Gynecology

Three surgical procedures for genuine stress incontinence:

Five-year follow-up of a prospective randomized study
Arieh Bergman, MD, and Giovanni Elia, MD
Los Angeles, California

OBJECTIVE: Our purpose was to evaluate and compare the long-term results of the Kelly plication,
modified Pereyra needle suspension, and Burch urethropexy for the treatment of stress urinary
incontinence in women.
STUDY DESIGN: One hundred twenty-seven consecutive women underwent surgery at the gynecologic
urology division at Women’s Hospital, Los Angeles County-University of Southern California Medical
Center between January 1986 and June 1987. The only indication for surgery was stress urinary
incontinence. Women with previously failed antiincontinence procedures were excluded. Fifty-three
patients were premenopausal and 74 postmenopausal. History, physical examination, urethocystoscopy,
cotton swab test, filling cystometry, urethral pressure profile at rest and on cough, and uroflowmetry were
performed preoperatively, 3 months, 1 year, and 5 years postoperatively. The subjects and surgeons
were randomly allocated to one of three surgical procedures: group 1 had anterior colporrhaphy with
Kelly plication, group 2 had modified Pereyra needle urethropexy, and group 3 had Burch urethropexy.
One hundred seven women were available after 1 year, and 93 were the subjects of the 5-year
evaluation. Fisher exact text, x2, t test, and paired t test were used for statistical analysis.
RESULTS: The results of the l-year postoperative evaluation has been previously published. The
objective success rate for groups 1, 2, and 3 after 5 years was 37%, 43%, and 82%, respectively, and the
difference was statistically significant. The drop in the success rate in 4 years was 26%, 22%, and 7%
for groups 1, 2, and 3, respectively. Urodynamically all three procedures significantly increased the
abdominal pressure transmission to the urethra, when successful. Ninety-one percent of women after the
Burch procedure had a negative cotton swab test after 5 years compared with 46% for the Pereyra and
30% for the Kelly procedures.
CONCLUSIONS: In our hands the Burch urethropexy has a higher cure rate that holds over time when
compared with the modified Pereyra needle suspension and the Kelly plication. The lower incidence of
the positive cotton swab test in women after Burch urethropexy may be proof of a better anatomic
suspension of the bladder neck. (AM J OBSTET GYNECOL 1995;173:66-71.)

Key words: Surgical procedures, stress incontinence

Many surgical procedures have been proposed for Stamey, Raz, Gittes, etc.),3F7 and retropubic urethropexy
the treatment of stress urinary incontinence in women, (Marshall-Marchetti-Krantz, Burch).‘, ’
but they can all be placed in three main groups: vaginal The studies comparing the outcome of surgical pro-
plication of the bladder neck with sutures through the cedures are mainly descriptive and retrospective, with
pubocervical fascia (Kelly plication),‘, ’ needle suspen- very few performed in a prospective, randomized fash-
sion of the bladder neck (Pereyra, modified Pereyra, ion. 10.20In addition, very few objective data are available
on long-term results.“. ” The current study is intended
to evaluate the 5-year follow-up of women with stress
From the Division of Gynecologic Urology, ,Department of Obstet-
rics and Gynecology, University of Southern Calzfornia School of urinary incontinence in three groups of women under-
Medicine. going Kelly plication, modified Pereyra needle suspen-
Received for publication January 28, 1994; revised October 13, sion, and Burch bladder neck suspension.
1994; accepted November 18, 1994.
Reprint requests: Arieh Bergman, MD, Division of Gynecologic
Urology, Department of Obstetrics and Gynecology, University of Material and methods
Southern California School of Medicine, Women’s Hospital, Room One hundred twenty-seven consecutive women un-
L-1022, 1240 N. Mission Road, Los Angeles, CA 90033.
Copyright 0 1995 by Mosby-Year Book, Inc. derwent surgery at the gynecologic urology division of
0002-9378/95 $3.00 + 0 6/I/62309 Women’s Hospital, Los Angeles County-University of

66
Volume 173, Number 1 Bergman and Elia 67
Am J Obstet Gynecol

Southern California Medical Center, between January tion relating to urethral profilometry under rest and
1986 and June 1987. All women met the criteria for this stress were not considered in determining the type of
study and agreed to participate. The study protocol was procedure selected. Women in group 1 had a Kelly
approved by the Institutional Review Board of the procedure, women in group 2 had a modified Pereyra
University of Southern California. All women gave procedure, and women in group 3 had a Burch ure-
signed, informed consent forms. The only indication for thropexy.
surgery was stress urinary incontinence.“’ Only women Surgical technique and postoperative care have been
who considered their incontinence a social and hygienic previously described.” Anterior colporrhaphy was per-
problem and required intervention were included in the formed by mobilization of the bladder and its upward
study. Patients with any other gynecologic disease ne- displacement and by buttressing of the bladder neck
cessitating hysterectomy, other gynecologic operations, including the pubocervical fascia, by Kelly sutures. The
or other indications for laparotomy were not included modified Pereyra procedure included all modifications
in this study. Patients with previously failed antiincon- to the original technique, with special emphasis on
tinence procedures were also excluded. Mean age was inclusions of the pubourethral ligaments and endopel-
55 years (range 29 to 77 years), and mean parity was 3 vie fascia at the level of the proximal urethra and
(range 1 to 12). Fifty-three patients were premeno- bladder neck. The Burch urethopexy included the basic
pausal and 74 were postmenopausal. This study was principles of the Tanagho modification: (1) minimal
approved by the Institutional Review Board, and dissection within 2 cm of the urethrovesical junction
each patient was enrolled after giving signed, informed and urethra, (2) placement of sutures through full
consent forms. thickness of shiny white paravaginal fascia, (3) use of
Evaluation included history and physical examination two sutures on each side, one opposite to the ure-
(with special emphasis on neurologic screening tests of throvesical junction and another at the level of the
the S, to S, lower micturition center), negative urine midurethra, (4) removal of adipose tissue lateral to the
culture findings, cotton swab test (change of cotton sutures to stimulate fibrosis, and (5) facilitating typing
swab angle between resting and straining measured of sutures to the Cooper ligament with intravaginal
with an orthopedic goniometer with patients in the fingers elevating the anterior vaginal wall. After surgery
lithotomy position), dynamic water urethroscopy, stand- the bladder was drained by a suprapubic catheter (5F
ing provocative water urethrocystometry (at filling rate Bonnano catheter), and the catheter was removed once
of 60 mumin), and urethral profilometry in the sitting for postvoiding if residual urine volume was I 50 ml on
position, at rest, and during repeat coughing with two consecutive occasions before discontinuation of
bladder at maximal cystometric capacity. Pressures in bladder drainage. All procedures were performed with
the abdomen (approximated by vaginal recording), multifilament delayed absorbable sutures (polyglactin
bladder, and urethra were measured simultaneously 910, Vicryl l-0, Ethicon Inc., Somerville, N.J.). All
with two microtip (4F in diameter) pressure transducers surgical procedures were performed by house staff, and
(models 20K 60 and 20K 62, Dantec Electronics, Skov- one of the three surgeons involved in the study” was
lunde, Denmark) and recorded on a six-channel elec- selected for each procedure by means of a randomiza-
trophysiologic recorder (model 2 100, Dantec); neither tion list.‘”
evaluation technique nor instruments were changed Clinical and urodynamic evaluations were performed
throughout the study period. All postmenopausal at 3 months, 1 year, and 5 years after surgery with the
women who did not have estrogen replacement therapy same technique and the same equipment. One hundred
received conjugated estrogens (Premarin) vaginal seven patients were available for l-year postoperative
cream (1 gm every day) for 2 weeks before urodynamic evaluation; 64 of the 78 women cured at the l-year
evaluation and for 3 to 4 more weeks before surgery. All follow-up were available at 5 years. Cure was defined as
women were encouraged to continue estrogen replace- absence of complaint of persistent incontinence (sub-
ment therapy indefinitely. All women in this series had jective) and no evidence of loss of urine on cough
genuine stress incontinence (equalization of pressure profile during urodynamic evaluation with a microtip
between the bladder and urethra with stress and no transourcer catheter in the urethra at maximum cysto-
evidence of bladder instability).“’ Patients had various metric capacity (objective). Twenty-nine women who
degrees of cystocele, but none had a cystocele protrud- were documented failures at the l-year follow-up were
ing beyond the vaginal inlet during Valsalva maneuver included in our statistical analysis as failures at 5 years.
in the lithotomy position. Fourteen women were lost to follow-up because they
After clinical and urodynamic evaluation the patients relocated to an unknown residence. All the postmeno-
and surgeon were randomly allocated (by means of a pausal subjects available for follow-up were using estro-
randomization tables’) to one of three surgical proce- gen replacement therapy.
dures. The results of urodynamic studies and informa- All terminology conforms to that proposed by the
68 Bergman and Elia July 1995
Am J Obstet Gynecol

Table I. Results of three procedures at l- and 5-year follow-up

1 yrfollow-up (n = 107) 5 yrfollow-up (n = 93)

No. Cure (No., %) No. Cure (No., S)

Burch urethropexy 38 34 (89%) 33 27 (82%)

Modified Pereyra needle 34 22 (65%)” 30 13 (43%)*
suspension
Kelly plication 35 22 (63%)* 30 11 (37%)t

*p < 0.05 by t test, compared with Burch group.

tp < 0.01 by t test, compared with Burch group.

Table II. Comparison between data obtained with patients available and data adjusted for patients lost
to follow-up
Cure (%)

Adjusted with those lost Adjusted with those lost

Patients available to follow-up as to follow-up as
(n = 93) cure (n = 107) failure (n = 107)

Burch urethropexy 82 84 71
Modified Pereyra needle suspension 43* 50* 3s*
Kelly plication 37t 43 31t

*p i 0.05 by t test, compared with Burch group.

tp < 0.01 by t test, compared with Burch group.

International Continence Society, except where specif- significantly in patients who were cured of their incon-
ically mentioned.“’ Statistical analysis was performed tinence and remained so after 5 years.
with x’ with Yates’ correction, t test, and paired t test. Three subjects had detrusor instability during the
j-year interval and were considered failures. No voiding
Results difficulties were documented 5 years postoperatively.
Sixty-four of the 78 women cured 1 year postopera- One patient undergoing Burch urethropexy after 5
tively were available for evaluation after 5 years. Twenty- years was seen with a vaginal vault prolapse. Three
nine women who were documented failures 1 year after women with Kelly and two with Pereyra proceudres had
surgery were also included in the statistical analysis. grade 2 cystocele (to the vaginal introitus). Of the 29
Ninety-three of 107 subjects had a documented outcome women who had failures at the l-year follow-up, 12 had
between 1 and 5 years postoperatively: 33 after Burch Burch urethropexy, four had conservative manage-
urethropexy, 30 after modified Pereyra needle suspen- ment, and 13 were lost to follow-up.
sion, and 30 after Kelly plication. No significant differ- Table IV shows the results of the cotton swab test at
ence was found in the three groups for age, parity, and 1 and 5 years. All subjects with positive cotton swab tests
menopausal status. The outcome of the three proce- 1 year after operation were considered to have the test
dures is reported in Table I. The good results of the positive at the 5-year follow-up. The findings of the
Burch bladder neck suspension at 1 year (89% cure) were cotton swab test in the patients cured 1 year after
kept over time (82% cure at 5 years). Cures of the modi- surgery were matched with the outcome after 5 years
fied Pereyra and Kelly procedures (65% and 63% at 1 regardless of the surgical procedure. The results are
year) did not hold well over time (43% and 37%, respec- shown in Table V. The difference does not reach sta-
tively, cure rate at 5 years) (Table I). tistical significance (p = 0.06) probably because of in-
The results shown in Table II were obtained by sufficient power.
adjusting the data for the patients lost to follow-up.
Even when all patients unavailable for follow-up were Comment
considered as failures, still the cure rate of the Burch Surgical procedures for the treatment of genuine
bladder neck suspension (71% cure at 5 years) was stress urinary incontinence by bladder neck suspension
much better than that of modified Pereyra or Kelly can be divided in three main groups: vaginal plication
procedures (Table II). of the bladder neck,‘, ‘, p3, ‘* needle suspension of the
The urodynamic measurements are reported in bladder neck,3m’ and retropubic urethropexy.8, ’
Table III. The pressure transmission ratio improved The results reported in the literature after vaginal
Volume 173, Number 6 Bergman and Elia 69
Am J Obstet Gynecol

Table III. Urodynamic data on 93 patients operated on for stress urinary incontinence
PTR UCP UFL

Preoperatiue 1 Yr 5Y7” Preoperative 1 Yr 5Yr Preoperative 1 Yr 5 Yr

Burch urethro-
pexy (n = 38,
1 yr; n = 33,
5 yr)
Cure 82 i 19 112 +- 14* 101 i: 17” 44 -c 19 47 ? 201 49 -c 1st 3 2 1.4 3.1 ? 1.6t 3 f 1.5
Failure 83 i 20 92 I 7: 89 zk 6: 18 i 7 21 I6:: 25 c 101 1.7 +- 1.1 2.1 t 1.4: 2.3 i 1.3:
Pereyra needle sus-
pension (n = 34,
1 yr; n = 30,
5 yr)
Cure 84 k 16 103 t 17” 96 i 16* 47 + 20 50 2 23t 42 -c 20t 2.7 * 1.4 3.1 ? 1.5t 3.2 + l.lt
Failure 82 k 19 90 ” llt 89 + 1Qt 38 + 21 46 I? 24t 36 F 9t 2.8 -t 1.3 2.9 F 1.2t 2.9 i 1.3t
Anterior colporrhaphy,
Kelly plication
(n = 35, 1 yr;
72 = 30, 5 yr)
Cure 83 t 18 101 -c 16* 80 k 191 41 c 16 46 ? 18t 47 ? 15t 3.1 i- 1.1 3.3 ? 1.2t 3 * 1.6t
Failure 80 t 21 89 f 171 74 -t 14t 35 -c 21 42 ? 23t 44 f 22t 2.9 It 1.1 3 f 1.3t 3.1 -c 1.3t

Urodynamic studies on failures were performed on 64 patients at 5 years; 29 women with failure at 1 year did not have repeat
urodynamic studies at 5 years (I 2 had repeat operation, 4 had conservative treatment, 13 unknown). VCE Urethral closure pressure;
UFL, urethral functional length; PTR, pressure transmission ratio, which is as follows:

Abdominal pressure transmission to urethra

Pressure transmission ratio = x 100
Abdominal pressure transmission to bladder (measured at midurethra)

*p < 0.05 by two-tailed paired t test, compared with preoperative values.

tNo significant change by two-tailed paired t test, compared with preoperative values.
iStatistics not valid for six or fewer patients.

plication of the bladder neck show a success rate that is failures, the difference was still significant and the
usually lower compared with needle suspensions and success rate satisfactory (71%).
retropubic urethropexy. IF, “, ” The success rate re- What is also apparent from these data is that in our
ported for needle urethropexy is much higher, 100% by hands the Burch urethropexy holds over time better
Pereyra and LebherzzS or 96% by Raz.’ However, when than the needle suspension and the Kelly plication. The
the procedure is performed in a prospective compara- success rate between 1 and 5 years for the Burch went
tive fashion the reported cure appears to be as low as from 89% to 82% (7% drop), for the modified Pereyra
40%‘” and as high as 85%.13 The same authors that procedure from 65% to 45% (22% drop), and for the
reported a successful outcome of 96%6 in a more recent Kelly plication from 63% to 37% (26% drop). Urody-
study reported in a 5-year follow-up an 88% overall namically all three procedures significantly increased
success rate, with results as low as 65% in women with the abdominal pressure transmission to the urethra,
severe incontinence.‘6 Karram et al.” in a large series of when it was succesA1. Urethral closure pressure and
modified Pereyra procedures found, that although it functional length were not significantly affected, al-
had low morbidity, the procedure was successful in only though most women who had failure of the Pereyra or
63% of patients. Kelly procedures had lower urethral closure pressures.
The retropubic urethropexy, when compared with There are several reasons, in our opinion, for the
the previous two procedures, seems to have a better higher success rate of the retropubic urethropexy com-
outcome.‘3, IS-l7 There is no other study in the literature pared with needle and vaginal procedures. The former
that compares in a prospective, randomized fashion surgically approximates or suspends soft tissue (en-
three different procedures for stress urinary inconti- dopelvic fascia) to a strong ligamentous structure (Coo-
nence with long-term follow-up. per ligament), whereas the latter approximates or sus-
Our data show that by considering only the patients pends soft tissue (endopelvic fascia) to soft tissue (en-
available for follow-up the success rate for the Burch dopelvic fascia for the Kelly plication, rectus fascia for
procedure was significantly higher (82%) than for the the needle suspension). Furthermore, the extensive
other two procedures (45% and 37%); even when all the dissection performed during the Burch urethropexy
subjects unavailable for follow-up were considered as allows for a lager connective tissue reaction with conse-
70 Bergman and Elia July 1995
Am J Obstet Gynecol

Table IV. Bladder neck mobility and surgical results

Burch urethropexy Pereyra needle suspension Kelly #cation

1 yr 5 yr 1 Yr 5 yr 1 Yr 5 yr

Cure Failure Cure Failure Cure Failure Cure Failure Cure Failure Cure Failure
(n = 34) (n = 4) (n = 27) (n = 6) (n = 22) (n = 12) (n = 13) (n = 17) (n = 22) (n = 13) (n = 11) (n = 19)

0 (0%) 1 (25%) 1 (3%) 2 (33%) 13 (59%) 6 (50%) 4 (31%) 12 (71%) 15 (68%) 12 (92%) 3 (27%) 19 (100%)

Positive cotton swab test, change ~35 degrees.

Table V. Cotton swab findings at 1 year divide the subjects by severity of incontinence. A nec-
matched with outcome at 5 years for essary consideration is that criteria for cure were very
patients available for follow-up (n = 64) strict: the category of improvement was not included
because it was open to subjective bias. More than half of
Failure Cure
the patients that were defined failures considered their
Cotton swab test 13 22 operation a success but showed incontinence only dur-
positive (2 35
ing the cough stress test. We also tried to minimize
degrees)
Cotton swab test 4 25 subjective biases by performing the following evaluation
negative (< 35 in a blinded fashion (the physician was not aware of the
degrees)
procedure that had been performed in each patient). At
Positive predictive value 37%, negative predictive value 86%. the same time, the 5-year evaluation was performed by
the authors only, thus decreasing the investigator vari-
ability in interpreting results. Because of the small
number of failures, we could not identify as risk factors
quent scar tissue that fixes the endopelvic fascia to the
age or menopausal status. We concluded that the Burch
posterior surface of the symphysis pubis. A recent study
retropubic urethropexy in our hands has a significantly
compared lateral chain cystourethrography in conti-
higher long-term cure rate than the modified Pereyra
nent women and in women who had undergone suc-
procedure and the Kelly plication. The cotton swab test,
cessful Burch and Stamey urethropexies.‘* The authors
a simple, inexpensive test, can be a reliable predictor of
reported that the position of the urethrovesical junction
successful long-term outcome.
was significantly higher after the Burch procedure than
after Stamey procedure, and the first was similar to the
continent group. Confirming these findings, in our
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