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Trans-obturator urethral support for female stress urinary incontinence: 1 year outcome of a new surgical procedure
777 THE TRANSOBTURATOR DANGERS
SLINGTAPE
Delmas V., Hermieu J., Dompeyre Boccon-Gibod L.
URATAPE:
ANATOMICAL
P., Messas A., Dumonceau
0.. Ravcry V.,
778 SEVERE COMPLICATIONS VAGINAL TAPE PROCEDURES Klingler
INTRODUCTION & OBJECTIVES: UraTape is a new minimal invasive treatment for stress urinary incontinence: its original route is transversal through the obturator foramcn. The aim of this study was to search the anatomical dangers of this new transobturator route. MATERIAL & METHODS: 10 female anatomical subjects not embalmed, 74 to 89 old. UraTape was placed with some variations on the level of entrance of the tunneler. Dissection by femoral, perineal or pelvic approach was led to study the anatomical structures possibly injured. RESULTS: Femoral dissection: after crossing the adductor muscles, there are no vessels or nerves at the inferior brim of the obturator foramen. The tape passes at the opposite side of the obturator canal, 4 cm under it. Perineal dissection: The tape is on the space between the perineal membrane and the inferior aspect of the levator ani muscle above the pudendal pedicle in the pudendal canal which is protected by the ischio pubic ramus. Pelvic dissection: The tape is crossing behind the Santorini plexus. When the tunneler is placed more anterior there is a danger for the anterior aspect of the bladder. When the tunneler is placed more posterior, perforation of the vagina is possible as bladder perforation. dONCLUSIONS: The route of UraTape is perineal. There is no risk to injury major vessels or nerves. But vaginal, vesical or urethral injury is possible. To avoid this risk a large lateral dissection has to be performed introduction of the index finger. The index will lead the tunneler’s
allowing
the
tip.
TENSION-FREE-
H., Tinzl C., Marberger J.
Universitiy
Bichat Hospital, Urology, Paris, France
FOLLOWING
of Vienna. Urology, Vienna, Austria
INTRODUCTION & OBJECTIVES: Tension-tree vaginal tapes are used for treatment of stress urinary incontinence. Serious adverse events are believed to be uncommon, as reported in the literature. However, in case of appearance complications may be severe and require immediate invasive intervention. MATERIAL & METHODS: Between 112001 and 812002 6 patients were referred to our institution because of serious adverse events for further consultation. another TVT procedure was performed at this institution. In 617 patients TVT procedure was performed by experts, only one procedure was performed by a beginner. According to the surgical reports, all recommended
safety guidelines were applied and intraoperative findings were uneventful in all patients. 3 procedures were performed under local andesthesia, one with spinal and 3 under general anaesthesia. RESULTS: Severe complications compromised significant haemorrhage (2), tape arosion (I) or dislocation (2) and obstruction (2). Severe haemorrhage required polytransfusion (> 6 blood units), both were hemodynamically unstable and required open surgical revision. Cause of bleeding was venous (I) and arterial bleeding (1) respectively. In both cases the TVT sling was removed and a Burch procedure was performed after local hemostyptic compression and thermal coagulation of the bleeding site. Tape arosion requiring TVT removal and urethral reconstruction. Proximal tape dislocation resulted in obstructive voiding. Surgical intervention with removal of TVT and simultaneous ureterolysis and facial sling correction was performed. One patient with urodynamically proven over-correction is on chronic intermittent catheterisation, despite TVT dissection and urethrolysis. One patient is on intermittent catheterisation due to incomplete bladder emptying, incontinence is still ongoing. CONCLUSIONS: TVT procedures may result in serious adverse events. even in the hand of experts and patients need to be counselled accordingly prior to surgery.
780
779 TRANS-OBTURATOR URETHRAL SUPPORT FOR FEMALE STRESS URINARY INCONTINENCE: 1 YEAR OUTCOME OF A NEW SURGICAI.
COMPETITIVE DARIFENACIN
AND REVERSIBLE INTERACTION WITH HUMAN RECOMBINANT M3 RECEPTORS
PROCEDURE Nuaplcr c‘.. Laakcy P., (iuota
Drouov
OF
S I. De Tayrac R ‘. Dclormc
Ptirer Inc. Discovery ‘CHU Bicetre, Urology, Le Kremhn B&tre, Gynaecology. Clamart. France. ‘Clinic. Urology. INTRODUCTION minimally invasive
& OBJECTIVES: surgical technique
approach
I’.. Clarke N.P.
1; France, ‘Hopital Antoine C‘halon sur Saone, France
We report the feasibility
and results of a new
using a vaginal tape inserted via a transto recreate a mid-urethral backboard for the
obturator
per-cutaneous
treatment
of stress urinary incontinence.
Biology,
Sandwich,
Umted Kingdom
B&l&.
MATERIAL & METHODS: UraTapc% (Porg&Mentor) is a non elastic polypropylene tape, with a silicone coated central part. The tape is placed without any tension under the mid-urethra and extended through the obturator foramen. It reproduces the natural suspension fascia ofthe urethra while preserving the retropubic space. No cystoscopy is required for the procedure. From May 2000 to February 2002. 32 consecutive patients with stress urinary incontinence associated with urethral mobility and without gemtal prolapse were operated. Mean age was 64 years (50-81). All diagnostics were assessed by an urodynamic testing. Four patients had intrinsic sphincter deficiency (~20 cmH,O). Fice patients had recurrent stress mcontinence after Burch or TVT procedures. Urge incontinence was associated in 18132 patients. Quality of life (QoL) assessment was carried out prc and postoperatively. All patients were evaluated for follow up by two independent surgeons: clinical examination, cough stress test, uroflowmcny. Objective and subjective criteria of voiding dysfunction were analysed: Qmaxc I Smlis, residual volume >20%, clinical dysuna, de nova urgencies or recurrent urinary Infections. RESULTS: Mean operative time was 1.5 minutes. No intra-operative complications were observed. Mean follow-up was 12 months (3-23). 27132 patients were completely cured (84.4%) and 5132 patients were significantly improved (I 5.6%). 28132 patients (87,.50/o) expressed good QoL (satisfied /very satisfied). One patient had a regressive postoperative urinary retention. There was no urethral erosion. One vaginal erosion was diagnosed at the time of follow up (23 months after the operation). 3132 patients (9.5 %) presented both objective and subjective criteria of voiding dysfunction. No sexual discomfort was reported.
INTRODUCTION & OBJECTIVES: In the USA. overactive bladder (OAB) with Incontinence has an estimated prevalence of l7?,0 (1). OAB results in social, psychological. sexual. behavioural and financial burden for the patient so effective treatment regimens arc Important. The muscarinic M3 receptor mediates contractile responses to acetylcholine in the bladder and may therefore be a target for the treatment of OAB. The aims of this study were to determine, using radioligand binding techniques, whether darifenacin is a competitive and reversible antagonist at the human recombinant M3 receptor and to compare the binding properties of darifcnacin wnh those of other muscarinic antagonists. MATERIAL & METHODS: These studies were performed using membrane homogenates of Chinese Hamster Ovary cells expressing recombinant human M3 receptors. The effects of the test antagonists on the binding parameters KD and Bmax were determined for [3H]-N-methyl scopolamine ([3H]-NMS) from a 12.point saturation analysis. Non-specific binding was determined using atropine. Using [3H]darifenacm, the rate of association and dissociation from the M3 receptor was also dctermmcd. Data were analyscd using the curve-fitting programs in GraphPad Prism. RESUUI‘S: Darifcnacin (l-10 nM), atropme (0.3-3 nM), tolterodine (l-100 nM) and oxybutynin (l-100 nM) all produced dose-dependent rightward shifts of the [3H]NMS saturation bmding curves without significantly altering the Bmax value (p>O.O5). This indicates that, at the concentrations tested, these compounds bind to the M3 receptor in a competitive manner. In contrast, Bmax values in the presence of 4DAMP mustard (I-IO nM) were significantly reduced (p
CONCLUSIONS: CONCLUSIONS: This proccdurc IS an effective promising new technique for the treatment of female stress urinary incontinence. The trans-obturator approach is safe. avoiding bladder. intestinal or vascular injuries and urinary retention. Further followup is necessary.
These data support findings of previous studies, which have shown that darifenacin has high affinity for the M3 receptor. In addition. these data mdicatc that darifenacin binds to the human recombinant M3 receptor in a competitive and reversible manner, providing further support for its use for the treatment of DAB. I. Milsom I. et al. BJU Int 2001; X7(9): 760-6.
European
Urology
Supplements
2 (2003) No.
1, pp. 197
SLINGTAPE
Delmas V., Hermieu J., Dompeyre Boccon-Gibod L.
URATAPE:
ANATOMICAL
P., Messas A., Dumonceau
0.. Ravcry V.,
778 SEVERE COMPLICATIONS VAGINAL TAPE PROCEDURES Klingler
INTRODUCTION & OBJECTIVES: UraTape is a new minimal invasive treatment for stress urinary incontinence: its original route is transversal through the obturator foramcn. The aim of this study was to search the anatomical dangers of this new transobturator route. MATERIAL & METHODS: 10 female anatomical subjects not embalmed, 74 to 89 old. UraTape was placed with some variations on the level of entrance of the tunneler. Dissection by femoral, perineal or pelvic approach was led to study the anatomical structures possibly injured. RESULTS: Femoral dissection: after crossing the adductor muscles, there are no vessels or nerves at the inferior brim of the obturator foramen. The tape passes at the opposite side of the obturator canal, 4 cm under it. Perineal dissection: The tape is on the space between the perineal membrane and the inferior aspect of the levator ani muscle above the pudendal pedicle in the pudendal canal which is protected by the ischio pubic ramus. Pelvic dissection: The tape is crossing behind the Santorini plexus. When the tunneler is placed more anterior there is a danger for the anterior aspect of the bladder. When the tunneler is placed more posterior, perforation of the vagina is possible as bladder perforation. dONCLUSIONS: The route of UraTape is perineal. There is no risk to injury major vessels or nerves. But vaginal, vesical or urethral injury is possible. To avoid this risk a large lateral dissection has to be performed introduction of the index finger. The index will lead the tunneler’s
allowing
the
tip.
TENSION-FREE-
H., Tinzl C., Marberger J.
Universitiy
Bichat Hospital, Urology, Paris, France
FOLLOWING
of Vienna. Urology, Vienna, Austria
INTRODUCTION & OBJECTIVES: Tension-tree vaginal tapes are used for treatment of stress urinary incontinence. Serious adverse events are believed to be uncommon, as reported in the literature. However, in case of appearance complications may be severe and require immediate invasive intervention. MATERIAL & METHODS: Between 112001 and 812002 6 patients were referred to our institution because of serious adverse events for further consultation. another TVT procedure was performed at this institution. In 617 patients TVT procedure was performed by experts, only one procedure was performed by a beginner. According to the surgical reports, all recommended
safety guidelines were applied and intraoperative findings were uneventful in all patients. 3 procedures were performed under local andesthesia, one with spinal and 3 under general anaesthesia. RESULTS: Severe complications compromised significant haemorrhage (2), tape arosion (I) or dislocation (2) and obstruction (2). Severe haemorrhage required polytransfusion (> 6 blood units), both were hemodynamically unstable and required open surgical revision. Cause of bleeding was venous (I) and arterial bleeding (1) respectively. In both cases the TVT sling was removed and a Burch procedure was performed after local hemostyptic compression and thermal coagulation of the bleeding site. Tape arosion requiring TVT removal and urethral reconstruction. Proximal tape dislocation resulted in obstructive voiding. Surgical intervention with removal of TVT and simultaneous ureterolysis and facial sling correction was performed. One patient with urodynamically proven over-correction is on chronic intermittent catheterisation, despite TVT dissection and urethrolysis. One patient is on intermittent catheterisation due to incomplete bladder emptying, incontinence is still ongoing. CONCLUSIONS: TVT procedures may result in serious adverse events. even in the hand of experts and patients need to be counselled accordingly prior to surgery.
780
779 TRANS-OBTURATOR URETHRAL SUPPORT FOR FEMALE STRESS URINARY INCONTINENCE: 1 YEAR OUTCOME OF A NEW SURGICAI.
COMPETITIVE DARIFENACIN
AND REVERSIBLE INTERACTION WITH HUMAN RECOMBINANT M3 RECEPTORS
PROCEDURE Nuaplcr c‘.. Laakcy P., (iuota
Drouov
OF
S I. De Tayrac R ‘. Dclormc
Ptirer Inc. Discovery ‘CHU Bicetre, Urology, Le Kremhn B&tre, Gynaecology. Clamart. France. ‘Clinic. Urology. INTRODUCTION minimally invasive
& OBJECTIVES: surgical technique
approach
I’.. Clarke N.P.
1; France, ‘Hopital Antoine C‘halon sur Saone, France
We report the feasibility
and results of a new
using a vaginal tape inserted via a transto recreate a mid-urethral backboard for the
obturator
per-cutaneous
treatment
of stress urinary incontinence.
Biology,
Sandwich,
Umted Kingdom
B&l&.
MATERIAL & METHODS: UraTapc% (Porg&Mentor) is a non elastic polypropylene tape, with a silicone coated central part. The tape is placed without any tension under the mid-urethra and extended through the obturator foramen. It reproduces the natural suspension fascia ofthe urethra while preserving the retropubic space. No cystoscopy is required for the procedure. From May 2000 to February 2002. 32 consecutive patients with stress urinary incontinence associated with urethral mobility and without gemtal prolapse were operated. Mean age was 64 years (50-81). All diagnostics were assessed by an urodynamic testing. Four patients had intrinsic sphincter deficiency (~20 cmH,O). Fice patients had recurrent stress mcontinence after Burch or TVT procedures. Urge incontinence was associated in 18132 patients. Quality of life (QoL) assessment was carried out prc and postoperatively. All patients were evaluated for follow up by two independent surgeons: clinical examination, cough stress test, uroflowmcny. Objective and subjective criteria of voiding dysfunction were analysed: Qmaxc I Smlis, residual volume >20%, clinical dysuna, de nova urgencies or recurrent urinary Infections. RESULTS: Mean operative time was 1.5 minutes. No intra-operative complications were observed. Mean follow-up was 12 months (3-23). 27132 patients were completely cured (84.4%) and 5132 patients were significantly improved (I 5.6%). 28132 patients (87,.50/o) expressed good QoL (satisfied /very satisfied). One patient had a regressive postoperative urinary retention. There was no urethral erosion. One vaginal erosion was diagnosed at the time of follow up (23 months after the operation). 3132 patients (9.5 %) presented both objective and subjective criteria of voiding dysfunction. No sexual discomfort was reported.
INTRODUCTION & OBJECTIVES: In the USA. overactive bladder (OAB) with Incontinence has an estimated prevalence of l7?,0 (1). OAB results in social, psychological. sexual. behavioural and financial burden for the patient so effective treatment regimens arc Important. The muscarinic M3 receptor mediates contractile responses to acetylcholine in the bladder and may therefore be a target for the treatment of OAB. The aims of this study were to determine, using radioligand binding techniques, whether darifenacin is a competitive and reversible antagonist at the human recombinant M3 receptor and to compare the binding properties of darifcnacin wnh those of other muscarinic antagonists. MATERIAL & METHODS: These studies were performed using membrane homogenates of Chinese Hamster Ovary cells expressing recombinant human M3 receptors. The effects of the test antagonists on the binding parameters KD and Bmax were determined for [3H]-N-methyl scopolamine ([3H]-NMS) from a 12.point saturation analysis. Non-specific binding was determined using atropine. Using [3H]darifenacm, the rate of association and dissociation from the M3 receptor was also dctermmcd. Data were analyscd using the curve-fitting programs in GraphPad Prism. RESUUI‘S: Darifcnacin (l-10 nM), atropme (0.3-3 nM), tolterodine (l-100 nM) and oxybutynin (l-100 nM) all produced dose-dependent rightward shifts of the [3H]NMS saturation bmding curves without significantly altering the Bmax value (p>O.O5). This indicates that, at the concentrations tested, these compounds bind to the M3 receptor in a competitive manner. In contrast, Bmax values in the presence of 4DAMP mustard (I-IO nM) were significantly reduced (p
CONCLUSIONS: CONCLUSIONS: This proccdurc IS an effective promising new technique for the treatment of female stress urinary incontinence. The trans-obturator approach is safe. avoiding bladder. intestinal or vascular injuries and urinary retention. Further followup is necessary.
These data support findings of previous studies, which have shown that darifenacin has high affinity for the M3 receptor. In addition. these data mdicatc that darifenacin binds to the human recombinant M3 receptor in a competitive and reversible manner, providing further support for its use for the treatment of DAB. I. Milsom I. et al. BJU Int 2001; X7(9): 760-6.
European
Urology
Supplements
2 (2003) No.
1, pp. 197