The Clinical Efficacy Study Of Intradetrusor Injection Of BTX-A Plus Hydrodistention To Treat Interstitial Cystitis/Bladder Pain Syndrome

Objective:To evaluate the efficacy and safety of intravesical botulinum toxin A injections for interstitial cystitis/bladder pain syndrome?IC/BPS?via meta-analysis.We collect the clinical datas of IC/BPS patients treated by hydrodistention or intradetrusor injection of BTX-A plus hydrodistention to further verify and evaluate the the efficacy and safety of BTX-A.Meanwhile,we also investigate the influence of different injection sites of BTX-A on the therapeutic effect.Methods The First Part:We conducted a comprehensive search of Pubmed,Embase,Web of Science database et al,and carried on a systematic review and meta-analysis of the published literature concentrated on botulinum toxin A injections for IC/BPS.The Second Part:69 consecutive BPS/IC patients from October 2011 to November2016 were divided into three groups according to surgical methods:group A?group B and group C.The patients were consisted of 5 males and 64 females,with age from23 to 66 years old,mean age was 44.5 years old.23 Patients?there were 1 male and22 females,with age from 23 to 69 years old,mean age was 44.6 years old?in control group?group A?were given treatment of hydrodistention.24 patients?there were 2 males and 22 females,with age from 27 to 65 years old,mean age was 42.8years old?in group B were given BTX-A detrusor combined triangle injection plus hydrodistention.22 patients?there were 2 males and 20 females,with age from 30 to68 years old,mean age was 44.3 years old?in group C were given BTX-A triangle injection alone plus hydrodistention.We compare the parameters such as daytime frequency,nocturia,VAS?visual analogue scale/score?,FCV?functional cystemetric volume?,PVR?post-void residual volume?QOL score,MBC?maximal bladder capacity?,ICSI?interstitial cystitis symtom index?,ICPI?interstitial cystitisproblem index?,Q_max,and HAMA?Hamilton anxiey scale?score between pretherapy and 1,3,6 and 9 months after therapy in three groups.Results The First Part:Five randomized controlled trials?RCTs?were enrolled based on the exclusion and inclusion criteria.In total,243 IC/BPS patients were enrolled in these studies,of which 143 patients were treated with intravesical botulinum toxin A injections?BTX-A group?,and the others were set as control group.Meta analyses showed that patients in BTX-A group suffered milder pelvic pain?standardized mean difference,SMD=-0.59;95%confidence intervals,95%CI:-0.92,-0.25;P=0.001?,Interstitial Cystitis Problem Index?ICPI?scores?SMD=-0.51;95%CI:-0.80,-0.23;P=0.000?,and Interstitial Cystitis Symptom Index?ICSI?scores?SMD=-0.39;95%CI:-0.67,-0.11;P=0.007?,and significant difference in daytime frequency of urination?SMD=-0.72;95%CI:-1.40,-0.05;P=0.037?,maximum cystometric capacity?MCC??SMD=0.63,95%CI:0.34,0.91;P=0.000?.However,there was no evident difference in nocturia?SMD=-0.52,95%CI:-1.22,0.18;P=0.147?,maximal urinary flow rate?Qmax??SMD=0.13;95%CI:-0.24,0.50;P=0.483?between BTX-A group and control group.Moreover,meta-analyses suggested that patients in BTX-A group were associated with a slightly larger volume of post void urine?PVR??SMD=0.36;95%CI:0.03,0.69;P=0.030?,nevertheless,the other adverse events such as dysuria and urine tract infection?UTI?were not statistically different between the two groups.The Second Part:There were no serious complications observed among three groups.All parameters 1 month after therapy were obviously superior to pretherapy.The efficacy in control group decreased significantly 3 months after treatment except nocturia?3.0 vs.5.0?,daytime frequency?7.0 vs.14.0?and Q_max?14.0 vs.13.0?than at admission.However,all parameters in research groups except PVR were still obviously superior to pretherapy.The parameters except PVR and nocturia in group B had statistically significant difference from contemporaneous group A?all P<0.05?.However,The parameters except PVR,nocturia and somatic anxiety score in group C had statistically significant difference from contemporaneous group A?all P<0.05?.VAS?2.0 vs.3.0?and somatic anxiety score?6.0 vs.10.0?in group B were superior to group C?all P<0.05?.When it came to 6 months after therapy,urinary frequence and urgency and pain symptoms were the same to prethrepy and all parameters had no statistically significant difference between pretherapy and after therapy in group A?all P>0.05?.But all parameters except PVR in research group was still superior to pretherapy.The parameters except PVR,Q_max and QOL in group B had statistically significant difference from contemporaneous group A?all P<0.05?.However,The parameters except PVR,Q_max,MBC,ICSI and QOL in group C had statistically significant difference from contemporaneous group A?all P<0.05?.Meanwhile,efficacy in group B was better than group C in ICPI?6.0 vs.8.0?and somatic anxiety score?7.0 vs.10.0??all P<0.05?.The efficacy decreased significantly 9 months after treatment both in group B and C,there was no statistically significant difference from pretherapy;ICSI?10.0 vs.13.0?,ICPI?9.0 vs.13.0?,QOL?5.0 vs.6.0?in group B,QOL?5.0 vs.6.0?in group C had statistically significant difference from contemporaneous group A.Group B was better in ICSI?10.0 vs.12.0?,MBC?285.0vs.237.5?than group C?all P<0.05?.Conclusions:Intravesical BTX-A injections plus hydrodistention have some efficacy in the improvement of bladder/pelvic pain symptoms,urination frequency,and cystometric capacity for the patients with IC/BPS,Quality of live can be improved remarkably and HAMA scroes can be reduced significantly after treatment,detrusor combined triangle injection may provide a better effect than single triangle injection,and without major complications occurred during the process.Therefore,BTX-A injections plus hydrodistention is an effective therapuic method for IC/BPS,and it is worthy of being generalized and further investigated in clinic.