21 December 2017

We need more info about BBS return and epidural stimulation

Hello everyone. I've spent the past weeks trying to craft together some questions about BBS (bladder, bowel, sexual function) return to ask to Dr Susan Harkema's team involved in epidural stimulation trials. My time was not only spent writing, but consulting with other activists in the community as I wanted to make sure that my questions were both correct and fair. 

As you may know, the trial, with many sponsors including CDRF (Christopher and Donna Reeve Foundation), and marketed under the BigIdea (which I think is wonderful marketing) has produced two papers and has put out some information about BBS return. 

See the last two posts for more information about the trials and my interest in them.

Below is the question I will be sending to Dr Harkema as I know there is a very big interest in the spinal cord injury community in the trials and especially in the claims of some BBS return. I think hearing directly from the scientist as opposed to the media will give us a better idea about what this trial will mean for us.
Thank you once again for your kind assistance. I actually had a few more questions, specifically about BBS.

I am happy to hear that the BBS study will be integrated, even if not completely, in the trial. As you know, time and time again, BBS return hits the top of the wish list for functional return.

Part I
I have been reading about other kinds of electrical stimulation and BBS and came across the Finetech-Brindley Bladder Control System which uses anterior sacral nerve stimulation. It seems that there have been very good results with this and another clinical trial is currently going on which will test it without the need for a rhizotomy. As you also aware, Medtronic IntrastimII also uses electrical stimulation to help BBS return.

Question 1:
If electrical stimulation has already been proven to affect BBS return, why was improvement in BBS so unexpected in the initial study of the four men and no preparation made to measure any return?

Is epidural stimulation and anterior sacral nerve stimulation so fundamentally different that a return was impossible to hypothesise?

Part II
I also have some comments and questions regarding the reporting of improvements in BBS. I understand that since the return was unexpected there was no measurements of the original four participants BBS prior to the trial to establish a baseline. Therefore, once the trial was completed, you couldn’t compare BBS before and after and thus didn’t include BBS return in either of the two papers published on the epidural stimulation trial in Louisville. 

But there has already been wide spread reporting on the BBS return. The reports range from “improvements” to “restored”.
The CRDF website reported on 9 October 2014 that, "Even more surprisingly, all four participants experienced significant improvements in autonomic functions, including bladder, bowel and sexual function, as well as temperature regulation."

On 10 April 2014, MobilityWorks reported that, “Rob Summers, showing the most advanced results, has had bowel, bladder and sexual function restored.” 

And CNN reported 2 January 2015 that, “The men, who all experienced varying levels of sexual dysfunction, say their sex lives returned to normal once the stimulators were implanted.

I know that these are not the words of the researchers, but of supporters and the news media. The problem is that since there has been no reporting directly from your team, we in the spinal cord injury community don’t know what to believe.

Question 2 (I think Dr Harkema might be best to answer this as the main investigator in the initial trial)
As I was told in the past emails, much of the BBS return study will be based on questionnaires, therefore wouldn’t it be possible to do a before and after questionnaire with the four original participants now?

Even if the questionnaire is not possible, would it be possible to explain in layman’s terms what was restored?

For example:
  • Do the men still need to need to catheterise themselves?
  • Do they know when their bladders and bowels are full?
  • Do they still need a specific bowel programme with the use of digital stimulation, laxatives, and/or suppositories?
  • Have they had any accidents with bladder and bowel since their trial ended?
  • Do they still need to use any medications to achieve and maintain erections?
  • Are psychogenic erections possible now?
  • Can they experience climax and/or ejaculation?

Answering these questions will help us in the community know more about BBS return and epidural stimulation as we all know that what’s reported in the media isn’t always very accurate when it comes to science. 

To be honest, many of those I am in contact with are sceptical of the current results regarding functional return in motor skills as it relates to their quality of life, but would be happy even if it only worked on BBS.

I wouldn’t even dare to ask you to answer these questions if the media weren’t already reporting on it. Actually, more importantly than the media, CDRF, one of the main sponsor is reporting that there is return. 

I therefore sincerely ask you to give the community more information on what return these four men experienced. If you feel that answering these questions in an email would be difficult, I would be truly happy to interview you directly.

I know we are entering the holiday season so I know you are very busy and I appreciate all your time in dealing with my questions. I have many readers who are excited by your work and want more information.

I wish you and yours a happy holiday season.

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