OBJECTIVE: We sought to determine the long-term efficacy, safety, and urody
namic effects of the Mersilene mesh suburethral sling in treating complicat
ed forms of genuine stress incontinence.
STUDY DESIGN: Two hundred women diagnosed with genuine stress incontinence,
complicated by recurrence, intrinsic sphincter deficiency, or chronically
increased intraabdominal pressure underwent a suburethral mesh sling proced
ure (Mersilene; Ethicon Inc, Somerville, NJ). They were monitored with year
ly clinical examinations plus short- and long-term postoperative urodynamic
evaluations; statistical analysis was carried out by use of the Friedman 2
-way analysis by rank, Fischer-Freeman-H alton exact testing, analysis of v
ariance for repeated measures, Wilcoxon, exact Mann-Whitney U test, and Bon
ferroni paired t test. Of 176 patients who were 5 months or more postop, 12
7 (72%) had preoperative and short-term postoperative urodynamic evaluation
s (range 5 to 23 months, mean 12.6 months). Fifty-two of 117 women who were
more than 19 months postop (44%) completed preoperative and long-term post
operative urodynamic evaluations at a mean of 63 months (range 20 to 107).
One hundred thirty-six of 176 patients (77%) who were more than 4 months po
stop had a short- and/or long-term postoperative urodynamic evaluation (ran
ge 5 to 107 months, mean 30 months).
RESULTS: Objective cure rate by stress test was 93% (126 of 136 patients) a
t a mean of 30 months followup. The long-term objective cure rate was 94% (
49 of 52). Subjectively, the short- and long-term cure rates were 95.3% and
90.4%, respectively. The cotton swab angle deflection decreased by a mean
of 54 degrees at 1 year and 50 degrees at 5 years. Of the 10 failures, the
mean preoperative cotton swab straining angle was 19.6 degrees, with 6 bein
g < 30 degrees. Nineteen patients had a negative preoperative, cotton swab
angle test result (mean straining angle 15 degrees before operation, -6 deg
rees after operation) and a longterm cure rate of 67%. The objective cure r
ate in patients with positive cotton swab angle results monitored long term
(mean 62 months) was 100% (41 of 41). The postvoid residual increased by a
mean of 25 mL short term and 10 mL long term. Thirty-eight patients (19%)
had a total of 43 complications. Seven patients (3.5%) had long-term retent
ion. De novo detrusor instability occurred in 12 patients (8.8%), although
it was cured in 6 (4.4%). Eight patients (4%) had vaginal or inguinal sling
erosion and were healed after revision, Delayed healing at the vaginal sli
ng site responded completely to estrogen cream in two (1 %) patients. Five
women had treatable vaginal stenosis, 5 had a local inguinal collection/inf
ection unrelated to the mesh, and 3 required a 2-unit transfusion of packed
red blood cells. One patient each had an entrapped nerve released, a cysto
tomy repaired, or experienced thigh numbness or groin pain.
CONCLUSIONS: The suburethral Mersilene mesh sling has a very high long-term
objective and subjective cure rate in the treatment of complicated forms o
f genuine stress incontinence. Frequent complications do occur but are reme
diable. The 33% failure rate among patients with a preoperative negative co
tton swab angle test result and the very low cotton swab straining angle am
ong the 7% who had sling failures further confirms the widely held belief t
hat sling urethropexy in the absence of hypermobility lacks efficacy.