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1, My involvementwith the trial: Dr. Tuite』s team went to China in 2009, and personally checkedmore than a dozen myelomeningocele and lipomyelomeningocele children who werecured by Xiao procedure 2~3 years ago, voiding voluntarily and emptying almostcompletely without incontinence. They then invited me to All Children』sHospital to help them to start Xiao procedure two days before my keynote speakon the first international spina bifida conference in Orlando, 2009. Theyscheduled 2 cases in 2 ORs on same time. I observed and helped in identifying correctroots, then they stopped and I was informed first time they were doing 「randomized,double blind trial」. I immediately expressed my strong objection based on tworeasons: First, Xiao procedure had been proved to be a very effective procedureby many centers with thousand cases and formal publications [123] includingthose in USA: Beaumont Hospital,NYU medical center, and Louisiana State University[456]. It is unnecessary and unethical to have a double blind trial on a majorsurgery on children, especially these disabled children. Second, it is impossible scientifically andtechnically to have a double blind trail for a very complicated major surgeryon spina bifida children whose history, anatomy, neural defect，bladder situation and voiding management may be quitedifferent for each other. The major technical dilemma was that children who hadXiao procedure have to stop CIC and anticholinergics 3 month postoperatively,to allow regenerated axons working with bladder and urethra, while children did not have Xiao procedureshould still keep using CIC and anticholinergics as guideline indicated toprotect the upper urinary system. How could you manage this dilemma in adouble-blind trial for 3 years?
Despite of mystrong objection, Dr. Tuite』s team decided to go on the double blind trial. I immediatelywithdrew my involvement in the 「double blind」 trial forever at the very firstday. So, I did not personally help the first 7 cases, but only 2 in the firstday. I had to tell with sorry that Ifound the donor ventral root was cut wrongly and closely form the cord at oneof the 2 cases, and the root had to be reattached to cord by microanastomosisand then its distal end was anastomosed to S3 root as Xiao procedure did. Ifthis kind of accident happened, the patient should be excluded from any type oftrials, since the root reattached to cord may not work at all and jeopardizethe down stair Xiao procedure. But I found the child was still listed as #5 (DT+X)in the article.
2,The trial andthe article have no creditability and value in terms of methodology, science, andstatistics. Randomized, double blind study requests strictest methodology, andmost objective quantity and quality control. While in the Tuite』s trial, inaddition to using another result-variable surgery as control, and very small samplesize which can not meet statistical request, each subject』s preoperative lowerurinary tract condition, abnormal anatomy, neural defects and prior surgicalhistory was different from any others; each of the 4 neurosurgeons performedprocedure had different level and experience in surgical skills. But most horrible defect was that the postoperativecare was different among the enrolled children regarding anticholinergics andCIC. The authors tried to smooth up the defect by stated in the articletwice 「CIC and the use of BAMs were terminated 2 weeks prior to preoperativeevaluations, and most patientswere able to refrain from both of these modalities for the entire 3-yearfollow-up.」 This statement destroyedcompletely the scientific and methodological ground of this so called doubleblind study: Post care must be strictly the same, i.e., either all use CIC andsame dosage BAMs, or all do not use CIC and BAMs. How many was the 「most」, 11? 15? or 18?Authors did not report this critical and most important data. But nevertheless, it was fundamentally wrongto paralyze some patient bladder by BAMs while not to paralyze other』s inpostoperative follow-ups in a double blind trial, and then collect and analysistheir data together.
3, However, I don』tbelieve at all it was the truth that 「CIC and the use of BAMs were terminated 2weeks prior to preoperative evaluations, and most patients were able to refrain from both of thesemodalities for the entire 3year followup.」 With experience during the first USA pilot study of Xiao procedure inBeaumont hospital, I know how hard and difficult in trying to convince Peters』 teamand local primary care doctors to stop anticholinergics and CIC for spinabifida children underwent Xiao procedure. I would just post the emails below toshow how desperate when I tried to ask them to follow my way. Fortunately, theyreluctantly agreed and then, got the expected good results.
>>> "Xiao, Chuan-Guo" <Chuan-Guo.Xiao@nyumc.org>2/13/2009 6:44 AM >>>
Ken，
I have been thinking about the cases in Beaumont, The results as you mentionedare really not good to me..Before I talk about the possible causes, I want totell you how I deal with Kelly, the Louisana girl. I remote controlled all hertreatment after the surgery.
1, Stopped detropen exactly 2 months after surgery.(She wasoperated on Oct. 8, 2008.) Wear diaper, DON'T care leaking or not.
2 ,Stopped regular catherterization since the 3 months aftersurgery(Jan.8.2009), Just once before going to bed. Then, she got one mild UTIbut no change on catheraization. Ask the girl to try to void, by pushing orwhatever ways.
3, Now, it is just more than 4 months after surgery, sheseems to have got it.
In China,none of the patients has ever used Detropen before or after surgery; None ofthem has had any formal medical management of bladder and bowel, like regularcatherizaton or so on after the surgery. But, 80-86% of more than 1300 kidsgained continence and voluntary voiding.
So, my opinion is: You guys take care of these kids verygood,TOO GOOD to let the bladder and the new reflex and the brain to havechances to communicate with each other. You Doctors are always on controlinstead of allowing the brain to takeover the control. Why the bowel function improvementis better than bladder? Doctors did not take care of the bowel as good as thebladder.
Then, my suggestion is: immediately stop cathertrization onall the kids underwent the surgery, just ask them to try to void, and wear diaper! (especially Bill, the boy on the News.) Then let's see whatwill happen in a month before you go to Orlando.As I always say, spina bifida kids do not need to scratch the leg to initiatethe reflex for voiding, including Natasha. They should be able to voidvoluntarily.
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>>> "Xiao, Chuan-Guo" <Chuan-Guo.Xiao@nyumc.org>2/17/2009 10:43 PM >
Ken,
I am forwarding the email to you to support my point. If it were you, you mostpossibly would keep using Detropen and cathing her because she has a 200ccresidual. The fact is: the residual will decrease every day if we let the brainto take control.
So, please order those kids to stop Detropen and catherization. OK, mycompromise: you can let them cath once per day just before going to bed.
I would also quotefrom Denmark paper regardinganticholinergics in Xiao Procedure, to show how urologists deal withanticholinergics seriously in USAand Europe :
" Althoughthese criteria were first published after the current study began, most of themwere met in our series except the upper limit of bladder capacity and thecessation of anticholinergic medication. In regard to the latter we deemed thatthe medication was essential for patient well-being throughout the 18-monthstudy period.」 【9】
It seems to be thesimilar situation with Tuite』s trial patients: They were scatted over differentstates under care of their local primary care doctors who would not dare to notuse anticholinergics and CIC for 3 years. So I would suggest the authors, orthe editor of JNS, collect data from these children』s local doctors and providethe real fact regarding the post operative usage of CIC and anticholinergics in3 years. In fact, I did ask Dr. Tuite about this information last year duringthe only contact after my withdrew ,but he did not provide details in his response.
Hello,Jerry, and Yves:
I looked back and find thoseemails to Ken Peters when I tried very hard to convince him to stop CIC andDetropen in 2009.I hope I can convince you, too.
I am still having some concerns aboutthe anticholinergics. Did Yves take care of all those kids and did not useanticholinergics at all? If so, I really appreciate , because one of thereasons I argued against your double blind trial plan is that no Detropenshould be used for Xiao procedure kids, but need to be used routinely for thosecontrol kids. BUT, were there any kids under the care of their primarycare doctors who would definitely not stop using anticholinergics?
Any way, for the best interests ofmillions spina bifida kids, I really hope to clarify problems underlying yourtrial results. The effect of Xiao Procedure, at least in China includingmy hospital and other institutions in ShanghaiWuhan etc, has been veryreliable and better and better. I really feel sorry for your results.
Best regards,
CG Xiao_____________________________________________________________________________
4, The article,however, is not the end of this trial. I am confident to reverse the negativeresults to some degree. I put all my saving in and established a privatehospital in China.Of the 300 beds, 30 are for spina bifida and SCI patients with neurogenicbladder and bowel, and each such patient only pay 8,000USD (less or free for poorpeople) for all costs including surgery, anesthetic, OR hours, electrophysiologytest and in OR monitoring, urodynamic, presurgery tests, MRI and X ray, Ultrasound，pathology, exhaustible, medicines, ward for unlimitedin-hospital days and so on.
My suggestion is:
(1), Since it has been out of double-blind, please letthe 10 children who underwent Xiao procedure wear diaper and stopanticholinergics and let them try to void by push, leak or whatever means for 2months, then see what happen. Giving the neurosurgeons a 50% learning curvededuction, it should still have at least 3~4 children who will able to void voluntarilywithout incontinence and CIC. All spina bifida kidsafter Xiao procedure do not need scratch to pee. For 3000 kids whohad Xiao procedure, none of them needs bladder augmentation.
(2), In China, my hospital has an openpolicy regarding Xiao procedure patients: If the patient can not void voluntarilywithin one year (for child) or 18 month(for adult) post Xiao procedure, Prof.Xiao will redo the procedure himself for you free, no matter where and who didthe Xiao procedure. Now, I would like to extend this policy internationally. Iwill redo the Xiao Procedure free for all children failed in Tuite』s trial,including those served as control. The patients only need to take care of theirround trip air tickets between USAand Hong Kong airport. if I can not get about80% effective rates for those children within a year, or at least as good asPeters』 trial results[10], I will apologize formally in J Neurosurg Pediatr. It can be better than 80%, but I have tobe cautious due to they had had intradural neurosurgery at least 2 times on thesame location.
5, Is it legal andfinancially appropriate to bill Medicare, Medicaid or other Medical insurancesfor extra costs of Xiao procedure under the name of another surgery DT? This should also raise more ethical concern onthe real reason of this very hazardous double-blind study of a major surgery ondisabled children.
6, I appreciateDr. John R. W. Kestle』 s comments. It isobjective and helpful from an experienced surgeon. As for other issue, therewill be more appropriate platform to discuss than on the academic platform thatyour journal supposed to be.
Sincerely yours,
Chuan-Guo Xiao,M.D.
President
C.G. XIAO HOSPITAL
Shenzhen, China
Emai:cgxiao_hospital@163.com
References
1, Xiao CG, Du MX, Li B et al: An artificialsomatic-autonomic reflex pathway procedure for bladder control in children withspina bifida. J Urol 2005; 173: 2112.
2, Lin H, Hou C, Zhen X et al: Clinical study ofreconstructed bladder innervations below the level of spinal cord injury toproduce urination by Achilles tendon-to-bladder reflex contractions. JNeurosurg Spine 2009; 10: 452.
3, Lin H, Hou CL, Zhong G et al: Reconstructionof reflex pathways to the atonic bladder after conus medullaris injury:preliminary clinical results. Microsurgery 2008; 28: 429.
4. Lin H and Hou C: Transfer of normal S1 nerve rootto reinnervate atonic bladder due to conus medullaris injury. Muscle Nerve2013; 47: 241.
5, Kelley CE, Xiao CG, Weiner H et al: bladder inpatients with spinal cord injury: preliminary results of first 2 USA patients. JUrol, suppl., 2005; 173: 1132A.
6, Peters KM, Girdler B, Turzewski C et al:Outcomes of lumbar to sacral nerve rerouting for spina bifida. J Urol 2010;184: 702.
7, Peters K, Feber K, Girdler B et al:Three-year clinical outcomes with lumbar to sacral nerve rerouting in spinabifida. J Urol 2011; 185: e602.
8, Ravish Patwardhan, M. D. & John Mata,M.D. ( LSU): Case report on Xiao procedure for a 6 year old SCI girl to gainbladder control. Supplement of Firstinternational Neural Regeneration Conference, 2009 Detroit, USA
9, Rasmussen MM, Rawashdeh YF, Clemmensen D,Tankisi H, Fuglsang-Frederiksen A, Krogh K, et al: The artificial somato-autonomicreflex arch does not improve lower
urinary tract function in patients withspinal cord lesions. J Urol 193:598–604, 2015
10, Peters KM, Gilmer H, Feber K, Girdler BJ,Nantau W, Trock G, et al: US pilot study of lumbar to sacral nerve rerouting torestore voiding and bowel function in spina bifida: 3-year experience. Adv Urol2014:863209, 2014
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