Long-term followup of the North American multicenter UroLume trial for the treatment of external detrusor-sphincter dyssynergia.
OBJECTIVE
We determine the long-term efficacy and safety of the UroLume stent as minimally invasive treatment for external detrusor-sphincter dyssynergia in spinal cord injured men.


METHODS
A total of 160 spinal cord injured men with a mean age plus or minus standard deviation of 36.3 +/- 12.1 years (range 16 to 74) were prospectively treated with an endoprosthesis at 15 centers as part of the North American UroLume trial for external detrusor-sphincter dyssynergia. Urodynamic parameters, including voiding pressure, residual urine volume and bladder capacity, were compared before treatment and at 1, 2, 3, 4 and 5 years after treatment.


RESULTS
Mean voiding pressure was 75.1 +/- 28.2 cm. water before treatment in the 160 patients, and 37.4 +/- 23.9 at year 1 in 97, 39.5 +/- 22.2 at year 2 in 84, 42.6 +/- 27.3 at year 3 in 61, 46.3 +/- 33.2 at year 4 in 57 and 44.2 +/- 28.9 cm. at year 5 in 41 after stent insertion (p <0.001). Residual urine volume decreased after stent placement and was maintained throughout the 5-year followup (p <0.001). Mean cystometric capacity remained constant from 269 +/- 155 before insertion to 337 +/- 182 ml. 5 years later (p = 0.17). Hydronephrosis and autonomic dysreflexia improved or stabilized in most patients with functioning stents. Stent explant was necessary in 24 patients (15%), of whom 4 (16.7%) had another stent implanted.


CONCLUSIONS
The UroLume stent demonstrates long-term safety and efficacy for the treatment of external detrusor-sphincter dyssynergia. The outcome was similar in men with and without previous sphincterotomy.
Chancellor
M B
MB
University of Pittsburgh School of Medicine, Pennsylvania, USA.
Gajewski
J
J
Ackman
C F
CF
Appell
R A
RA
Bennett
J
J
Binard
J
J
Boone
T B
TB
Chetner
M P
MP
Crewalk
J A
JA
Defalco
A
A
Foote
J
J
Green
B
B
Juma
S
S
Jung
S Y
SY
Linsenmeyer
T A
TA
MacMillan
R
R
Mayo
M
M
Ozawa
H
H
Roehrborn
C G
CG
Shenot
P J
PJ
Stone
A
A
Vazquez
A
A
Killorin
W
W
Rivas
D A
DA
D000293:Adolescent; D000328:Adult; D000368:Aged; D001341:Autonomic Nervous System / Q000503:physiopathology; D002170:Canada; D005500:Follow-Up Studies; D006801:Humans; D006869:Hydronephrosis / Q000453:epidemiology / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010410:Penile Erection; D011183:Postoperative Complications / Q000453:epidemiology; D013119:Spinal Cord Injuries / Q000150:complications* / Q000503:physiopathology; D015607:Stents; D013997:Time Factors; D014481:United States; D014546:Urinary Catheterization; D014549:Urinary Incontinence / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D014552:Urinary Tract Infections / Q000453:epidemiology / Q000209:etiology; D014563:Urodynamics