Short Term Results of Minimally Invasive Outpatient Local Anaesthetic Administration of Botulinum Toxin-A for Idiopathic Detrusor Overactivity (IDO)
R.B. POPAT*, A. APOSTOLIDIS*, G. GONZALES*, T. YAP*, C.J. FOWLER* and P. DASGUPTA†
*Department of Uro-Neurology, The National Hospital for Neurology; †GKT School of Medicine and Guys & St. Thomas Hospital, UK
INTRODUCTION
We have been using a flexible cystoscope to
inject Botulinum toxin-A as an outpatient
procedure into the detrusor muscle and
present our results of treating patients with
severe IDO.
METHOD
Under antibiotic cover, 200 units of Botox®
diluted in 20 ml of normal saline were
injected over 20 injection sites along the
dome, lateral and posterior walls of the
bladder, sparing the trigone. The procedure
took 20 min and patients were asked to rate
discomfort on a scale of 0-10.
RESULTS
Eighteen patients (10 men) have been treated,
mean age 47.0 ± 1.08 years. The mean
discomfort score was 3.09 ± 0.28. There was a
statistically significant improvement in the
LUTS at 4 (n = 17) and 16 weeks (n = 14). One
patient developed a UTI and two patients have
needed to start CISC.
The maximum cystometric capacity (ml)
increased form 196.9 ± 23.6 to 385.8 ± 41.7
at 4 weeks and to 355.0 ± 44.5 at 16 weeks.
The maximum detrusor pressure (cmH2O)
during filling reduced from 65.5 ± 10.4 to
38.1 ± 7.97 at 4 weeks and to 35.4 ± 5.77 at
16 weeks.
The leak episodes in 24 hours reduced
from 5.03 ± 1.19 to 0.63 ± 0.21 at 4
weeks and to 0.57 ± 0.3 at 16 weeks. The
frequency of voiding reduced from
13.6 ± 0.96 to 7.71 ± 0.73 at 4 weeks and to
7.6 ± 0.82 at 16 weeks. The beneficial effects
last for 9 months when injections are
repeated.
CONCLUSION
Injections of botulinum toxin are well
tolerated using our technique and is an
effective alternative treatment for patients
with intractable IDO.
P044
Short Term Results of Minimally Invasive Outpatient Local Anaesthetic Administration of Botulinum Toxin-A for Neurogenic Detrusor Overactivity (NDO)
R.B. POPAT*, A. APOSTOLIDIS*, T. YAP*, G. GONZALES*, C.J. FOWLER* and P. DASGUPTA†
*Department of Uro-Neurology, The National Hospital for Neurology; †GKT School of Medicine and Guys & St. Thomas Hospital, UK
INTRODUCTION
We have been using a flexible cystoscope to
inject botulinum toxin-A as an outpatient
procedure into the detrusor muscle and
present our results of treating patients with
severe NDO.
METHOD
Under antibiotic cover, 300 units of Botox®
diluted in 30 mL of normal saline were
injected over 30 injection sites along the
dome, lateral and posterior walls of the
bladder, sparing the trigone. The procedure
took 20 minutes and patients were asked to
rate discomfort on a scale of 0-10.
RESULTS
Thirty-two patients (9 men) have been
treated, mean age 49.2 ± 2.08 years. The
mean discomfort score was 3.09 ± 0.28.
There was a statistically significant
improvement in the LUTS at 4 (n = 29) and
16 weeks (n = 20). Two patients developed a
UTI and 2 patients have needed to start CISC.
The rest of the patients already performed
CISC.
The maximum cystometric capacity (mL)
increased from 232.8 ± 25.6 to 534.4 ± 28.9
at 4 weeks and to 405.9 ± 32.4 at 16 weeks.
The maximum detrusor pressure (cmH2O)
during filling reduced from 56.8 ± 6.9 to
27.0 ± 3.76 at 4 weeks and to 26.7 ± 3.63 at
16 weeks.
The leak episodes in 24 hours reduced from
3.89 ± 0.63 to 0.5 ± 0.17 at 4 weeks and to
0.8 ± 0.23 at 16 weeks. The frequency of
voiding reduced from 12.6 ± 0.74 to
6.32 ± 0.72 at 4 weeks and to 7.09 ± 0.8 at 16
weeks.
CONCLUSION
Injections of botulinum toxin are well
tolerated using our technique and is an
effective alternative treatment for patients
with intractable NDO.
P045
Changes in Human Bladder Suburothelial Innervation Following Treatment of Detrusor Overactivity with Intra-detrusor Botulinum Toxin Injections
A. APOSTOLIDIS*, R. POPAT*, J.B. DAVIS†, P. DASGUPTA‡, C.J. FOWLER* and P. ANAND§
*National Hospital for Neurology, Department of Uro-Neurology; †Neurology and GI Centre, GlaxoSmithKline, Harlow; ‡Guy's and St. Thomas Hospitals, Department of Urology; §Hammersmith Hospital, Imperial College London, UK
INTRODUCTION
We aimed to examine the mechanism of
action of intra-detrusor injections of
botulinum toxin type A (BoTx/A) in intractable
detrusor overactivity (DO) by studying the
immunohistochemical changes in the
suburothelial innervation in treated
patients.
PATIENTS AND METHODS
Flexible cystoscopic bladder biopsies were
obtained from 36 patients (22 neurogenic DO,
14 idiopathic DO) before and during sustained
improvement at 4 and 16 weeks after
treatment with BoTx/A injections. Control
tissue was obtained from 11 stable bladders.
Specimens were incubated with specific
antibodies to the pan-neuronal marker
PGP9.5, the afferent marker TRPV1 (vanilloid
receptor), and the cholinergic marker
acetylcholinesterase (AChE). P-values
<0.05 were considered statistically
significant.
RESULTS
Mean ± SEM density of PGP9.5 (+) fibres
remained unchanged at 4/52 post BoTx/A
(1.85 ± 0.22 vs pre: 2.04 ± 0.24, P = 0.39), and
at 16/52 (1.63 ± 0.22, P = 0.35). No change
was found in AChE (+) nerve fibres at 4/52
(0.91 ± 0.15 vs baseline: 0.96 ± 0.14) or at
16/52 follow-up (0.68 ± 0.16, P=0.18;
controls: 0.72 ± 0.25). However, TRPV1-
expressing fibres decreased at 4/52 post-
BoTx/A (0.47 ± 0.11 vs 0.27 ± 0.05), but more
significantly at 16/52 (0.11 ± 0.04, P = 0.0004)
to controls' levels (0.17 ± 0.09).
CONCLUSIONS
Absence of substantial suburothelial neuronal
or cholinergic fibre degeneration, together
with the significant decrease of TRPV1
expressing fibres, or of their level of TRPV1
expression, in overactive bladders successfully
treated with BoTx/A suggest that the clinical
response of such patients may be partly the
result of alterations in the suburothelial
afferent mechanisms.
P046
Urgemeter Cystometry - Urodynamic Assesment of Urgency and the Relationship of Urge to Detrusor Overactivity
J.A. MOORE*, J.G. NOBLE* and A.F. BRADING†
*Churchill Hospital, Oxford; †University of Oxford, UK
INTRODUCTION
Bladder sensations are difficult to evaluate
because of their subjective nature. The aim of
this experiment is to develop better methods
for assessing patient's sensations, particularly
urgency, during urodynamics and evaluate
the relationship between urgency and
intravesical pressure change without the need
for clinician to patient dialogue which may
introduce bias and error.
PATIENTS AND METHODS
We designed the urgemeter which consists of
a compressible hand held device connected
by air filled cystometry tubing to a spare
pressure transducer inputting to standard
urodynamic hardware. Patients were
instructed to squeeze the device if they
experienced urgency and the stronger the
urge the harder they should squeeze. This
gave a continuous tracing of the patients urge
alongside other cystometric data during
artificial filling using standard urodynamic
techniques.
RESULTS
22 patients with overactive bladder
underwent urgemeter cystometry. Patients
found the device extremely simple to use and
the relationship between urgency and
intravesical pressure was easy to interpret.
13/22 patients had urgency during filling with
no increase in Pdet. Interestingly nine of these
complained of urge incontinence for which
one might expect unstable contractions.
7/22 patients had urgency, five of which
demonstrated a close temporal relationship
between phasic increases in Pdet and urgency,
urge preceding pressure rise in all. Two
patients had normal cystometrograms and no
urgency.
CONCLUSIONS
This prototype facilitates patient recording of
urgency during cystometry and introduces
objectivity into the assessment of sensation
during artificial filling. For the majority of
patients detrusor pressure increase was
not prerequisite for the sensation of
urgency.
P047
Comparison of Transurethral Collagen Injection and Perineal Bone-anchored Male Sling for the Treatment of Intrinsic Sphincter Deficiency
A. SINGLA and R. ONUR
Wayne State University, Department of Urology
PURPOSE
In the present study we compared the efficacy
of collagen injection and bone-anchored male
sling in the treatment of post-prostatectomy
incontinence.
PATIENTS AND METHODS
Two cohorts of men, one which received
transurethral collagen injection (group 1) and
one perineal bone-anchored male sling (group
2) using In-Vance bone drill (American Medical
Systems, Minnetonka, MN, USA) were
examined. Patient characteristics, mean
injection of collagen, mean cumulative volume,
post-operative outcome and complications
were noted. Efficacy of the procedures were
compared between two groups.
RESULTS
A total of 34 incontinent patients (mean age
69), received a mean of 2.1 injections of
collagen (mean cumulative volume injected 9
ml.) whereas, thirty-seven men, (mean age 71)
underwent male sling. Preoperatively, patients
required a mean of 5.5 and 4.2 (1-10) pads
per day, respectively. Mean follow-up was 15
vs. 18 months. There was no difference
between two groups with respect to postoperative
complications, i.e. urinary retention,
de novo urge/urge incontinence, infection
and urethral erosion (P < 0.001).
Postoperatively, five patients (15%) were dry
and 4 (12%) were improved in group 1,
whereas 15 (41%) patients in group 2 were
cured and 13 (35%) improved. The success
rates for collagen and male sling were 27%
and 76%, respectively. There was a significant
difference between two groups (P < 0.05).
CONCLUSION
Our results demonstrate that patients who
undergo male sling placement for mild to
moderate incontinence are more likely to be
completely continent and also have a much
higher rate of improvement compared with
patients treated with collagen injections.
However, further studies are needed to define
long term success.
P048
Sling Surgery for Stress Urinary Incontinence: Feasibility and Safety of a Day-case Approach
S.K. GIRI*, J. MAC DONALD*, J.P. HICKEY*, H.P. REDMOND†, J. DRUMM* and H.D. FLOOD*
*Regional Hospital and NIHS, University of Limerick, Ireland; †University College Hospital, Cork, Ireland
AIM
To assess in a prospective fashion the
feasibility for discharge at 10 h following
xenograft (Pelvicol) pubovaginal sling
procedure.
MATERIALS AND METHODS
Between June 2003 and November 2003,
30 consecutive patients with stress
urinary incontinence (SUI) were enrolled
prospectively. Patients were admitted with a
planned overnight stay and returned to the
ward after operation without urinary catheter.
Patients were assessed at 4, 10 and 24 h
postoperatively. Time interval to first
spontaneous void (TIFV), emptying efficiency
(EE) and suitability for discharge were
assessed. The EE was calculated as EE = VV x
100/ VV + PVR %; VV = voided volume, PVR =
post void residual. Patients were considered
ready for discharge from hospital when EE
was >= 75% or when self-catheterizing
confidently.
RESULTS
The mean TIFV was 7.1 h (median 6, 95% CI =
5.2-8.5). The mean EE at 10 h was 65.5%
(median 60%, 95% CI = 56.8-76.2 %). Twelve
patients (40%) achieved EE >= 75% at 10 h
and another 3 (10%) were able to perform
self-catheterization. Thus, overall 15 patients
(50%) would have been dischargeable at 10 h.
Non-dischargeable patients were more likely
to be older (>60years) and to have the
Valsalva leak point pressure of <60 cm of
H2O.
CONCLUSIONS
These data show that 50% of patients are
suitable for day-case sling surgery. Early
postoperative emptying inefficiency and
inability to perform self-catheterization are
the main limiting factors. Careful patient
selection based on age and urodynamic
findings may improve the feasibility of daycase
sling surgery.
P049
Prospective Randomized Trial of Xenograft Versus Rectus Fascia Pubovaginal Sling in the Treatment of Stress Incontinence
S.K. GIRI, O. CLYNE, J.P. HICKEY, G. NARASIMHULU, J. DRUMM and H.D. FLOOD
Regional Hospital and NIHS, University of Limerick, Ireland
INTRODUCTION AND OBJECTIVE
The pubovaginal fascial sling operation has
become the first line surgical treatment for
stress urinary incontinence (SUI). We
compared the early morbidity and longer term
efficacy of the rectus fascia sling with that
of the xenograft sling in the treatment of
SUI.
METHODS
Between January 2001 and March 2002, 65
patients with SUI were randomly assigned to
either rectus fascia sling (group 1, n = 31) or
xenograft sling (Pelvicol, group 2, n = 34).
Mean age was 49 years. Minimum follow-up
was 18 months (range 18-30). At follow-up
each patient was evaluated by a blinded
assessor. Outcome measures included
postoperative visual analogue pain score
(VAS) (0=no pain, 10=maximum pain), length
of stay, postoperative complications, time to
return to work, persistence or recurrence of
SUI, urge symptoms and subjective
improvement.
RESULTS
The groups were well matched for age, type
of SUI and urge symptoms. The mean
postoperative VAS was 6.18 in group 1 and
2.1 in group 2 (P < 0.001, Wilcoxon rank sum
test). The mean length of stay was 4.9 days vs.
2.8 days (P < 0.01) and the mean time to
return to work was 9.1 weeks vs. 4.5 weeks
(P < 0.001) in group 1 and group 2
respectively. Overall SUI was cured or
significantly improved in 26 patients (83.8%)
in group 1 and 27 patients (79.4%) in group 2
(P > 0.05).
CONCLUSIONS
The xenograft sling offers significant
reduction in early morbidity without
compromising longer term efficacy when
compared with the autologous rectus fascia
sling.
P050
Are TVT Polypropylene Slings Colonized by Muscular Fibres? A Histopathological Evaluation of Resected Tapes for Voiding Dysfunction
J.F. HERMIEU, M. TOUBLANC, B. LHOEST, V. DELMAS, V. RAVERY, L. BOCCON GIBOD and C. BICHAT
Clinique Urologique, Hopital Bichat, Paris, France
PURPOSE
Tension free vaginal tapes (TVT) made of
polypropylene mesh are increasingly used in
the treatment of female stress urinary
incontinence (SUI).
It is claimed by the manufacturer that the
tape will be over time colonized by muscular
fibres which will add their own effect to the
simple mechanical suspension of the distal
urethra. This study was undertaken to check
this hypothesis.
PATIENTS AND METHODS
15 consecutive patients submitted to a TVT for
SUI and suffering from voiding dysfunction
(obstruction/de novo urgency) were treated
by tape resection, 6 to 40 month after
implantation. The resected tapes were
submitted to hispathologic evaluation
using standard stain (HPS) and
immunohistochemistry (Vimentin, Actin, CD8)
to detect the presence of fibroblast and
muscle fibres.
RESULTS
Fibroblast and macrophages were detected
around the fibres of every tape in a quantity
inferior to what is normally seen in foreign
body inflammatory reaction. 13/15 tapes were
colonized by muscular fibres considered to be
rare to abundant with no special relationship
between the duration of implantation and the
number of fibres.
CONCLUSION
This study shows that indeed TVT meshes are
colonized by muscular fibres and induce only
a limited inflammatory reaction. This explains
the good tolerance usually observed. The
exact contribution of muscular fibres to the
recovery of continence remains to be
investigated.
P051
Single Centre Experience of the Monarc™ Subfascial Hammock for the Treatment of Female Stress Urinary Incontinence (SUI)
G.H. URWIN and S. HEATON
York Hospital, UK
INTRODUCTION
The tension-free vaginal tape has become the
most commonly used technique for the
treatment of female SUI. However, its blind
needle passage has been associated with
complications. The transobturator approach
avoids the retropubic space and should result
in decreased complication rates but with
equivalent efficacy.
PATIENTS AND METHODS
Between April and December 2003, 48
patients with SUI were implanted with the
Monarc™ subfascial hammock. Effectiveness
was evaluated objectively by physical
examination, urodynamics, 1-h pad weight
test and subjectively by patient-completed
Urogenital Distress Inventory Short Form
(UDI-6).
RESULTS
Mean age of patients was 55.6 years (range
33-84) 13 patients (27%) had undergone
previous incontinence surgery. The mean
operative time was 20 minutes and all
patients went home without a catheter.
Patients used on average 3.9 pads/day
preoperatively. Pad use decreased to 0.6 pads/
day at 6 weeks and 0.4 pads/day at 3 months.
Preoperative 1-h pad weight tests showed
a mean pad weight of 69 g. Pad weight
decreased to 4.3 g at 6 weeks and 3.9 g at
3 months. Mean UDI-6 scores were 70.1, 17.9
and 15.7 preoperatively, 6 weeks and
3 months, respectively. One urethral
perforation was sustained and 3 patients
developed de novo detrusor overactivity. 2
patients reported slight voiding difficulties at
3 months.
CONCLUSIONS
These early results demonstrate that the
Monarc™ sub fascial hammock is an effective
and safe operation in the treatment of female
SUI and avoids the potential risk of vascular
or intestinal injury particularly in patients
who have had previous pelvic surgery. Further
follow up however, is needed.
P052
Evaluation of the Periurethral Adjustable Continence Therapy (ACT™) Device for the Treatment of Post Prostatectomy Incontinence Results at 1 year
P.J. GILLING, D. BELL, K.M. KENNETT, A.M. WESTENBERG and M.R. FRAUNDORFER
Promed Urology, Tauranga, New Zealand
INTRODUCTION AND OBJECTIVES
The adjustable continence therapy (ProACT™)
device has been designed to provide extrinsic
compression of the membraneous urethra. It
consists of two contralateral balloons each
placed periurethrally, and attached via a
conduit to a subcutaneous port placed in the
scrotum. This enables postoperative balloon
adjustment. We aimed to assess the efficacy
of this device in the treatment of postprostatectomy
incontinence.
MATERIALS AND METHODS
16 post radical prostatectomy (8 perineal and
8 retropubic) and 7 post transurethral
prostatic resection or holmium enucleation
patients have been enrolled and treated to
date. Subjective and objective parameters
including the Incontinence Quality of Life
questionnaire (I-QoL) and pad usage were
measured at baseline and followed up at 1, 3,
6 and 12-month intervals. Urodynamics
studies were conducted at baseline and at
6 months. Perioperative data, number and
volume of adjustments and adverse events
were also recorded.
RESULTS
9 of 14 patients were either cured or
significantly improved at 3 months. No
difficulties were encountered with balloon
placement and there were no perioperative
complications. Mean OR time was 27 (13-48)
min. I-QoL scores increased from a mean
of 51.8 (13.6-94.3) at baseline to 82.4
(29.5-96.6) at 12 months, representing a
significant improvement. Pad usage dropped
from a mean of 2.9 (1-12) at baseline to 0.28
(0-1) at 12 months. 13 out of 20 patients
required a one time balloon adjustment and 7
out of 20 required a secondary adjustment,
one required no adjustment. Two patients did
not respond, and had an AUS placed. There
were 3 infections necessitating implant
removal.
CONCLUSIONS
Most patients (80%) are cured or have a
significant improvement following ACT device
placement for post-prostatectomy
incontinence.
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