement scores achieved in the two groups.
Interpretation of results
It remains a subject of debate whether prolapse repair and peri-urethral injection should be performed as a one-step procedure. Prolapse repair routinely involves insertion of a vaginal pack and placing an indwelling catheter post-operatively for between 24-48 hours. The argument against performing concomitant surgery is that by placing an indwelling catheter, there is a risk of causing local redistribution of the polyacrylamide hydrogel and therefore reducing it's effect to reduce stress urinary incontinence. Our preliminary results show that the use of peri-urethral agents at the time of prolapse surgery is not detrimental to continence outcomes and that the improvement in symptoms for these 2 groups is similar. The results seen using ICIQ-FLUTS and ICIQ-VS as validated questionnaires post-operatively is in line with previous studies looking at patient reported outcomes (PRO) following peri-urethral injections [2,3].
Concluding message
Our pilot study is the first study to examine the use of concomitant bulking agents at the time of prolapse surgery. Our results show equivalence in continence outcomes when bulking is used at the time of prolapse surgery using patient reported outcomes.  Larger studies are needed to confirm these preliminary findings and duration of symptom improvement.
Figure 1 Bar chart showing change in total score. before and after procedures in the peri-urethral bulking group and peri-urethral bulking with prolapse surgery group
Figure 2 Table of total F, V and I scores and total F+V+I scores for the with and without prolapse groups from ICIQ-FLUTS questionnaires
References
  1. Kasi AD, Pergialiotis V, Perrea DN, Khunda A, Doumouchtsis SK Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review on the literature. In Urogynaecol J 27:367-375 (2016)
  2. Toozs-Hobson P, Al-Singary W, Fynes M, Tegerstedt G, Lose G Two-year follow-up of an open-label multicentre study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence, Int Urogynaecol J 23:1373-1378 (2012)
  3. Lose G, Sorensen HC, Axelsen SM, Falconer C, Lobodasch K, Safwat T An open multicentre study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence, Int Urogynaecol 21:1471–1477 (2010)
Disclosures
<span class="text-strong">Funding</span> No funding or grant given for this pilot study <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics not Req'd</span> This was analysis of questionaires filled out as a routine by every patient undergoing a urogynaecological procedure for the British Society of Urogynaecologists Database <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes