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PERIODIC INTRA-DETRUSOR INJECTIONS OF BOTULINUM NEUROTOXIN TYPE-A IN PATIENTS WITH INTRACTABLE DETRUSOR OVERACTIVITY
Vol. 179, No. 4, Supplement, Tuesday, May 20, 2008
395 :H XVH$129$ DQG %RQIHUURQL WHVW IRU VLJQL¿FDQW GLIIHUHQFH 6LJQL¿FDQFHZDVHVWDEOLVKHGDWS 8ULQDU\UHWHQWLRQZDVGH¿QHG as symptomatic PVR>200ml or any pt with PVR>300ml regardless of symptoms. Only symptomatic pts with pain or discomfort, inability to urinate, urinary tract infection or hydronephrosis on renal ultrasound were advised to start CIC. RESULTS: 44 pts with IOAB were injected. The Figure illustrates the number of BTX injections that pts have received with the PVR at each measured time point. 5 Pts (11%) needed to start CIC. Two pts who started CIC after the 1st BTX injection were able to stop by 16wks. These two pts subsequently withdrew from the study. The other 3 pts started CIC respectively after the 2nd, 3rd, and 4th BTX injection. None of these pts required CIC on subsequent injections. Two pts stop CIC before 12wks and the other at 20wks. Hydronephrosis was never found in these pts. 4/5 Pts who needed CIC received BTX 150 U and 1/5 received a 100 U. CONCLUSIONS: BTX injection increases PVR within 2 weeks. Not all patients with PVR>200ml will need to start CIC if there is no hydronephrosis, no urinary tract infection, and no discomfort, pain or inability to urinate. The need for CIC after the initial BTX injection does not necessarily imply that this therapy will be needed in subsequent injections. Figure. PVR in 6 BTX Repeated Injections
THE JOURNAL OF UROLOGY®
567
neurotoxin type-A. Re-injections were planned when the patients reported return of overactive bladder symptoms. All patients underwent pre-treatment urodynamics to determine detrusor overactivity before intra-detrusor injections. IDO patients received 200u whereas NDO patients 300u. Urogenital Distress Inventory (UDI 6) and Incontinence Impact Questionnaire (IIQ 7) were completed before each treatment and 4 weeks after treatment as a part of the study. All injections were SHUIRUPHGXQGHUORFDODQHVWKHVLDXVLQJDÀH[LEOHF\VWRVFRSH6WDWLVWLFDO analyses were performed using paired t test and non parametric test. RESULTS: There were 3 males & 14 females among the 17 patients of intractable detrusor overactivity. DO was idiopathic in 5 and due to neurogenic causes in 12. Neurogenic causes were PXOWLSOHVFOHURVLV $9PDOIRUPDWLRQV VSLQDEL¿GD WUHDWPHQW RI VXEDUDFKQRLG F\VW DQG VSDVWLF SDUDSDUHVLV 7KH¿UVWPHDQ interval was 12.2 months and the 2nd & 3rd periodic injections were administered after a mean interval of 13.3 & 12.5 months, respectively. The mean maximum cystometric capacity increased by 260 ml after the 1st injection and thereafter by 285, 215 & 260 mls after the 2nd, 3rd & 4thLQMHFWLRQVUHVSHFWLYHO\7KH8', ,,4VFRUHVVKRZVLJQL¿FDQW (p<0.05) improvement after treatment each time and the scores rise by the time the patients report for re-injections. The mean total UDI 6 & IIQ 7 score reduced from 15.5 to 6.1 after the 1st injection. Score was 24.08 before 2nd injection & in response to treatment reduced to 9.0. Similar trend was seen after the 3rd (20.3 to 7.5) and 4th (23.5 to 2.9) injections. &21&/86,216 7KHUHVXOWVUHYHDOWKDWWKHUHLVVLJQL¿FDQW improvement in clinical and urodynamic parameters after each periodic LQMHFWLRQ7KHUHLVQRHYLGHQFHRIUHVLVWDQFHDQGHI¿FDF\DSSHDUVWREH sustained as evident from the data. The time interval between periodic LQMHFWLRQVLVQRWVLJQL¿FDQW Source of Funding: Allergan provide botulinum neurotoxin type-A(Botox®) gratis for our patients and the MS Society of Great Britain and N Ireland.
1661
Source of Funding: Allergan provided study medication and some funding.
1660 PERIODIC INTRA-DETRUSOR INJECTIONS OF BOTULINUM NEUROTOXIN TYPE-A IN PATIENTS WITH INTRACTABLE DETRUSOR OVERACTIVITY Shahid Khan*, Apostolos Apostolidis, Gwen Gonzales, Sohier Elneil, Clare J Fowler, Prokar Dasgupta. London, United Kingdom. INTRODUCTION AND OBJECTIVE: 184 patients with intractable detrusor overactivity of neurogenic (NDO) and idiopathic (IDO) origin have been treated with intra-detrusor botulinum neurotoxin type-A under an open labelled programme. The objectives of this study are to show the changes in clinical and urodynamic parameters before and after at least 4 consecutive periodic injections. METHODS: 17 patients with intractable detrusor overactivity both idiopathic as well as neurogenic have undergone at least 4 consecutive periodic injections of intra-detrusor injections of botulinum
EFFECT OF REPEATED INTRADETRUSOR INJECTIONS OF BOTULINUM-A TOXIN ON BLADDER CAPACITY, DETRUSOR PRESSURE AND COMPLIANCE FOR TREATING PATIENTS WITH IDIOPATHIC DETRUSOR OVERACTIVITY Daniel M Schmid*, Sharmistha G Roy-Guggenbuehl, Tullio Sulser, Brigitte Schurch. Zurich, Switzerland. INTRODUCTION AND OBJECTIVE: Nonneurogenic urinary incontinence is partially due to OAB, which refers to the symptom complex of frequency, urgency and nocturia. OAB is related to a disorder of the storage phase of the bladder. Our former study in 200 SDWVKRZVWKDWD¿UVW%R17$LQMHFWLRQVLQFUHDVHGPD[LPXPF\VWRPHWULF capacity (MCC) and reduced clinical symptoms as urgency, frequency and incontinence. As we lacked knowledge of urodynamic effects of repeated injections, we evaluated in this study urodynamic parameters of consecutive BoNT-A injections in the detrusor muscle in patients with idiopathic OAB resistant to conventional treatment, who needed a VHFRQG%R17$WUHDWPHQWDIWHUORVVRIHI¿FDF\RIWKHLU¿UVWLQMHFWLRQ METHODS: Out of 55 pat. with repeated BoNT-A intradetrusor injections, 30 patients (25 women and 5 men) with relapsing symptoms of OAB underwent clinical checks and standard urodynamic studies EHIRUHDQGZHHNVDIWHUWKHLU¿UVWDQGVHFRQGLQMHFWLRQUHVSHFWLYHO\ We compared then the urodynamic parameters measured at baseline and after two consecutive injections of 100 U of BoNT-A. RESULTS: The interval between two subsequent treatments reached from min. 4 months to max. 26 months (mean 12 months). We REVHUYHG D VLJQL¿FDQW LQFUHDVH RI WKH 0&& DIWHU HYHU\ FRQVHFXWLYH injection, as the MCC rised from a mean baseline of 246 ml to 379 ml DIWHUWKH¿UVWLQMHFWLRQDQGWRPODIWHUWKHVHFRQGLQMHFWLRQ S 7KH HQG ¿OOLQJ GHWUXVRU SUHVVXUH VKRZV D VLJQL¿FDQW GHFUHDVH IURP EDVHOLQHFP+2WRDPHDQYDOXHRIFP+2 ¿UVWLQM DQGWKHQ to 23.2 cmH2O (second inj.) (p=0.0034). Bladder compliance improved from baseline 24 ml/cmH2O to 44.6 and 52.5 l/cmH2O (p=0.0001), respectively. All our patients reported reduced OAB symptoms after treatments, and comparing quality of life, we saw no significant GLIIHUHQFHVEHWZHHQD¿UVWDQGDFRQVHFXWLYHLQMHFWLRQ &21&/86,216 %HVLGHVWKHZHOONQRZQHI¿FDF\RI%R17$
395 :H XVH$129$ DQG %RQIHUURQL WHVW IRU VLJQL¿FDQW GLIIHUHQFH 6LJQL¿FDQFHZDVHVWDEOLVKHGDWS 8ULQDU\UHWHQWLRQZDVGH¿QHG as symptomatic PVR>200ml or any pt with PVR>300ml regardless of symptoms. Only symptomatic pts with pain or discomfort, inability to urinate, urinary tract infection or hydronephrosis on renal ultrasound were advised to start CIC. RESULTS: 44 pts with IOAB were injected. The Figure illustrates the number of BTX injections that pts have received with the PVR at each measured time point. 5 Pts (11%) needed to start CIC. Two pts who started CIC after the 1st BTX injection were able to stop by 16wks. These two pts subsequently withdrew from the study. The other 3 pts started CIC respectively after the 2nd, 3rd, and 4th BTX injection. None of these pts required CIC on subsequent injections. Two pts stop CIC before 12wks and the other at 20wks. Hydronephrosis was never found in these pts. 4/5 Pts who needed CIC received BTX 150 U and 1/5 received a 100 U. CONCLUSIONS: BTX injection increases PVR within 2 weeks. Not all patients with PVR>200ml will need to start CIC if there is no hydronephrosis, no urinary tract infection, and no discomfort, pain or inability to urinate. The need for CIC after the initial BTX injection does not necessarily imply that this therapy will be needed in subsequent injections. Figure. PVR in 6 BTX Repeated Injections
THE JOURNAL OF UROLOGY®
567
neurotoxin type-A. Re-injections were planned when the patients reported return of overactive bladder symptoms. All patients underwent pre-treatment urodynamics to determine detrusor overactivity before intra-detrusor injections. IDO patients received 200u whereas NDO patients 300u. Urogenital Distress Inventory (UDI 6) and Incontinence Impact Questionnaire (IIQ 7) were completed before each treatment and 4 weeks after treatment as a part of the study. All injections were SHUIRUPHGXQGHUORFDODQHVWKHVLDXVLQJDÀH[LEOHF\VWRVFRSH6WDWLVWLFDO analyses were performed using paired t test and non parametric test. RESULTS: There were 3 males & 14 females among the 17 patients of intractable detrusor overactivity. DO was idiopathic in 5 and due to neurogenic causes in 12. Neurogenic causes were PXOWLSOHVFOHURVLV $9PDOIRUPDWLRQV VSLQDEL¿GD WUHDWPHQW RI VXEDUDFKQRLG F\VW DQG VSDVWLF SDUDSDUHVLV 7KH¿UVWPHDQ interval was 12.2 months and the 2nd & 3rd periodic injections were administered after a mean interval of 13.3 & 12.5 months, respectively. The mean maximum cystometric capacity increased by 260 ml after the 1st injection and thereafter by 285, 215 & 260 mls after the 2nd, 3rd & 4thLQMHFWLRQVUHVSHFWLYHO\7KH8', ,,4VFRUHVVKRZVLJQL¿FDQW (p<0.05) improvement after treatment each time and the scores rise by the time the patients report for re-injections. The mean total UDI 6 & IIQ 7 score reduced from 15.5 to 6.1 after the 1st injection. Score was 24.08 before 2nd injection & in response to treatment reduced to 9.0. Similar trend was seen after the 3rd (20.3 to 7.5) and 4th (23.5 to 2.9) injections. &21&/86,216 7KHUHVXOWVUHYHDOWKDWWKHUHLVVLJQL¿FDQW improvement in clinical and urodynamic parameters after each periodic LQMHFWLRQ7KHUHLVQRHYLGHQFHRIUHVLVWDQFHDQGHI¿FDF\DSSHDUVWREH sustained as evident from the data. The time interval between periodic LQMHFWLRQVLVQRWVLJQL¿FDQW Source of Funding: Allergan provide botulinum neurotoxin type-A(Botox®) gratis for our patients and the MS Society of Great Britain and N Ireland.
1661
Source of Funding: Allergan provided study medication and some funding.
1660 PERIODIC INTRA-DETRUSOR INJECTIONS OF BOTULINUM NEUROTOXIN TYPE-A IN PATIENTS WITH INTRACTABLE DETRUSOR OVERACTIVITY Shahid Khan*, Apostolos Apostolidis, Gwen Gonzales, Sohier Elneil, Clare J Fowler, Prokar Dasgupta. London, United Kingdom. INTRODUCTION AND OBJECTIVE: 184 patients with intractable detrusor overactivity of neurogenic (NDO) and idiopathic (IDO) origin have been treated with intra-detrusor botulinum neurotoxin type-A under an open labelled programme. The objectives of this study are to show the changes in clinical and urodynamic parameters before and after at least 4 consecutive periodic injections. METHODS: 17 patients with intractable detrusor overactivity both idiopathic as well as neurogenic have undergone at least 4 consecutive periodic injections of intra-detrusor injections of botulinum
EFFECT OF REPEATED INTRADETRUSOR INJECTIONS OF BOTULINUM-A TOXIN ON BLADDER CAPACITY, DETRUSOR PRESSURE AND COMPLIANCE FOR TREATING PATIENTS WITH IDIOPATHIC DETRUSOR OVERACTIVITY Daniel M Schmid*, Sharmistha G Roy-Guggenbuehl, Tullio Sulser, Brigitte Schurch. Zurich, Switzerland. INTRODUCTION AND OBJECTIVE: Nonneurogenic urinary incontinence is partially due to OAB, which refers to the symptom complex of frequency, urgency and nocturia. OAB is related to a disorder of the storage phase of the bladder. Our former study in 200 SDWVKRZVWKDWD¿UVW%R17$LQMHFWLRQVLQFUHDVHGPD[LPXPF\VWRPHWULF capacity (MCC) and reduced clinical symptoms as urgency, frequency and incontinence. As we lacked knowledge of urodynamic effects of repeated injections, we evaluated in this study urodynamic parameters of consecutive BoNT-A injections in the detrusor muscle in patients with idiopathic OAB resistant to conventional treatment, who needed a VHFRQG%R17$WUHDWPHQWDIWHUORVVRIHI¿FDF\RIWKHLU¿UVWLQMHFWLRQ METHODS: Out of 55 pat. with repeated BoNT-A intradetrusor injections, 30 patients (25 women and 5 men) with relapsing symptoms of OAB underwent clinical checks and standard urodynamic studies EHIRUHDQGZHHNVDIWHUWKHLU¿UVWDQGVHFRQGLQMHFWLRQUHVSHFWLYHO\ We compared then the urodynamic parameters measured at baseline and after two consecutive injections of 100 U of BoNT-A. RESULTS: The interval between two subsequent treatments reached from min. 4 months to max. 26 months (mean 12 months). We REVHUYHG D VLJQL¿FDQW LQFUHDVH RI WKH 0&& DIWHU HYHU\ FRQVHFXWLYH injection, as the MCC rised from a mean baseline of 246 ml to 379 ml DIWHUWKH¿UVWLQMHFWLRQDQGWRPODIWHUWKHVHFRQGLQMHFWLRQ S 7KH HQG ¿OOLQJ GHWUXVRU SUHVVXUH VKRZV D VLJQL¿FDQW GHFUHDVH IURP EDVHOLQHFP+2WRDPHDQYDOXHRIFP+2 ¿UVWLQM DQGWKHQ to 23.2 cmH2O (second inj.) (p=0.0034). Bladder compliance improved from baseline 24 ml/cmH2O to 44.6 and 52.5 l/cmH2O (p=0.0001), respectively. All our patients reported reduced OAB symptoms after treatments, and comparing quality of life, we saw no significant GLIIHUHQFHVEHWZHHQD¿UVWDQGDFRQVHFXWLYHLQMHFWLRQ &21&/86,216 %HVLGHVWKHZHOONQRZQHI¿FDF\RI%R17$