Accepted Article
1 2 3
Long-term efficacy of polydimethylsiloxane (Macroplastique®) injection for Mitrofanoff leakage after continent urinary diversion surgery1
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A Kass-Ilya1, TG Rashid1, I Citron1, C Foley2, R Hamid1,TJ Greenwell1, PJR Shah1, JL Ockrim1
6
1University
7
2Lister
8
Corresponding author: Jeremy L Ockrim, [email protected]
College London Hospital, 235 Euston Road, London, NW1 2BU
Hospital, Coreys Mill Lane, Stevenage, Hertfordshire, SG1 4AB
9 10 11 12 13 14 15 16 17 18
Corresponding Address:
19
Abstract
20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
To assess the long-term efficacy of polydimethylsiloxane (Macroplastique®) injection (MPI) in the treatment of Mitrofanoff leakage secondary to valve incompetence.
Department of Urology University College London Hospital Ground Floor Central 250 Euston Road London NW1 2PG Telephone: 0203 447 7080 Fax: 0203 447 9303
Patients and methods Between 1995 and 2012, the records of 24 consecutive patients who underwent MPI for Mitrofanoff urinary leakage after continent cutaneous urinary diversion (CCUD) surgery were examined. All patients had a valve deemed of sufficient length (>2cm) to attempt Macroplastique® coaptation. Treatment outcomes were divided into three categories based on physician assessment: success (dry), partial success (>50% reduction in incontinence pads) and failure. Success rates were assessed according to the type of reservoir and conduit channel. Results
Mean follow-up was 30 months (range 6-96). 1 patient had initial difficulty catheterising, and subsequently required major revision surgery. 12 patients (50%) failed the treatment and subsequently underwent operative revision to the channel. 3 patients (12.5%) achieved complete success; 1 patient had an appendix channel through native bladder and the remaining 2 had Monti channels This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/bju.12817
This article is protected by copyright. All rights reserved.
1
through colon. 9 patients (37.5%) had partial success; success rates were higher with appendix channels (4/6) (67%) and colonic reservoirs (6/7) (86%) when compared with Monti channels (8/18) (44%) and ileal reservoirs (0/2) (0%). 5/9 patients with partial success eventually required further surgical revision for deteriorating continence at a mean of 41 months (range 14-96) whilst the other 4 have maintained sufficient continence with MPI alone.
Accepted Article
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Conclusion Macroplastique® bulking cured only 12.5% patients, but leakage was substantially improved in a further 37.5% allowing major surgery to be avoided or postponed in one half of the cohort. Appendix Mitrofanoffs do better than the Monti Mitrofanoff, with channels through colonic segments generally doing better than those through ileal bladders. MPI should be considered as a less invasive alternative to avoid or delay major reconstructive surgery.
16 17
Introduction
18 19 20 21 22 23 24 25 26 27 28
The continent cutaneous urinary diversion (CCUD) is an integral part of the reconstructive surgeon’s armamentarium. Introduced in 1976 by paediatric surgeon Paul Mitrofanoff (1), the technique involves the use of the appendix as a catheterisable conduit between the skin and the native or reconstructed bladder. Subsequently adaptations have been plentiful: popular variations include the Yang-Monti technique, the double-Monti tube and the spiral Monti all of which employ an ileal tube (2,3). As originally described, the Mitrofanoff was utilised in children with congenital or neuropathic bladder dysfunction. As a result, the majority of our outcome data arises from the paediatric population. It has gained popularity for use in specialist units in the adult population following cystourethrectomy for urothelial cancer, neuropathic bladder dysfunction, complex incontinence and pain syndromes.
29 30 31 32 33 34
The CCUD is a highly specialised intervention with a significant rate of complication and surgical revision. Mitrofanoff complications include: problems with catheterisation, stomal stenosis (0-57%) and incontinence (0-50%) (4-6). Revisions of the channel, either at the skin level or requiring laparotomy, have been reported in up to 75.2% (7). Incontinence due to valve incompetence commonly requires open revision of the channel.
35 36 37 38 39 40 41 42
Injection of bulking agents into the native urethra is a recognized treatment modality for (female) stress incontinence. It acts by creating sub-mucosal cushions that improve urethral coaptation (8). Bulking agent injection has a reported short-term success rate of 75% with complete continence in 43% of patients (9). The use of bulking agents to successfully coapt the Mitrofanoff valve is often anecdotally mentioned, but is little reported in the medical literature (10-14). We assess the efficacy of polydimethylsiloxane (Macroplastique®) injection (MPI) in the treatment of Mitrofanoff leakage secondary to valve incompetence.
43 44
This article is protected by copyright. All rights reserved.
2
Accepted Article
1 2
Patients and Methods
3 4 5 6 7 8
We retrospectively evaluated the records of 24 consecutive patients who underwent MPI for urinary leakage following CCUD between 1995 and 2012. All patients had clinically apparent Mitrofanoff leakage, confirmatory pad testing, and videourodynamics to exclude significant other causes (detrusor / neobladder overactivity or poor compliance) for their incontinence. All patients had a valve deemed of sufficient cystoscopic length (>2cm) to attempt Macroplastique® coaptation.
9 10 11 12 13 14 15 16 17
MPI injections were performed by two reconstructive surgeons (PJRS and JLO) with expertise in Mitrofanoff management. The Mitrofanoff channel was visualised through an 11.5F paediatric or 17F Miller cystoscope, using both antegrade stomal, and retrograde urethral approaches where possible. MPI injections were performed using antegrade access using a 5F William needle through the channel. Submucosal cushions were placed at the reservoir-conduit junction and along the conduit as described by Guys et al (11), with injected volumes ranging between 2.5-5 millilitres, until satisfactory visual coaptation was achieved. All patients had post-procedural (urethral or 8-10F Mitrofanoff) catheter drainage for 24 hours.
18 19 20 21 22 23 24 25 26 27
Patients were interviewed in an outpatient setting post-operatively at 6 weeks and 3 months. The number of pads used during 24 hours and the frequency of leakage between catheterization was used to assess incontinence. Treatment outcomes were divided into three categories based on physician assessment: success, partial success and failure. Treatment was considered a success if patients were dry between catheterization and did not use any pads during 24 hours; partial success was defined as a >50% improvement in the frequency of leakage between catheterization or 50% reduction in the number of daily pads used. Failure was assigned if these criteria were not reached. Success rates were assessed according to the type of reservoir and conduit channel.
28 29
The follow-up period was defined as the date of the MPI until the last recorded visit or until the date of any major interventional surgery if earlier.
30 31 32 33 34 35
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3
Results
3 4 5 6 7
Twenty-four patients (21 female; 3 male) underwent endoscopic MPI with mean followup of 30 months (range 6-96). 23/24 patients were discharged within 24 hours. 1 patient had a protracted stay due to difficulty catheterising the CCUD, and subsequently required major revision surgery of the stoma. There were no other (infection, pain, bleeding) associated complications of MPI injection.
8 9 10 11 12 13 14
Original indications for CCUD were: neuropathic bladder (9), atonic bladder (6), complex incontinence (4), cystourethrectomy for urothelial cancer (2), idiopathic detrusor overactivity (2) and bladder pain (1). 6/24 patients had a CCUD tunnelled into a native bladder and 9/24 had the Mitrofanoff channel tunnelled through the bladder segment of an augmented ileo or colonic cystoplasty. 9/24 had the channel tunnelled into the colonic or ileal segment of a neobladder. The type of channel used was appendix in 6 cases, Monti ileal tube in 9 cases, double-Monti ileal tube in 9 cases.
15 16 17 18 19 20 21 22 23 24
Demographics and outcomes are summarised in Table 1 and Figure 1. 3/24 (12.5%) patients achieved complete success (continence) after MPI at a mean follow-up of 66 months (range 32-96). 9/24 (37.5%) reported partial success. The remaining 12/24 patients (50%) did not respond to the treatment. Of the 3 patients who reported complete success, 1 had an appendix channel tunnelled to native bladder and the remaining 2 had Monti channels tunnelled to colon. Of those 9/24 who reported partial success, continence was more likely with appendix channels (4/6, 66%) and colonic reservoirs (6/7, 86%) when compared with Monti channels (8/18, 44%) and ileal tunnels (0/2, 0%) (Figure 1). The diameter of channel access (11.5 versus 17F), nor post operative Mitrofanoff (rather than urethral catheterisation) did not affect outcome.
Accepted Article
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25 26 27 28 29 30 31
Long-term outcomes are shown on Table 2. All 3 patients who had complete success remain dry. Of the nine patients who had partial success, one continues with the single injection, whereas 3 patients needed a second MPI at a mean time interval of 46 months and one patient underwent a third MPI at 96 months to maintain effectiveness. 5/9 patients with partial success eventually required surgical intervention at a mean followup of 34 months (range 14-96).
32 33 34 35 36
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4
Discussion
3 4 5 6 7 8 9
Mitrofanoff incontience is a major complication of reconstructive bladder surgery. The reported rate ranges from 16-61% (3, 15, 16). The psychosocial impact of Mitrofanoff continence should not be underestimated. Successful CCUD continence can restore quality of life to levels comparable to those of the general population (17). Chabchoud et al (18) evaluated 57 patients with Mitrofanoff channels and found that a successful channel enabled 94% of patients to return to work, 79% to return to schooling (where relevant) and 83% to continue a satisfactory sex life.
10 11 12 13 14 15 16 17 18
Incontinence in a CCUD may be due to the bladder or the channel. If related to the bladder, it may be secondary to detrusor overactivity, poor compliance or a reduced capacity. Marshall and Bissada studied the ‘appendiceal leak pressure’ in cadaveric ileocecal pouches. Appendiceal leak occurred at a mean pressure of 50.6cmH20 (range 21-86cmH20) (19). Santucci et al found that CCUDs using a reservoir constructed from right colon with or without ileum provided the best continence whereas stomach and sigmoid had the worst continence rates attributed to decreased capacity, decreased compliance, and a tendency toward high pressure spikes despite detubularization in these tissue types (20).
19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
Mitrofanoff valve incompetence requires major channel revision surgery or stoma diversion. Injection of bulking agents is the only minimally invasive alternative available. Although anecdotally effective, only five previous papers constituting a total of 30 patients, and with mean follow-up of one year have been published (10-14). The first description by Kaefer et al (10) in 1997 describes successful collagen bulking in one child. Guys el al (11) presented a detailed description of the technique of MPI (similar to ours) for the treatment of incontinent urinary diversion in six patients with neuropathic bladder who had undergone bladder augmentation with four appendix and two Monti Mitrofanoff, and reported success rate of 66.7% complete continence at 11 months. Halachmi et al (12) reported the use of MPI injections in 5 paediatric patients with Mitrofanoff (3 patients Monti; 2 patients appendix) to ileal-augmented native or ileal neobladders. Complete continence was achieved in 3 patients and improvement in 1 patient at 9.2 months (range 2-13). Prieto et al (13) reported one or two injections of Dextranomer Hyaluronic Acid (DHA) in 14 paediatric/adult patients with (12 patients appendix; 2 Monti) channels with a dry rate of 79% at 12 months (range 2-36). In 2008, Welk et al (14) reported the injection of DHA in 4 patients with a success rate of 50%. No clear definition of success or follow-up was provided in the study. Success occurred with the 2 appendix channels and failed in the Monti cases.
37 38 39 40 41 42 43 44
To our knowledge this is the largest series and only study with long-term follow-up on the outcome of MPI in patients with CCUD, and is the first to reconcile treatment outcomes with the underlying aetiology, the reservoir type and the conduit channel type. Although we failed to demonstrate any statistically significant trends, our data suggests that appendix Mitrofanoff channels and colonic reservoirs are likely to mount a better treatment response compared to small bowel Monti conduits and reservoirs, this finding could probably be attributed to the histological characteristics (bowel wall thickness) of the appendix and large bowel compared to the small bowel with the
Accepted Article
1 2
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former having a markedly thicker walls (3-4 mm) versus (1-2 mm). This could potentially improve both the coaptation and the cushioning effect of the bulking agent.
3 4 5 6
Whilst MPI injection only cured 12.5% of patients, 50% of patients responded sufficiently to defer major surgery. With 3 years follow-up, the rate of major interventions after MPI was half (5/12 patients versus 12/12 patients) after a successful treatment, with potential advantages for patient’s quality of life.
Accepted Article
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10 11 12
Conclusions
13 14 15 16 17 18 19
Macroplastique bulking cured only 12.5% patients, but leakage was substantially improved in a further 37.5% allowing major surgery to be deferred in half of the cohort. Appendix Mitrofanoff (67%) may do better than Monti Mitrofanoff (44%); with channels through colonic segments (80%) generally doing better than those through native or ileal bladders (43%). MPI is a simple, minimally invasive procedure which should be considered as an alternative to avoid or delay major reconstructive surgery in Mitrofanoff leakage secondary to valve incompetence.
20
Conflicts of Interest
21
None disclosed.
22
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Accepted Article
1 2
References
3 4
1. Mitrofanoff P. Trans-appendicular continent cystostomy in the management of the neurogenic bladder. Chir Pediatr. 1980;21(4):297–305.
5 6
2. Farrugia M, Malone P. Educational article: The Mitrofanoff procedure. J Pediatr Urol. 2010;6(4):330–337.
7 8
3. Woodhouse C, MacNeily A. The Mitrofanoff principle: expanding upon a versatile technique. Br J Urol. 1994;74(4):447–53.
9 10 11
4. Hautmann R, Volkmer B, Schumacher M, Gschwend J, Studer U. Long-term results of standard procedures in urology: the ileal neobladder. World J Urol. 2006;24(3):305–14.
12 13 14 15
5. Wiesner C, Stein R, Pahernik S, Hahn K, Melchior S, Thuroff J. Long-term followup of the intussuscepted ileal nipple and the in situ, submucosally embedded appendix as continence mechanisms of continent urinary diversion with the cutaneous ileocecal pouch (Mainz pouch I). J Urol. 2006;176(1):155–9; dicsussion 159–60.
16 17 18 19
6. Sahadevan K, Pickard RS, Neal DE, Hasan TS. Is continent diversion using the Mitrofanoff principle a viable long-term option for adults requiring bladder replacement? BJU Int [Internet]. 2008 Jul [cited 2013 Dec 21];102(2):236–40. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18279448
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7. Veeratterpillay R, Morton H, Thorpe A, Harding C. Reconstructing the lower urinary tract: The Mitrofanoff principle. Indian J Urol. 2013;29(4):316–321.
22 23 24
8. Pickard R, Reaper J, Wyness L, Cody DJ, McClinton S, N'Dow J. Periurethral injection therapy for urinary incontinence in women. The Cochrane database of systematic reviews. 2003(2):CD003881. Epub 2003/06/14.
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9. Ghoniem GM, Miller CJ. A systematic review and meta-analysis of Macroplastique for treating female stress urinary incontinence. International urogynecology journal. 2013;24(1):27-36. Epub 2012/06/16.
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10. Kaefer M, Tobin MS, Hendren WH, Bauer SB, Peters CA, Atala A, Colodny AH, Mandell J, Retik AB. Continent urinary diversion: the Children's Hospital experience. J Urol. 1997 Apr;157(4):1394-9.
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11. Guys JM, Fakhro A, Haddad M, Louis-Borrione C, Delarue A. Endoscopic cure of stomal leaks in continent diversion. BJU international. 2002;89(6):628-9. Epub 2002/04/12.
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12. Halachmi S, Farhat W, Metcalfe P, Bagli DJ, McLorie GA, Khoury AE. Efficacy of polydimethylsiloxane injection to the bladder neck and leaking diverting stoma for urinary continence. The Journal of urology. 2004;171(3):1287-90. Epub 2004/02/10.
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13. Prieto JC, Perez-Brayfield M, Kirsch AJ, Koyle MA. The treatment of catheterizable stomal incontinence with endoscopic implantation of dextranomer/hyaluronic acid. The Journal of urology. 2006;175(2):709-11. Epub 2006/01/13.
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14. Welk BK, Afshar K, Rapoport D, MacNeily AE. Complications of the Catheterizable Channel Following Continent Urinary Diversion: Their Nature and Timing. J Urol. 2008;180(4):1856–1860.
8 9
15. Harris C, Cooper C, Hutcheson J, Snyder H 3rd. Appendicovesicostomy: the mitrofanoff procedure-a 15-year perspective. J Urol. 2000;163(6):1922–6.
Accepted Article
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16. McAndrew HF, Malone PSJ. Continent catheterizable conduits: which stoma, which conduit and which reservoir? BJU Int [Internet]. 2002 Jan;89(1):86–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11849168
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17. Smith G, Carroll D, Mukherjee S, Aldridge R, Jayakumar S, McCarthy L, et al. Health-related quality of life in patients reliant upon mitrofanoff catheterisation. Eur J Paediatr Surg. 2011;21(4):263–5.
16 17
18. Chabchoud K, Fakhfakh H, Sahnoun A, Bahloul A, Mhiri M. Mitrofanoff continent urinary diversions: The opinion of 57 patients. Prog Urol. 2006;16(5):578–83.
18 19 20
19. Marshall I, Bissada N. Study of the unaltered in situ appendix as a native continence mechanism: cadaveric and clinical correlation. J Investig Surg. 1995;8(2):147–52.
21 22 23
20. Santucci R, Park C, Mayo M, Lange P. Continence and urodynamic parameters of continent urinary reservoirs: comparison of gastric, ileal, ileocolic, right colon, and sigmoid segments. Urology. 1999;54(2):252–7.
24 25 26 27 28 29 30 31
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Table 1: Demographics and outcomes of MPI patients
Accepted Article
1
PARAMETER
Gender Male Female Age, years (mean ± SD)
Indication for CCUD
Type of conduit channel
Type of reservoir
NUMBER
SUCCESS
PARTIAL
TOTAL (%)
SUCCESS
3 4
0 3
0 9
0 (0) 12 (57)
9 6 4 2 2
2 0 1 0 0
2 3 2 2 0
4 (44.4) 3 (50.0) 3 (75.0) 2 (100) 0 (0)
1 6 9 8 6 2 2 5 7
0 0 1 2 0 0 1 0 1
0 4 3 2 2 0 1 4 1
0 (0) 4 (66.7) 4 (44.4) 4 (50.0) 2 (33.3) 0 (0) 2 (100) 4 (80.0) 2 (28.6)
2
1
1
2 (100)
54.7 ± 10.9 Neuropathic Atonic bladder Complex incontinence Cancer Idiopathic detrusor overactivity Bladder pain Appendix Monti Double-Monti Native Neobladder Ileum Colon Ileocolonic Clam Ileum cystoplasty (Native tunnel) Colon (Native tunnel)
2 3 4 5
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Accepted Article
1 2
Table 2: Further measures required OUTCOME
FOLLOWING MPI (N=24)
Complete success
Partial success
Failure
NUMBER
3
%
FURTHER MEASURES
12.5
No further intervention required 4
9
37.5
1 4
6
2 12
50.0 1
2 1
Maintained with MPI alone New Mitrofanoff resulting in complete continence Revision of channel
2: dry 1: persistent small leak 1: long-term catheter
Channel revision
2: dry 2: channel taken down and urethral voiding reestablished 2: ileal conduit
New Mitrofanoff but persistent incontinence Botox + bladder neck closure resulting in complete (urethral) continence and manageable (minimal) Mitrofanoff leak Manageable leak Long-term catheter
Ileal conduit
3 4
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Accepted Article
1 2
Figure 1: Success rate of MPI according to type of conduit channel and reservoir
3
4 5 6 7
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11
1 2 3
Long-term efficacy of polydimethylsiloxane (Macroplastique®) injection for Mitrofanoff leakage after continent urinary diversion surgery1
4 5
A Kass-Ilya1, TG Rashid1, I Citron1, C Foley2, R Hamid1,TJ Greenwell1, PJR Shah1, JL Ockrim1
6
1University
7
2Lister
8
Corresponding author: Jeremy L Ockrim, [email protected]
College London Hospital, 235 Euston Road, London, NW1 2BU
Hospital, Coreys Mill Lane, Stevenage, Hertfordshire, SG1 4AB
9 10 11 12 13 14 15 16 17 18
Corresponding Address:
19
Abstract
20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
To assess the long-term efficacy of polydimethylsiloxane (Macroplastique®) injection (MPI) in the treatment of Mitrofanoff leakage secondary to valve incompetence.
Department of Urology University College London Hospital Ground Floor Central 250 Euston Road London NW1 2PG Telephone: 0203 447 7080 Fax: 0203 447 9303
Patients and methods Between 1995 and 2012, the records of 24 consecutive patients who underwent MPI for Mitrofanoff urinary leakage after continent cutaneous urinary diversion (CCUD) surgery were examined. All patients had a valve deemed of sufficient length (>2cm) to attempt Macroplastique® coaptation. Treatment outcomes were divided into three categories based on physician assessment: success (dry), partial success (>50% reduction in incontinence pads) and failure. Success rates were assessed according to the type of reservoir and conduit channel. Results
Mean follow-up was 30 months (range 6-96). 1 patient had initial difficulty catheterising, and subsequently required major revision surgery. 12 patients (50%) failed the treatment and subsequently underwent operative revision to the channel. 3 patients (12.5%) achieved complete success; 1 patient had an appendix channel through native bladder and the remaining 2 had Monti channels This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/bju.12817
This article is protected by copyright. All rights reserved.
1
through colon. 9 patients (37.5%) had partial success; success rates were higher with appendix channels (4/6) (67%) and colonic reservoirs (6/7) (86%) when compared with Monti channels (8/18) (44%) and ileal reservoirs (0/2) (0%). 5/9 patients with partial success eventually required further surgical revision for deteriorating continence at a mean of 41 months (range 14-96) whilst the other 4 have maintained sufficient continence with MPI alone.
Accepted Article
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Conclusion Macroplastique® bulking cured only 12.5% patients, but leakage was substantially improved in a further 37.5% allowing major surgery to be avoided or postponed in one half of the cohort. Appendix Mitrofanoffs do better than the Monti Mitrofanoff, with channels through colonic segments generally doing better than those through ileal bladders. MPI should be considered as a less invasive alternative to avoid or delay major reconstructive surgery.
16 17
Introduction
18 19 20 21 22 23 24 25 26 27 28
The continent cutaneous urinary diversion (CCUD) is an integral part of the reconstructive surgeon’s armamentarium. Introduced in 1976 by paediatric surgeon Paul Mitrofanoff (1), the technique involves the use of the appendix as a catheterisable conduit between the skin and the native or reconstructed bladder. Subsequently adaptations have been plentiful: popular variations include the Yang-Monti technique, the double-Monti tube and the spiral Monti all of which employ an ileal tube (2,3). As originally described, the Mitrofanoff was utilised in children with congenital or neuropathic bladder dysfunction. As a result, the majority of our outcome data arises from the paediatric population. It has gained popularity for use in specialist units in the adult population following cystourethrectomy for urothelial cancer, neuropathic bladder dysfunction, complex incontinence and pain syndromes.
29 30 31 32 33 34
The CCUD is a highly specialised intervention with a significant rate of complication and surgical revision. Mitrofanoff complications include: problems with catheterisation, stomal stenosis (0-57%) and incontinence (0-50%) (4-6). Revisions of the channel, either at the skin level or requiring laparotomy, have been reported in up to 75.2% (7). Incontinence due to valve incompetence commonly requires open revision of the channel.
35 36 37 38 39 40 41 42
Injection of bulking agents into the native urethra is a recognized treatment modality for (female) stress incontinence. It acts by creating sub-mucosal cushions that improve urethral coaptation (8). Bulking agent injection has a reported short-term success rate of 75% with complete continence in 43% of patients (9). The use of bulking agents to successfully coapt the Mitrofanoff valve is often anecdotally mentioned, but is little reported in the medical literature (10-14). We assess the efficacy of polydimethylsiloxane (Macroplastique®) injection (MPI) in the treatment of Mitrofanoff leakage secondary to valve incompetence.
43 44
This article is protected by copyright. All rights reserved.
2
Accepted Article
1 2
Patients and Methods
3 4 5 6 7 8
We retrospectively evaluated the records of 24 consecutive patients who underwent MPI for urinary leakage following CCUD between 1995 and 2012. All patients had clinically apparent Mitrofanoff leakage, confirmatory pad testing, and videourodynamics to exclude significant other causes (detrusor / neobladder overactivity or poor compliance) for their incontinence. All patients had a valve deemed of sufficient cystoscopic length (>2cm) to attempt Macroplastique® coaptation.
9 10 11 12 13 14 15 16 17
MPI injections were performed by two reconstructive surgeons (PJRS and JLO) with expertise in Mitrofanoff management. The Mitrofanoff channel was visualised through an 11.5F paediatric or 17F Miller cystoscope, using both antegrade stomal, and retrograde urethral approaches where possible. MPI injections were performed using antegrade access using a 5F William needle through the channel. Submucosal cushions were placed at the reservoir-conduit junction and along the conduit as described by Guys et al (11), with injected volumes ranging between 2.5-5 millilitres, until satisfactory visual coaptation was achieved. All patients had post-procedural (urethral or 8-10F Mitrofanoff) catheter drainage for 24 hours.
18 19 20 21 22 23 24 25 26 27
Patients were interviewed in an outpatient setting post-operatively at 6 weeks and 3 months. The number of pads used during 24 hours and the frequency of leakage between catheterization was used to assess incontinence. Treatment outcomes were divided into three categories based on physician assessment: success, partial success and failure. Treatment was considered a success if patients were dry between catheterization and did not use any pads during 24 hours; partial success was defined as a >50% improvement in the frequency of leakage between catheterization or 50% reduction in the number of daily pads used. Failure was assigned if these criteria were not reached. Success rates were assessed according to the type of reservoir and conduit channel.
28 29
The follow-up period was defined as the date of the MPI until the last recorded visit or until the date of any major interventional surgery if earlier.
30 31 32 33 34 35
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3
Results
3 4 5 6 7
Twenty-four patients (21 female; 3 male) underwent endoscopic MPI with mean followup of 30 months (range 6-96). 23/24 patients were discharged within 24 hours. 1 patient had a protracted stay due to difficulty catheterising the CCUD, and subsequently required major revision surgery of the stoma. There were no other (infection, pain, bleeding) associated complications of MPI injection.
8 9 10 11 12 13 14
Original indications for CCUD were: neuropathic bladder (9), atonic bladder (6), complex incontinence (4), cystourethrectomy for urothelial cancer (2), idiopathic detrusor overactivity (2) and bladder pain (1). 6/24 patients had a CCUD tunnelled into a native bladder and 9/24 had the Mitrofanoff channel tunnelled through the bladder segment of an augmented ileo or colonic cystoplasty. 9/24 had the channel tunnelled into the colonic or ileal segment of a neobladder. The type of channel used was appendix in 6 cases, Monti ileal tube in 9 cases, double-Monti ileal tube in 9 cases.
15 16 17 18 19 20 21 22 23 24
Demographics and outcomes are summarised in Table 1 and Figure 1. 3/24 (12.5%) patients achieved complete success (continence) after MPI at a mean follow-up of 66 months (range 32-96). 9/24 (37.5%) reported partial success. The remaining 12/24 patients (50%) did not respond to the treatment. Of the 3 patients who reported complete success, 1 had an appendix channel tunnelled to native bladder and the remaining 2 had Monti channels tunnelled to colon. Of those 9/24 who reported partial success, continence was more likely with appendix channels (4/6, 66%) and colonic reservoirs (6/7, 86%) when compared with Monti channels (8/18, 44%) and ileal tunnels (0/2, 0%) (Figure 1). The diameter of channel access (11.5 versus 17F), nor post operative Mitrofanoff (rather than urethral catheterisation) did not affect outcome.
Accepted Article
1 2
25 26 27 28 29 30 31
Long-term outcomes are shown on Table 2. All 3 patients who had complete success remain dry. Of the nine patients who had partial success, one continues with the single injection, whereas 3 patients needed a second MPI at a mean time interval of 46 months and one patient underwent a third MPI at 96 months to maintain effectiveness. 5/9 patients with partial success eventually required surgical intervention at a mean followup of 34 months (range 14-96).
32 33 34 35 36
This article is protected by copyright. All rights reserved.
4
Discussion
3 4 5 6 7 8 9
Mitrofanoff incontience is a major complication of reconstructive bladder surgery. The reported rate ranges from 16-61% (3, 15, 16). The psychosocial impact of Mitrofanoff continence should not be underestimated. Successful CCUD continence can restore quality of life to levels comparable to those of the general population (17). Chabchoud et al (18) evaluated 57 patients with Mitrofanoff channels and found that a successful channel enabled 94% of patients to return to work, 79% to return to schooling (where relevant) and 83% to continue a satisfactory sex life.
10 11 12 13 14 15 16 17 18
Incontinence in a CCUD may be due to the bladder or the channel. If related to the bladder, it may be secondary to detrusor overactivity, poor compliance or a reduced capacity. Marshall and Bissada studied the ‘appendiceal leak pressure’ in cadaveric ileocecal pouches. Appendiceal leak occurred at a mean pressure of 50.6cmH20 (range 21-86cmH20) (19). Santucci et al found that CCUDs using a reservoir constructed from right colon with or without ileum provided the best continence whereas stomach and sigmoid had the worst continence rates attributed to decreased capacity, decreased compliance, and a tendency toward high pressure spikes despite detubularization in these tissue types (20).
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Mitrofanoff valve incompetence requires major channel revision surgery or stoma diversion. Injection of bulking agents is the only minimally invasive alternative available. Although anecdotally effective, only five previous papers constituting a total of 30 patients, and with mean follow-up of one year have been published (10-14). The first description by Kaefer et al (10) in 1997 describes successful collagen bulking in one child. Guys el al (11) presented a detailed description of the technique of MPI (similar to ours) for the treatment of incontinent urinary diversion in six patients with neuropathic bladder who had undergone bladder augmentation with four appendix and two Monti Mitrofanoff, and reported success rate of 66.7% complete continence at 11 months. Halachmi et al (12) reported the use of MPI injections in 5 paediatric patients with Mitrofanoff (3 patients Monti; 2 patients appendix) to ileal-augmented native or ileal neobladders. Complete continence was achieved in 3 patients and improvement in 1 patient at 9.2 months (range 2-13). Prieto et al (13) reported one or two injections of Dextranomer Hyaluronic Acid (DHA) in 14 paediatric/adult patients with (12 patients appendix; 2 Monti) channels with a dry rate of 79% at 12 months (range 2-36). In 2008, Welk et al (14) reported the injection of DHA in 4 patients with a success rate of 50%. No clear definition of success or follow-up was provided in the study. Success occurred with the 2 appendix channels and failed in the Monti cases.
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To our knowledge this is the largest series and only study with long-term follow-up on the outcome of MPI in patients with CCUD, and is the first to reconcile treatment outcomes with the underlying aetiology, the reservoir type and the conduit channel type. Although we failed to demonstrate any statistically significant trends, our data suggests that appendix Mitrofanoff channels and colonic reservoirs are likely to mount a better treatment response compared to small bowel Monti conduits and reservoirs, this finding could probably be attributed to the histological characteristics (bowel wall thickness) of the appendix and large bowel compared to the small bowel with the
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former having a markedly thicker walls (3-4 mm) versus (1-2 mm). This could potentially improve both the coaptation and the cushioning effect of the bulking agent.
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Whilst MPI injection only cured 12.5% of patients, 50% of patients responded sufficiently to defer major surgery. With 3 years follow-up, the rate of major interventions after MPI was half (5/12 patients versus 12/12 patients) after a successful treatment, with potential advantages for patient’s quality of life.
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Conclusions
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Macroplastique bulking cured only 12.5% patients, but leakage was substantially improved in a further 37.5% allowing major surgery to be deferred in half of the cohort. Appendix Mitrofanoff (67%) may do better than Monti Mitrofanoff (44%); with channels through colonic segments (80%) generally doing better than those through native or ileal bladders (43%). MPI is a simple, minimally invasive procedure which should be considered as an alternative to avoid or delay major reconstructive surgery in Mitrofanoff leakage secondary to valve incompetence.
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Conflicts of Interest
21
None disclosed.
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References
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1. Mitrofanoff P. Trans-appendicular continent cystostomy in the management of the neurogenic bladder. Chir Pediatr. 1980;21(4):297–305.
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2. Farrugia M, Malone P. Educational article: The Mitrofanoff procedure. J Pediatr Urol. 2010;6(4):330–337.
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3. Woodhouse C, MacNeily A. The Mitrofanoff principle: expanding upon a versatile technique. Br J Urol. 1994;74(4):447–53.
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4. Hautmann R, Volkmer B, Schumacher M, Gschwend J, Studer U. Long-term results of standard procedures in urology: the ileal neobladder. World J Urol. 2006;24(3):305–14.
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5. Wiesner C, Stein R, Pahernik S, Hahn K, Melchior S, Thuroff J. Long-term followup of the intussuscepted ileal nipple and the in situ, submucosally embedded appendix as continence mechanisms of continent urinary diversion with the cutaneous ileocecal pouch (Mainz pouch I). J Urol. 2006;176(1):155–9; dicsussion 159–60.
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6. Sahadevan K, Pickard RS, Neal DE, Hasan TS. Is continent diversion using the Mitrofanoff principle a viable long-term option for adults requiring bladder replacement? BJU Int [Internet]. 2008 Jul [cited 2013 Dec 21];102(2):236–40. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18279448
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7. Veeratterpillay R, Morton H, Thorpe A, Harding C. Reconstructing the lower urinary tract: The Mitrofanoff principle. Indian J Urol. 2013;29(4):316–321.
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8. Pickard R, Reaper J, Wyness L, Cody DJ, McClinton S, N'Dow J. Periurethral injection therapy for urinary incontinence in women. The Cochrane database of systematic reviews. 2003(2):CD003881. Epub 2003/06/14.
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9. Ghoniem GM, Miller CJ. A systematic review and meta-analysis of Macroplastique for treating female stress urinary incontinence. International urogynecology journal. 2013;24(1):27-36. Epub 2012/06/16.
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10. Kaefer M, Tobin MS, Hendren WH, Bauer SB, Peters CA, Atala A, Colodny AH, Mandell J, Retik AB. Continent urinary diversion: the Children's Hospital experience. J Urol. 1997 Apr;157(4):1394-9.
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11. Guys JM, Fakhro A, Haddad M, Louis-Borrione C, Delarue A. Endoscopic cure of stomal leaks in continent diversion. BJU international. 2002;89(6):628-9. Epub 2002/04/12.
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12. Halachmi S, Farhat W, Metcalfe P, Bagli DJ, McLorie GA, Khoury AE. Efficacy of polydimethylsiloxane injection to the bladder neck and leaking diverting stoma for urinary continence. The Journal of urology. 2004;171(3):1287-90. Epub 2004/02/10.
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13. Prieto JC, Perez-Brayfield M, Kirsch AJ, Koyle MA. The treatment of catheterizable stomal incontinence with endoscopic implantation of dextranomer/hyaluronic acid. The Journal of urology. 2006;175(2):709-11. Epub 2006/01/13.
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14. Welk BK, Afshar K, Rapoport D, MacNeily AE. Complications of the Catheterizable Channel Following Continent Urinary Diversion: Their Nature and Timing. J Urol. 2008;180(4):1856–1860.
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15. Harris C, Cooper C, Hutcheson J, Snyder H 3rd. Appendicovesicostomy: the mitrofanoff procedure-a 15-year perspective. J Urol. 2000;163(6):1922–6.
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16. McAndrew HF, Malone PSJ. Continent catheterizable conduits: which stoma, which conduit and which reservoir? BJU Int [Internet]. 2002 Jan;89(1):86–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11849168
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17. Smith G, Carroll D, Mukherjee S, Aldridge R, Jayakumar S, McCarthy L, et al. Health-related quality of life in patients reliant upon mitrofanoff catheterisation. Eur J Paediatr Surg. 2011;21(4):263–5.
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18. Chabchoud K, Fakhfakh H, Sahnoun A, Bahloul A, Mhiri M. Mitrofanoff continent urinary diversions: The opinion of 57 patients. Prog Urol. 2006;16(5):578–83.
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19. Marshall I, Bissada N. Study of the unaltered in situ appendix as a native continence mechanism: cadaveric and clinical correlation. J Investig Surg. 1995;8(2):147–52.
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20. Santucci R, Park C, Mayo M, Lange P. Continence and urodynamic parameters of continent urinary reservoirs: comparison of gastric, ileal, ileocolic, right colon, and sigmoid segments. Urology. 1999;54(2):252–7.
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Table 1: Demographics and outcomes of MPI patients
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PARAMETER
Gender Male Female Age, years (mean ± SD)
Indication for CCUD
Type of conduit channel
Type of reservoir
NUMBER
SUCCESS
PARTIAL
TOTAL (%)
SUCCESS
3 4
0 3
0 9
0 (0) 12 (57)
9 6 4 2 2
2 0 1 0 0
2 3 2 2 0
4 (44.4) 3 (50.0) 3 (75.0) 2 (100) 0 (0)
1 6 9 8 6 2 2 5 7
0 0 1 2 0 0 1 0 1
0 4 3 2 2 0 1 4 1
0 (0) 4 (66.7) 4 (44.4) 4 (50.0) 2 (33.3) 0 (0) 2 (100) 4 (80.0) 2 (28.6)
2
1
1
2 (100)
54.7 ± 10.9 Neuropathic Atonic bladder Complex incontinence Cancer Idiopathic detrusor overactivity Bladder pain Appendix Monti Double-Monti Native Neobladder Ileum Colon Ileocolonic Clam Ileum cystoplasty (Native tunnel) Colon (Native tunnel)
2 3 4 5
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Table 2: Further measures required OUTCOME
FOLLOWING MPI (N=24)
Complete success
Partial success
Failure
NUMBER
3
%
FURTHER MEASURES
12.5
No further intervention required 4
9
37.5
1 4
6
2 12
50.0 1
2 1
Maintained with MPI alone New Mitrofanoff resulting in complete continence Revision of channel
2: dry 1: persistent small leak 1: long-term catheter
Channel revision
2: dry 2: channel taken down and urethral voiding reestablished 2: ileal conduit
New Mitrofanoff but persistent incontinence Botox + bladder neck closure resulting in complete (urethral) continence and manageable (minimal) Mitrofanoff leak Manageable leak Long-term catheter
Ileal conduit
3 4
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Figure 1: Success rate of MPI according to type of conduit channel and reservoir
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