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1522 LARGE VOLUME PAD WEIGHT IS PREDICTIVE OF FAILURE IN TREATING POST PROSTATECTOMY INCONTINENCE WITH THE ADVANCE SLING
Vol. 183, No. 4, Supplement, Tuesday, June 1, 2010
RESULTS: Sixty-three women (16%) were eligible but did not complete F/U⬎⫽12 months, leaving 326 women for reporting. Mean F/U for the entire cohort was 32.5 months. Group 1 (medium-term F/U) and Group 2 (long-term F/U) consisted of 285 and 41 women, respectively. Demographic and preoperative variables, and the incidence of previous pelvic surgery, were not significantly different (NS) between the two groups. SUI-cure rate was 88.4% and 78% in Groups 1 and 2, respectively (NS). Global-cure rate was 72.3% and 56.1% in Groups 1 and 2 respectively (p⬍0.05). A statistically significant improvement in SEAPI scores, QOL indices, and daily pad use was observed for both groups. Rates of short-term (⬍30 days) and long-term (⬎30 days) complications were similar between the two groups (NS). Reoperation rates were likewise similar (NS). CONCLUSIONS: At long-term F/U, the TO sling provides durable results in resolving SUI; however, the global-cure rate decreases significantly with longer periods of F/U. This suggests that factors other than SUI may play a more prominent role in determining long-term surgical outcomes in these women. The complication rates are low and, regardless of F/U length, women experience a significant improvement in their QOL. Source of Funding: None
1522 LARGE VOLUME PAD WEIGHT IS PREDICTIVE OF FAILURE IN TREATING POST PROSTATECTOMY INCONTINENCE WITH THE ADVANCE SLING Kristy Borawski*, Durham, NC; Daniel Rapoport, Vancouver, Canada; George Webster, Durham, NC INTRODUCTION AND OBJECTIVES: Appropriate patient selection is important in determining outcomes in treating post prostatectomy incontinence with the Advance sling. We reviewed our database of men treated with the Advance sling to see what factors were predictive of failure. METHODS: We retrospectively reviewed the records of 181 men who underwent placement of an Advance sling from January 2006 – September 2009. Pre-operative radiation, incontinence parameters, sphincter appearance and urodynamic data were reviewed. Primary outcomes were success, defined as significant improvement requiring only 1 pad for protection for stress incontinence with major activities, and continence, defined as the absence of incontinent episodes without the need for pads. RESULTS: Of the 181 men, 180 had a prostatectomy (59 robotic), 1 had a greenlight laser prostatic resection while 11 had prior radiation. The average age was 65 with a mean follow-up of 5 months. The mean pre-operative pad weight (PPW) was 331 grams (range 12-1133 grams) with 20% of the men with a pre-operative pad weight of ⬎500grams. Overall, 73.5% (133/181) were successful, while 57.5% (104/181) were continent. Of those who were not continent, 69% had a ⬎50% improvement in their 24 hour pad weight Multivariable logistic regression was then used to determine factors associated with failure. Subjects with a PPW ⬎500 grams were 7.3 (95% CI 2.8 – 19.0) and 4.1 (95% CI 1.7 – 9.8) times respectively more likely to be unsuccessful and incontinent compared to subjects with pad weight ⬍200 grams. Although it appeared as if the presence of poor volitional copaton of the sphincter was predictive of failure (success, OR 1.76 [95% CI 0.59 – 5.3, p⫽0.3)] continence OR 2.44 [95% CI 0.85 – 7.0, p⫽0.09] it did not achieve significance. Additionally, the absence of a scarred sphincter appeared to be protective and associated with better continence and success rates (success OR 0.5 [95% CI 0.17 – 1.5, p⫽0.2]; continent OR 0.37 [95% CI 0.13 – 1.09, p⫽0.07] however it did not reach significance. When looking at our “ideal candidate,” one with an intact sphincter (no scars, clefts) that is closed at rest who can volitionally contract the sphincter and no radiation exposure, those subjects had an 89% success rate and a 74% continence rate.
THE JOURNAL OF UROLOGY姞
e587
CONCLUSIONS: The Advance sling remains an option in treating post prostatectomy urinary incontinence. Higher PPW, the inability to volitionally coapt the sphincter and the presence of a scarred sphincter are associated with decreased cure rates. Source of Funding: None
1523 THERAPY OF REFRACTORY POSTOPERATIVE URINARY STRESS INCONTINENCE BY THE USE OF AUTOLOGOUS SKELETAL MUSCLE-DERIVED CELLS (MDC) Christoph Eimer*, Holger Gerullis, Roman Karig, Peter Goretzki, Neuss, Germany; Albert Ramon, Bad Aachen, Germany; Thomas Otto, Neuss, Germany INTRODUCTION AND OBJECTIVES: Urinary stress incontinence (USI) caused by morphological injury of the external urethral sphincter is refractory to conservative treatment. According to §4a of the German Pharmaceutical Law (AMG) we treated patients suffering from postoperative refractory grade III USI by transplantation of MDC. Patients were sent to our clinic from all parts of Germany. METHODS: In general or local anaesthesia muscle tissue is extracted from the deltoid muscle (sample size 5x5mm, 2 samples/ patient). The muscle tissue is converted into a primary cell culture separating individual cells and expanding them. Prior to the transplantation MDC are stored in physiological soda solution. Under visual guidance the cells are endoscopically injected into/around the lesion of the sphincter. RESULTS: 222 men aged 70 years (56-81) from 32 different hospitals in Germany were included. 60% (132/222) of the patients were followed-up for at least 12 months after MDC transplantation- the time span necessary for sufficient evaluation of the transplantation process. The average time since iatrogenic sphincter injury was 43 months (12-192). After a medium of 59 days (16-122) following the muscle biopsy transplantation of MDC was performed. 11.18x106 (0.21-29.23x106) of MDC are transplanted. 11,3 % (9.5-13.1%) of these cells are identified immunocytochemically as satellite cells (positive for MyoD1, ␣-sarcomeric actin, ␣-smooth-muscle actin). Reversible AE⬘s grade I were observed in 11% of the patients (15/132). After a minimum follow-up of 12 months (12-61) 18 patients (13.6%) were completely continent, 51 patients (38,6%) showed improvement from grade III USI to grade I (less than 100ml/24h uncontrolled urine loss). The treatment effect can be observed 4,7 months (2-9) after transplantation of MDC and remains stable during follow-up. 63/132 (48%) patients have no change regarding grade III incontinence. Control cystoscopy showed a morphologically intact external sphincter in 15% (20/63) of the patients despite lacking improvement of USI. CONCLUSIONS: Transplantation of MDC for the repair of iatrogenic damage of the external urinary sphincter and consecutive grade III USI is a safe procedure. In 52% (69/132) of the patients this method is efficient in distinctively reducing incontinence or even healing it. Disadvantages are the expenditure of time between treatment and efficacy of about 7 months, the cost situation, and the legal restrictions prohibiting us the initiation of GCP- conform clinical trials. Source of Funding: None
1524 AUTOLOGOUS MUSCLE-DERIVED CELLS AS THERAPY FOR STRESS URINARY INCONTINENCE: A RANDOMIZED, DOSE-RANGING TRIAL Lesley Carr*, Sender Herschorn, Toronto, Canada; Colin Birch, Magnus Murphy, Magali Robert, Calgary, Canada; Ronald Jankowski, Ryan Pruchnic, David Wagner, Pittsburgh, PA; Michael Chancellor, Royal Oak, MI INTRODUCTION AND OBJECTIVES: This is an updated report of a pilot study designed to evaluate the 12-month safety and preliminary effectiveness of autologous muscle-derived cell (AMDC) injection for the treatment of stress urinary incontinence (SUI).
RESULTS: Sixty-three women (16%) were eligible but did not complete F/U⬎⫽12 months, leaving 326 women for reporting. Mean F/U for the entire cohort was 32.5 months. Group 1 (medium-term F/U) and Group 2 (long-term F/U) consisted of 285 and 41 women, respectively. Demographic and preoperative variables, and the incidence of previous pelvic surgery, were not significantly different (NS) between the two groups. SUI-cure rate was 88.4% and 78% in Groups 1 and 2, respectively (NS). Global-cure rate was 72.3% and 56.1% in Groups 1 and 2 respectively (p⬍0.05). A statistically significant improvement in SEAPI scores, QOL indices, and daily pad use was observed for both groups. Rates of short-term (⬍30 days) and long-term (⬎30 days) complications were similar between the two groups (NS). Reoperation rates were likewise similar (NS). CONCLUSIONS: At long-term F/U, the TO sling provides durable results in resolving SUI; however, the global-cure rate decreases significantly with longer periods of F/U. This suggests that factors other than SUI may play a more prominent role in determining long-term surgical outcomes in these women. The complication rates are low and, regardless of F/U length, women experience a significant improvement in their QOL. Source of Funding: None
1522 LARGE VOLUME PAD WEIGHT IS PREDICTIVE OF FAILURE IN TREATING POST PROSTATECTOMY INCONTINENCE WITH THE ADVANCE SLING Kristy Borawski*, Durham, NC; Daniel Rapoport, Vancouver, Canada; George Webster, Durham, NC INTRODUCTION AND OBJECTIVES: Appropriate patient selection is important in determining outcomes in treating post prostatectomy incontinence with the Advance sling. We reviewed our database of men treated with the Advance sling to see what factors were predictive of failure. METHODS: We retrospectively reviewed the records of 181 men who underwent placement of an Advance sling from January 2006 – September 2009. Pre-operative radiation, incontinence parameters, sphincter appearance and urodynamic data were reviewed. Primary outcomes were success, defined as significant improvement requiring only 1 pad for protection for stress incontinence with major activities, and continence, defined as the absence of incontinent episodes without the need for pads. RESULTS: Of the 181 men, 180 had a prostatectomy (59 robotic), 1 had a greenlight laser prostatic resection while 11 had prior radiation. The average age was 65 with a mean follow-up of 5 months. The mean pre-operative pad weight (PPW) was 331 grams (range 12-1133 grams) with 20% of the men with a pre-operative pad weight of ⬎500grams. Overall, 73.5% (133/181) were successful, while 57.5% (104/181) were continent. Of those who were not continent, 69% had a ⬎50% improvement in their 24 hour pad weight Multivariable logistic regression was then used to determine factors associated with failure. Subjects with a PPW ⬎500 grams were 7.3 (95% CI 2.8 – 19.0) and 4.1 (95% CI 1.7 – 9.8) times respectively more likely to be unsuccessful and incontinent compared to subjects with pad weight ⬍200 grams. Although it appeared as if the presence of poor volitional copaton of the sphincter was predictive of failure (success, OR 1.76 [95% CI 0.59 – 5.3, p⫽0.3)] continence OR 2.44 [95% CI 0.85 – 7.0, p⫽0.09] it did not achieve significance. Additionally, the absence of a scarred sphincter appeared to be protective and associated with better continence and success rates (success OR 0.5 [95% CI 0.17 – 1.5, p⫽0.2]; continent OR 0.37 [95% CI 0.13 – 1.09, p⫽0.07] however it did not reach significance. When looking at our “ideal candidate,” one with an intact sphincter (no scars, clefts) that is closed at rest who can volitionally contract the sphincter and no radiation exposure, those subjects had an 89% success rate and a 74% continence rate.
THE JOURNAL OF UROLOGY姞
e587
CONCLUSIONS: The Advance sling remains an option in treating post prostatectomy urinary incontinence. Higher PPW, the inability to volitionally coapt the sphincter and the presence of a scarred sphincter are associated with decreased cure rates. Source of Funding: None
1523 THERAPY OF REFRACTORY POSTOPERATIVE URINARY STRESS INCONTINENCE BY THE USE OF AUTOLOGOUS SKELETAL MUSCLE-DERIVED CELLS (MDC) Christoph Eimer*, Holger Gerullis, Roman Karig, Peter Goretzki, Neuss, Germany; Albert Ramon, Bad Aachen, Germany; Thomas Otto, Neuss, Germany INTRODUCTION AND OBJECTIVES: Urinary stress incontinence (USI) caused by morphological injury of the external urethral sphincter is refractory to conservative treatment. According to §4a of the German Pharmaceutical Law (AMG) we treated patients suffering from postoperative refractory grade III USI by transplantation of MDC. Patients were sent to our clinic from all parts of Germany. METHODS: In general or local anaesthesia muscle tissue is extracted from the deltoid muscle (sample size 5x5mm, 2 samples/ patient). The muscle tissue is converted into a primary cell culture separating individual cells and expanding them. Prior to the transplantation MDC are stored in physiological soda solution. Under visual guidance the cells are endoscopically injected into/around the lesion of the sphincter. RESULTS: 222 men aged 70 years (56-81) from 32 different hospitals in Germany were included. 60% (132/222) of the patients were followed-up for at least 12 months after MDC transplantation- the time span necessary for sufficient evaluation of the transplantation process. The average time since iatrogenic sphincter injury was 43 months (12-192). After a medium of 59 days (16-122) following the muscle biopsy transplantation of MDC was performed. 11.18x106 (0.21-29.23x106) of MDC are transplanted. 11,3 % (9.5-13.1%) of these cells are identified immunocytochemically as satellite cells (positive for MyoD1, ␣-sarcomeric actin, ␣-smooth-muscle actin). Reversible AE⬘s grade I were observed in 11% of the patients (15/132). After a minimum follow-up of 12 months (12-61) 18 patients (13.6%) were completely continent, 51 patients (38,6%) showed improvement from grade III USI to grade I (less than 100ml/24h uncontrolled urine loss). The treatment effect can be observed 4,7 months (2-9) after transplantation of MDC and remains stable during follow-up. 63/132 (48%) patients have no change regarding grade III incontinence. Control cystoscopy showed a morphologically intact external sphincter in 15% (20/63) of the patients despite lacking improvement of USI. CONCLUSIONS: Transplantation of MDC for the repair of iatrogenic damage of the external urinary sphincter and consecutive grade III USI is a safe procedure. In 52% (69/132) of the patients this method is efficient in distinctively reducing incontinence or even healing it. Disadvantages are the expenditure of time between treatment and efficacy of about 7 months, the cost situation, and the legal restrictions prohibiting us the initiation of GCP- conform clinical trials. Source of Funding: None
1524 AUTOLOGOUS MUSCLE-DERIVED CELLS AS THERAPY FOR STRESS URINARY INCONTINENCE: A RANDOMIZED, DOSE-RANGING TRIAL Lesley Carr*, Sender Herschorn, Toronto, Canada; Colin Birch, Magnus Murphy, Magali Robert, Calgary, Canada; Ronald Jankowski, Ryan Pruchnic, David Wagner, Pittsburgh, PA; Michael Chancellor, Royal Oak, MI INTRODUCTION AND OBJECTIVES: This is an updated report of a pilot study designed to evaluate the 12-month safety and preliminary effectiveness of autologous muscle-derived cell (AMDC) injection for the treatment of stress urinary incontinence (SUI).