Clinical Study b

After percutaneous placement of the balloon device, in-line expansion of the distal ureter was achieved on an outpatient basis over 23-38 days to a volume of upto 218 mL. Notably, all three patients did not require any analgesia during this entire expansion process.

Following our laboratory experiments and upon availability of the opportunity in two outside medical centers, we performed this procedure in three patients outside the United States, in India (N=2) and Brazil (N= 1), with the approval of the ethical committee at each local institution. Clinical data from these patients have been encouraging, supporting our laboratory data. Specifically, we treated two women and one man, aged 14, 65, and 54 years, respectively. Each patient suffered from a noncompliant bladder with reduced capacity (range 15-150 mL).

Operative time for the laparoscopic augmentation ureterocystoplasty ranged from two to three hours, and blood loss was 25 to 50 mL. Each patient commenced oral intake on the same day and ambulated within 24 hours. Hospital stay ranged from six to eight days. There were no infections or other complications at any stage of this study. Postoperatively, bladder capacity increased significantly to 250 to 280 mL at two-month follow-up. The first patient has now completed two-year follow-up with durable success. All three patients have experienced significant, even dramatic, improvement in voiding symptoms, and the renal function is well preserved.

The availability of a urothelium-lined, muscle-backed, vascularized, autogenous, in-line tissue material for purposes of augmentation, and possibly even replacement, of the urinary bladder would indeed be a major advance.

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