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A pilot study evaluating spinal nerve re-routing to restore bladder and bowel function in children with spina bifida has generated some promising results that are a basis for undertaking a larger and more rigorous multicenter trial.
The pilot study included nine children who underwent lumbar to sacral nerve (S2 or S3) re-routing through a laminectomy. At 24 months of follow-up, bladder contraction could be initiated by stimulation of the appropriate dermatome in seven patients, proving the re-routing was successful. Eight patients were able to void some, five were emptying their bladder by more than half, and eight no longer needed antimuscarinic medications, although only two were able to discontinue intermittent catheterization. Urodynamic studies showed bladder capacity increased and compliance improved.
"We are now planning an NIH-sponsored multicenter trial to further investigate the safety and effectiveness of the re-routing procedure," said Dr. Dyche, chief urology resident at William Beaumont Hospital, working with Kenneth M. Peters, MD, and colleagues. "We want to stress that because of the potential risks, we feel strongly that it should be performed only in a clinical research protocol."
Data from 36 months of follow-up are being reviewed, and while the final analysis is not yet completed, it appears that the benefit of the surgery has not reached a plateau at 24 months. Dr. Dyche reported that at 3 years, four of the nine children are off catheterization and voiding. An additional four children have undergone the re-routing procedure, and at 9 months postoperatively, two were voiding and off catheterization.
The multicenter study will be conducted at William Beaumont Hospital and Emory University, Atlanta. In addition to enrolling more patients, its methods will include additional assessments to provide more robust data on anal and bladder sphincter function. However, there will be no changes in the surgery itself, which aims to reproduce the procedure performed by its innovator, Chuan-Guo Xiao, MD.
"If we change the procedure and the surgery is not successful, we'd be criticized for modifying the technique," said Dr. Peters, chairman of urology at William Beaumont Hospital.
"First, we need to prove there is a benefit using the same technique as Dr. Xiao, and then we believe there are many ways to refine the procedure that can make it better."
The multicenter study will exclude children who had undergone intrauterine closure of their myelomeningocele because the two children in the pilot study in whom the re-routing was not successful were among three children with this history.
"Children who had intrauterine surgery had significant scar tissue that made the re-routing surgery much more difficult," Dr. Peters told Urology Times.