Silicone bulking agent – case series

StudyStudy type and ELNo. patientsPatient characteristicsInterventionLength of follow-upOutcome measuresEffect sizeAdditional comments
Henalla 2000566
UK study
Case series
EL = 3
40F > 18 years, UD stress UI, PVR < 100 ml. 70% had no prior continence surgery (no details for other 30%)
Exclusions: neurogenic or unstable bladder, moderate/severe prolapse, previous urethral bulking therapy, history of intra-urethral devices/haematuria
Silicone injection (Macroplastique; transurethral)
5 ml given per tx
3 monthsSuccess at 3 months*19 (48%) at 6 weeks
21 (53%) at 3 months
Funding: none declared. Uroplasty assisted in developing study protocol.
*investigator rating of dry or markedly improved.
Primary aim of study was to evaluate new implantation device for the product.
2.5 ml given at six o’clock position, 1.25 ml at each of 10 and 2 o’clock. 5 ml retreatment offered at 3 months of required (retreatment in 14/19 ‘failures, and 4/13 of the markedly improved grp).
Success at 6 months (after retreatment at 3 months in n = 18)Overall 29/39 (74%)
with mean 1.35 implantations
In retreated grp: 12/17 (71%)
Post-op adverse effects89% mild/moderate pain on implantation (from pain scores)
63% ‘transient haematuria and dysuria’
18% urinary retention > 48 h, 2 with persistent reqd indwelling catheterisation
Usman 1998567
UK study
Case series
EL = 3
102F mean age 59 years (33–83) stress UI (UD diagnosis in 86%)
30% had prior continence surgery (anterior colporrhaphy or Stamey)
Silicone injection (Macroplastique; transurethral), single injection under GA
5 ml given per tx
Mean 3.2 months (3–5)Success (cure or marked improvement)68%
and at mean followup 17.6 (11–44) months (n = 84): 48%
Funding: none declared.
Injn guided by cystoscope, at 6, 3, and 9 o’clock positions.
Cure or marked improvement: no further tx reqd
slight or no improvement: further tx reqd.
Success in subgroupsPrimary vs secondary procedure 66% vs 71%, P = NS
(48% vs 46% at 17.6 months)
Cystocele (n = 26), 69% success, 67% vs 75% for primary vs secondary procedure
Post-op adverse effects100% haematuria and dysuria for 24–48 h
7% urinary retention for 2–7 days, 0 reqd indwelling catheter
Gurdal 2002568Case series (retrospective chart review)
EL = 3
29F mean age 57 (48–79), stress UI owing to ISD (52%) or ISD and hypermobility (48%)
Stamey grade 1 (7%), 2 (28%), 3 (66%)
62% had prior continence surgery (10 bladder neck suspension, 5 anterior colporrhaphy, 2 retropubic urethropexy, 1 in situ vaginal wall sling placement)
Exclusions: genital prolapse, moderate/severe cystocele, DO, bladder capacity ≤ 250 ml, neurologic disorders, bladder outlet obstruction, urge UI, detrusor hypocontractility
Silicone injection (Macroplastique), per-urethral
Single injection
Mean 29 months (24–36)ContinenceAt 3 months:
55% cure
24% improvement ( > 50% vs baseline)
21% failure
At 24 months:
45% cure
17% improvement
41% failure
Funding: none declared
Injection guided by cystoscope.
Mean vol. injected 3.5 ml (3–5) at 4 and 8 o’clock positions (and12 o’clock if necessary) to achieve satisfactory coaptation. No repeat injection given.
Post-op complications (all transient)45% haematuria
79% dysuria
72% frequency
3% temporary retention
Sheriff 1997569
UK study
Case series (consecutive pts)
EL = 3
34F mean age 53 years (26–77), stress UI on video-urodynamics, failed prior continence surgery. 94% had ISD. 21% also had vesical descent, 6% had neurogenic bladderSilicone injection (Macroplastique)
5 ml dose
1–36 monthsContinence‘success’ (dry or rare leakage, not requiring protection): 90% at 1 month, 75% at 3 months, 48% at 2 years*Funding: none declared.
One surgeon undertook all procedures.
Inj. given under LA or GA or spinal anaesthetic, at 3, 6, 8, (and12 if necessary) o’clock positions.
*failed in all F with bladder descent/ neurogenic UI.
18% had re-injection after at least 3 months.
ComplicationsAll transient (resolved within 36 h):
12% retention
53% dysuria
68% haematuria
76% frequency
Radley 2001570Case series (Prospective)
EL = 3
60F mean age 53 years (26–81), stress UI owing to ISD (shown on video UD)
68% prior continence surgery, 40% prolapse repair, 60% prior hysterectomy
Silicone injection (Macroplastique, transurethral)
Up to 3 inj.
Mean 19 months (6–50)Subjective outcome (telephone q), n = 5620% cured
39% improved (no definition)
41% unchanged or worse
Funding: none declared.
One surgeon.
Inj. under cystoscope guidance at 3 or more sites (2, 6, 10 o’clock positions). 2 further tx offered if initial unsuccessful (43% had 2nd, 3% a 3rd).
Mean vol. at each tx 6.73 ml (3.5–10).
Mean 16 months (6–52)Objective outcome (video UD), n = 41Of 17 improved/cured after inj., 9 were cured on video UD
Post-opComplications6% UTI
12% acute retention
Tamanini 2003571 (1 year follow-up) and 2004572 (2 year follow-up)Case series (consecutive cases)
EL = 3
21F mean age 47 years (33–54) with UD stress UI, Stamey grade 2, owing to ISD (VLPP < 90). 81% also had frequency, and 48% urgency
Mean duration UI 12 years (2–220. 19% had prior continence surgery
Exclusions: prior injection therapy, nocturnal enuresis, severe genital prolapse, neurogenic bladder
Silicone injection (Macroplastique, peri-urethral)1 and 2 yearsSubjective cure (Stamey grade 0)Pt vs surgeon opinion:
57% vs 38% at 1 year
48% both at 2 years
Funding: Uroplasty provided the injection system.
All pts treated by single surgeon on a day case basis, under LA. Inj. at 3 sites via implanter device.
8 (38%) had 2nd inj. at 3 months. Mean vol. injected 6.3 ml (SD 1.9 ml).
Objective cure1 h pad test (at 1 year only):
62% cure
19% improved (≥ 50% reduction)
19% failed
UD (VLPP), n = 20:
40% cured at 1 year
50% cured at 2 years
KHQSig. improvements in all domains at 1 and 2 years
Adverse effects100% transient dysuria and pain at implant site
10% transient retention
3% (n = 1) loss of material though injection site
Barranger 2000573Case series
EL = 3
21F median age 68 years (46–83) stress UI owing to ISD (MUCP < 30). 6 (29%) also had bladder neck mobility.
All had prior continence or prolapse surgery
Silicone injection (Macroplastique, trans-urethral)1, 16 and 31 monthsSubjective cure/ improvementAt 1 month:
2 (10%) dry
9 (42%) improved
10 (48%) failed
At 16 and 31 months:
2 (10%) dry
8 (38%) improved
11 (52%) failed*
Funding: none declared.
Inj. under LA, by cystoscope guidance at 3 points. Mean vol. injected not stated. 2 (10%) had 2nd injection at 3 and 5 months.
*including 2 who had repeat injection.
Stamey gradingChange of ≥ 1:
Fell in 43% at 16 months, 62% at 31 months
unchanged in 52%, 38%
increased in 5%, 0
MUCPNo sig. change from baseline at 1 month (−4%)
Adverse effectsNone during or after surgery
Koelbl 1998574Case series
EL = 3
32F mean age 64 years (39–85) stress UI owing to ISD (VLPP < 65).
88% had ≥ 1 prior continence surgery (colposuspension, anterior colporrhaphy, slings)
Exclusions: genital prolapse, neurologic disorders, PVR > 50 ml, UTI, DO
Silicone injection (Macroplastique, trans-urethral)
6 and 12 monthsCure (subjective and objective [clinical stress test])75% at 6 months
59% at 12 months
Funding: none declared.
Inj. under GA, by cystoscope guidance at 3 points. Mean 3.9 ml (1.5–15 ml) used to occlude urethra. 4 (13%) had 2nd injection at 3 months.
MUCP at rest (at 12 months)+26% (from 25 cmH2O), P = 0.027 vs baseline
Adverse effects6% (n = 2) transient UTI
Mean time to PVR < 50 ml 3.4 days (1–7)
No pts had de novo DO
Harriss 1996575
UK study
Case series
EL = 3
40F median age 50 years (27–74) UD stress UI. 38% had prior continence surgery
Exclusions: DO
Silicone injection (Macroplastique, peri-urethral)
3 months and 3 yearsSubjective cure/ improvement3 months:
16 (40%) dry
13 (33%) improved
11 (27%) unchanged
At 3 years:
16 (40%) dry*
7 (18%) improved
17 (42%) unchanged (offered colposuspension)
*includes 4 pts who had 2nd injection at 3 months, thus 4 pts deteriorated from 3 month follow-up
Funding: Bioplasty provided materials free of charge.
Inj. as day case under GA.
Inj. by cystoscope guidance at 4 points. 2–7 ml per inj. (actual vol. injected not stated). 4 (10%) had 2nd injection at 3 months.
25 had UD at 3 months – limited data reported. 3 of 3-months ‘improved’ group had DO on UD, successfully treated with anticholinergics.
Adverse effects‘almost all had dysuria at 48 h’

From: Evidence tables for included studies

Cover of Urinary Incontinence
Urinary Incontinence: The Management of Urinary Incontinence in Women.
NICE Clinical Guidelines, No. 40.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2006 Oct.
Copyright © 2006, National Collaborating Centre for Women’s and Children’s Health.

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