Full text of DOI:10.1016/S0022-5347(05)67557-X

0
022-5347/00/1636-1845/0
®
THE JOURNAL OF UROLOGY
Vol. 163, 1845–1848, June 2000
Copyright © 2000 by AMERICAN UROLOGICAL ASSOCIATION, INC.®
Printed in U.S.A.
PUBOVAGINAL SLING: 4-YEAR OUTCOME ANALYSIS AND QUALITY OF
LIFE ASSESSMENT
TED O. MORGAN, JR., O. LENAINE WESTNEY AND EDWARD J. McGUIRE*
From the Department of Urology, Tripler Army Medical Center, Honolulu, Hawaii, and Division of Urology, University of Texas–Houston,
Health Science Center, Houston, Texas
ABSTRACT
Purpose: Stress urinary incontinence is a common disease with a devastating impact on patient
quality of life. Needle suspension procedures, which produce disappointing long-term results for
type II stress incontinence, are being replaced by pubovaginal slings which previously were
reserved solely for the treatment of type III stress incontinence. We report the long-term
outcomes of pubovaginal slings for the treatment of types II and III stress urinary incontinence,
and assess its quality of life impact.
Materials and Methods: From January 1993 until December 1996, 247 females 10 to 84 years
old (mean age 54.5) with type II (54%) or III (46%) stress urinary incontinence diagnosed by
fluoroscopic urodynamics received a pubovaginal sling. Concomitant urge incontinence was
present in 109 patients (44%). Quality of life was assessed with the Urogenital Distress Inventory
short form.
Results: At a mean followup of 51 months (range 22 to 68) the continence rates were 88%
overall, 91% for type II and 84% for type III. Preoperative urge incontinence resolved in 81 of 109
patients (74%), while de novo urge incontinence developed in 10 (7%). Intermittent urethral
catheterization duration averaged 8.4 days, with 5 women undergoing urethrolysis for a hyper-
suspended urethra. Secondary procedures were required in 9 patients with type II and 5 with
type III incontinence, and included transurethral collagen injections in 6 and repeat pubovaginal
slings in 8. There was a 4% complication rate due to pelvic hematoma in 2 cases, incisional hernia
in 2, deep venous thrombosis in 1 and pulmonary embolus in 1. Of the 247 patients 235 (95%)
completed the quality of life questionnaire with 92% reporting a high degree of satisfaction with
low (less than 20 of 100 points) symptom distress scores.
Conclusions: Pubovaginal slings are effective and durable, and significantly improve quality of
life in patients with types II and III stress urinary incontinence.
KEY WORDS: urinary incontinence, stress; treatment outcome; quality of life; urethra; vagina
Presently urinary incontinence afflicts an estimated 13 cedure for types I and II, while type III stress urinary incon-
1
million adults in the United States alone. Due to the prev- tinence has been treated with collagen to restore urethral
alence of this condition and dramatic increase in public coapting ability in the absence of hypermobility of the blad-
awareness, urinary incontinence has come to the forefront der neck or a pubovaginal sling if hypermobility coexists with
and is now one of the most common presenting complaints in poor urethral closure. This classical algorithm has recently
the urological and gynecological specialties. In fact, in an been questioned as some clinicians have used the pubovagi-
attempt to understand better the impact of this devastating
problem, the World Health Organization concluded that uri-
nary incontinence should be recognized as a disease rather
3, 4
nal sling to treat all types of stress urinary incontinence as
a result of increasing dissatisfaction with the poor long-term
success rates with many of the bladder neck suspension
2
than a symptom or sign. During the last century there have
5–9
procedures.
been numerous advances in our understanding of the patho-
physiology of urinary incontinence with subsequent improve-
ments in medical and surgical treatment modalities. Unfor-
tunately, there is still a great deal to be learned, particularly
in providing accurate, long-term outcomes of the plethora of
surgical treatment options for patients with stress urinary
incontinence.
While the concept of suburethral support was originally
10
introduced in 1907 by Giordano, it was not until its rein-
troduction in 1978 by McGuire and Lytton that it gained
11
increased clinical use. Unfortunately, the wholesale accep-
tance of pubovaginal slings by the urological and gynecolog-
ical communities has been limited by the historically higher
incidence of complications with pubovaginal slings, namely,
sling erosion, de novo detrusor instability and urinary reten-
tion. It appears that sling erosion is directly related to use of
allogenic material for the sling, with most contemporary
series reporting no erosions with autologous or donor fascia
The standard classification differentiates stress urinary
incontinence due to poor anatomic support mechanisms
(
types I and II) from incompetence of the bladder neck and
proximal urethral closure mechanism (type III). Treatment
has consisted of a retropubic or transvaginal suspension pro-
1
2–16
pubovaginal slings.
A 2% to 12% incidence of urinary
retention (greater than 4 weeks) is approximately 80% more
Accepted for publication January 28, 2000.
Presented at annual meeting of American Urological Association, common after pubovaginal slings compared with other anti-
Dallas, Texas, May 1–6, 1999.
incontinence procedures. On the other hand, de novo
detrusor instability with incidence rates of 3% to 24% is not
unique to or more common with pubovaginal slings.
Clearly, to appreciate the clinical value of a treatment
4, 15–17
The opinions or assertions contained herein are the private views
of the authors and are not to be construed as reflecting the views of
the United States Army or the Department of Defense.
1
7
*
Financial interest and/or other relationship with Bard Urologic.
1845

1
846
QUALITY OF LIFE WITH PUBOVAGINAL SLING
modality for stress incontinence, one needs to look not only at
Postoperative evaluation. Followup included a routine ex-
cure rates and side effects, but also the life impact and amination 4 weeks and 3 months postoperatively. Informa-
patient satisfaction with the treatment. Previously this as- tion obtained at followup included duration of intermittent
sessment has been based entirely on medical records from self-catheterization, pad usage and urgency. A pelvic exam-
which patient complaints have been extracted and graded by ination was performed in patients who underwent a concur-
a reviewer. To provide a more accurate assessment of patient rent vaginal procedure. If patients complained of obstructive
satisfaction without any inherent bias, self-administered symptoms or persistent incontinence, or required intermit-
standardized questionnaires have been developed.18 We re- tent self-catheterization at 3 months postoperatively fluoro-
port our experience using rectus fascia pubovaginal slings for scopic urodynamics were repeated. Patients were believed to
the treatment of stress urinary incontinence, and define pre- have a hypersuspended proximal urethra when fluoroscopy
operative factors that could predict long-term outcome re- revealed a concave deformity of the urethra being supported
garding continence rates, complications and, most impor- by the pubovaginal sling with no demonstrable mobility. To
tantly, patient satisfaction.
evaluate long-term outcome and patient satisfaction the Uro-
genital Distress Inventory short form was mailed to all pa-
tients (see Appendix). This instrument is a previously val-
idated tool used to assess symptom distress and quality of life
1
8
MATERIALS AND METHODS
Preoperative evaluation. From January 1993 until Decem- with urinary incontinence, and provides objective meas-
ber 1996, 247 women received a rectus fascia pubovaginal urements to evaluate outcomes of treatment modalities. To
sling. Preoperative evaluation for all patients included a test the validity of the questionnaire a telephone retest was
urogynecological history and physical examination, urinaly- conducted on all patients who responded to the question-
sis and fluorourodynamics. Video urodynamics consisted of naire. A physician not involved with the original procedure
simultaneous measurement of the bladder and external (T. M.) performed the chart review, retest and data analysis.
sphincter pressures during filling with 20% iodinated con-
Statistical analysis. Data analysis was performed with
trast material at a rate of 100 ml. per minute. During filling commercial statistical software. Univariate analysis (un-
the bladder was assessed for compliance, bladder neck com- paired t test) was used to identify noncontinuous preopera-
petency, sensation, uninhibited detrusor contractions and tive variables predictive of continuous outcome variables
vesicoureteral reflux. Urethral function with the bladder such as continence status. Chi-square cross table analysis
filled to 200 to 250 ml. was evaluated by determining the was used to investigate relationships between noncontinuous
19
abdominal leak point pressure. Urethral hypermobility was preoperative and outcome variables. Bivariate analysis was
assessed with the patient in an oblique upright position used to identify continuous preoperative and postoperative
using radiopaque marker movement during a Valsalva ma- variables predictive of outcome variables. Coefficient corre-
neuver, and was demonstrated when there was greater than lations of greater than 0.3 were considered important and p
2
cm. mobility of the bladder neck.
Ͻ0.05 was considered significant. For the test-retest analysis
Stress urinary incontinence was classified as type II— a paired t test was used for continuous variables and a ␬
abdominal leak point pressure greater than 90 cm. water and statistic was generated measuring agreement between the 2
urethral mobility greater than 2 cm., type III—abdominal tests.
leak point pressure less than 60 cm. water, and type II/III—
abdominal leak point pressure between 60 and 90 cm. water
in combination with urethral hypermobility. For data analy-
sis all cases with abdominal leak point pressure less than 90
cm. water were considered as type III stress urinary incon-
tinence.
RESULTS
Mean age of our patients was 54.5 years (range 10 to 84),
and 54% had type II (133 patients) and 46% had type III (114)
stress urinary incontinence (table 1). At a mean followup of
5
2
2 months (range 24 to 70) chart review was performed on all
47 patients and the Urogenital Distress Inventory short
Surgical technique. The surgical technique used has been
1
1
previously described and has had only minor modifications.
form was mailed to all patients. Of the 247 patients 235
Briefly, after placement of a Foley catheter a 6 to 8 ϫ 1 to 1.5
cm. rectus fascia sling is harvested through a Pfannenstiel
incision and secured at the ends with a 1-zero polyglactin
suture. An inverted U or midline vaginal incision is centered
over the proximal urethra, and the endopelvic fascia is
sharply perforated lateral and distal to the bladder neck,
thus entering into the retropubic position.
(
95%) responded to the questionnaire and all responders
were retested by telephone.
Complete resolution of stress urinary incontinence with no
urge incontinence was reported by 88% of the 247 patients,
including 91% (121 patients) with type II and 84% (96) with
type III stress urinary incontinence. To achieve this level of
cure, secondary procedures were performed in 14 patients.
The sling sutures are passed from the vaginal incision to
the abdominal incision lateral to the rectus muscle using a
Sarot or Crawford clamp. The sling is tacked to the periure-
thral fascia in the midline at the bladder neck with a 3-zero
delayed absorbable suture. The vaginal mucosa is closed with
a 2-zero chromic suture in an interrupted or running locking
fashion. The sling sutures are brought out through the infe-
rior leaf of the rectus fascia and the fascia is closed with
TABLE 1. Patient demographics
Type II
Type III
No. pts.
133
51.4
3.2/2.9
3.9
114
54.2
3.6/3.1
4.2
Mean age
Mean gravity/parity
Mean pads/day
No. concurrent procedures:
Cystocele
Rectocele
1
-zero polyglactin in a running fashion. The sling sutures are
tied across the midline over the rectus fascia with the least
amount of tension required to prevent urethral motion,
which is usually confirmed when 1 to 2 fingers are able to
pass between the sling suture knot and the rectus fascia.
The abdominal wound is closed and a povidone-iodine,
triple sulfa or estrogen cream impregnated gauze is used to
pack the vagina. The Foley catheter is removed on the morn-
ing after surgery or as soon as the patient is ambulating. All
patients are instructed on intermittent self-catheterization,
which is performed until the post-void residual is less than 60
ml.
37
12
4
7
5
11
72%
46%
108
49
10
2
Sacrospinalis ligament fixation
Vaginal hysterectomy
Abdominal hysterectomy
Enterocele
9
6
8
% Preop. urgency
74%
43%
42
%
Preop. urge incontinence
Mean abdominal leak point pres-
2
sure (cm./H O)*
Mean previous surgery (range)†
0.9 (0–3)
2.4 (0–8)
*
p ϭ 0.01.
† p Ͻ0.001.

QUALITY OF LIFE WITH PUBOVAGINAL SLING
1847
Transurethral collagen injections were administered postop-
TABLE 2. Complications of rectus fascia pubovaginal sling
Complications No. Pts. (%)
Sling failure
Hypersuspended urethra
Pelvic hematoma
Incisional hernia
Deep venous thrombosis
Pulmonary embolus
Sling erosion
eratively in 6 patients with type III stress urinary inconti-
nence and all are now continent. Repeat pubovaginal slings
procedures were performed in 3 cases originally classified as
type II and 5 type III cases. In all 8 cases urodynamics
confirmed a low abdominal leak point pressure (less than 60
cm. water pressure) and no evidence of suburethral support.
The initial sling failed 45 days postoperatively in 7 cases and
8 (3.2)
5 (2.4)
2 (0.8)
2 (0.8)
1 (0.4)
1 (0.4)
0
6
months postoperatively in 1. Stress urinary incontinence
persisted in 1 case, for a success rate of 87% for repeat
pubovaginal sling. No patients had recurrent stress urinary
incontinence after 6 months postoperatively and cure rate
was 85% in 88 patients now followed for greater than 5 years
the answers ranging from “not at all” to “greatly” with a
corresponding raw score of 0 to 3, respectively. The sum of
the raw scores was made into a 100-point scale, with a net
score of less than 20 being defined as experiencing a high rate
of satisfaction with outcome. Overall 92% of the group were
highly satisfied, with a mean distress score of 16 Ϯ 3 (range
(
see figure).
Of the 109 patients with preoperative concurrent urge
related incontinence, defined as involuntary loss of urine
precipitated by urge as reported by the patient, 81 (74%) had
complete resolution postoperatively. No preoperative vari-
able predicted resolution of urge incontinence postopera-
tively but concurrent anterior colporrhaphy correlated most
closely with resolution of urge incontinence (p ϭ 0.07). There
was no difference in outcome when patients were evaluated
according to the grade of cystocele. Of the 138 patients with
pure stress urinary incontinence preoperatively 32 (23%) had
de novo urgency, including 10 with associated incontinence,
for an overall de novo urge incontinence rate of 7%.
0
to 48). As expected, patients with persistent urge related
incontinence reported the lowest degree of satisfaction (p
Ͻ0.001). Interestingly, despite experiencing similar out-
comes, patients with de novo urge incontinence (mean score
2
4 Ϯ 4) did not report the same degree of distress as those
with persistent urge incontinence (mean score 44 Ϯ 5) (p ϭ
.01). Multivariate analysis only weakly correlated preoper-
ative urgency with high distress scores postoperatively (r ϭ
.293, p ϭ 0.04).
0
0
Transient postoperative urinary retention requiring inter-
mittent self-catheterization was the most common side effect
of the pubovaginal sling, with 94% of patients requiring
DISCUSSION
It has become increasingly clear to patients and health care
catheterization more than 1 day postoperatively. Mean du- providers that to determine more accurately the efficacy of any
ration of catheterization was 8.4 days, and normal voiding treatment modality, the impact of the intervention on patient
began 1 week, 1 month and 3 months postoperatively in 53%, quality of life must be evaluated and reported. This fact partic-
9
2% and 98% of the patients, respectively. There was no ularly applies to the treatment of stress urinary incontinence as
statistical difference in time to return to normal voiding with the number of surgical techniques dramatically increases.
respect to preoperative variables or concurrent procedures Therefore, the onus remains on the urological community to
performed. In the 5 women with prolonged (greater than 3 provide this information to allow our patients the opportunity to
months) urinary retention, urethrolysis resolved the urody- make a more informed decision regarding therapy. By using a
namically confirmed hypersuspended proximal urethra with previously validated quality of life impact questionnaire, we
subsequent return to normal voiding in 80%. There were no found an overwhelmingly high degree of patient satisfaction
cases of sling erosion or requirement to remove the sling or with the rectus fascia pubovaginal sling for the treatment of
suture material. Table 2 summarizes the other complications types II and III stress urinary incontinence. While we did not
with the rectus fascia pubovaginal sling.
measure the change in quality of life after the pubovaginal sling
Of the 235 patients (95%) who responded to the mailed compared to preoperative assessment, we believe that the low
Urogenital Distress Inventory short form all (100%) were distress scores are attributed directly to the surgical procedure.
retested via telephone with a high correlation of agreement Preoperative distress is inferred in that all patients originally
(
mean ␬ 0.91 Ϯ 0.05, p Ͻ0.0001). Patient satisfaction with presented with the complaint of urinary incontinence, rather
outcome was inferred when they reported a low distress than the population being derived from a screening program.
symptom score. The questions were equally weighted with Furthermore, when asked if they would undergo the procedure
again, 92% of the patients responded positively, stating satis-
faction with the procedure.
Haab et al found a similarly high degree of patient satis-
faction despite a failure rate of 54% in 40 patients with a
2
0
mean followup of 4 years. We found that life quality directly
correlated with outcome, as women with postoperative urge
incontinence had the highest distress scores (mean 38, range
1
8 to 48) with only 1 reporting a willingness to undergo the
procedure again (p Ͻ0.001). When compared to 217 women
with resolution of urinary incontinence 98% reported low
(
less than 20) distress scores, clearly suggesting that patient
satisfaction directly correlated with continence status.
To avoid the inherent overreporting of cure with a retrospec-
tive chart review, we determined continence status based on
patient survey. With a mean duration since surgery of more
than 4 years, 88% of the women reported complete absence of
urinary incontinence. Most impressive was the durability of the
pubovaginal sling, as of the 88 patients followed longer than 5
years 85% report complete absence of stress urinary inconti-
nence. Our results are similar to those of other long-term fol-
lowup series, particularly that of Chaikin et al, who reported
9
5% cure of stress incontinence in 20 patients followed for 10
Durability of cure from stress urinary incontinence after rectus
fascia sling.
4
years. Taken together, these reports demonstrate that when

1
848
QUALITY OF LIFE WITH PUBOVAGINAL SLING
stress incontinence is resolved for more than 1 year after a
pubovaginal sling, the long-term (5 to 10 years) risk of recurrent
stress incontinence is low.
Agency for Health Care Policy and Research, Public Health
Service, U.S. Department of Health and Human Services,
1996
Previously a great concern about the pubovaginal sling was
that it converted an incompetent bladder neck and proximal
urethral closure mechanism into an obstructing system, which
in the long term would theoretically create detrusor instability.
This concern was suggested by Chaikin et al, when they found
a 23% incidence of detrusor instability at 1 year which in-
2. Chancellor, M. B.: Mapping the future for incontinence treat-
ment worldwide. Rev Urol, 1: 145, 1999
. Zaragoza, M. R.: Expanded indications for the pubovaginal sling:
3
4
5
treatment of type 2 or 3 stress incontinence. J Urol, 156: 1620,
1996
. Chaikin, D. C., Rosenthal, J. and Blaivas, J. G.: Pubovaginal
fascial sling for all types of stress urinary incontinence: long-
term analysis. J Urol, 160: 1312, 1998
. Kelly, M. J., Knielsen, K., Bruskewitz, R. et al: Symptom anal-
ysis of patients undergoing modified Pereyra bladder neck
suspension for stress urinary incontinence. Pre- and postoper-
ative findings. Urology, 37: 213, 1991
. Walker, G. T. and Texter, J. H.: Success and patient satisfaction
following the Stamey procedure for stress urinary inconti-
nence. J Urol, 147: 1521, 1992
7. Korman, H. J., Sirls, L. T. and Kirkemo, A. K.: The success rate
of modified Pereyra bladder neck suspension determined by
outcomes analysis. J Urol, 152: 1453, 1994
8. Trockman, B. A., Leach, G. E., Hamilton, J. et al: Modified
Pereyra bladder neck suspension: 10-year mean followup us-
ing outcome analysis in 125 patients. J Urol, 154: 1841, 1995
. Das, S.: Comparative outcome analysis of laparoscopic colposus-
pension, abdominal colposuspension and vaginal needle sus-
pension for female urinary incontinence. J Urol, 160: 368,
4
creased to 41% at 10 years. Unfortunately, they did not discuss
whether this increase in incidence was secondary to new cases
developing with time or if it resulted from a decrease in the
number of evaluable patients with the same absolute number of
urge incontinence cases. In our series we have found no evi-
dence to support this concern. In fact, of the 32 patients with de
novo urgency 29 (91%) presented within 1 year postoperatively.
Furthermore, no variable, not even aging as previously sug-
gested, predicted the development of de novo urgency with or
without incontinence.
6
The opposite extreme of incontinence is urinary retention,
with incidence rates ranging from 0% to 12% in contempo-
rary series.1
4, 15–17
The trend in these series is clearly a lower
retention rate with increasing surgeon experience. The most
important aspect of preventing this complication is to avoid
placing any tension on the sling, unless permanent intermit-
tent self-catheterization is the desired outcome. When the
sling was placed so that it minimized bladder neck hypermo-
bility, normal voiding returned within 30 days postopera-
tively in 9 of 10 cases.
9
1998
1
1
0. Giordano, D.: Twentieth Congress, Franc de Chir, 506, 1907
1. McGuire, E. J. and Lytton, B.: Pubovaginal sling procedure for
stress incontinence. J Urol, 119: 82, 1978
1
2. Barbalias, G., Liatsikos, E. and Barbalias, D.: Use of slings made
of indigenous and allogenic material (Goretex) in Type III
urinary incontinence and comparison between them. Eur Urol,
CONCLUSIONS
The pubovaginal sling is highly effective for types II and III
stress urinary incontinence. Secondary to its low morbidity and
high rate of cure with proved durability of greater than 5 years,
the pubovaginal sling produces a high degree of patient satis-
faction. Patients with preoperative urge incontinence and a
3
1: 394, 1997
1
1
1
3. Ahmed, M. M., Hai, M. A., Ibrahim, S. A. et al: Outcomes fol-
lowing polypropylene mesh pubovaginal slings for stress in-
continence. J Urol, 161: 106, abstract 397, 1999
4. Leach, G. E., Kobashi, K. C., Mee, S. L., et al: Erosion of woven
polyester synthetic (“Protegen”) pubovaginal sling. J Urol,
2
6% incidence of failure are at greatest risk for postoperative
dissatisfaction and, therefore, they should be carefully coun-
seled preoperatively. However, nearly three-fourths of this high
risk group have excellent outcomes with complete resolution of
urge and stress incontinence following the sling procedure.
With this information and previous reports of equal outcomes in
elderly and/or obese women, all patients with type II or III
stress urinary incontinence should be considered excellent can-
didates for a pubovaginal sling.21, 22
1
61: 106, abstract 400, 1999
5. Litwiller, S. E., Nelson, R. S., Fone, P. D. et al: Vaginal wall
sling: long-term outcome analysis of factors contributing to
patient satisfaction and surgical success. J Urol, 157: 1279,
1997
1
6. Govier, F. E., Gibbons, R. P., Correa, R. J. et al: Pubovaginal
slings using fascia lata for the treatment of intrinsic sphincter
deficiency. J Urol, 157: 117, 1997
7. Leach, G. E., Dmochowski, R. R., Appell, R. A. et al: Female
Stress Urinary Incontinence Clinical Guidelines Panel sum-
mary report on surgical management of female stress urinary
incontinence. J Urol, 158: 875, 1997
8. Uebersax, J. S., Wyman, J. F., Shumaker, S. A. et al: Short forms
to assess life quality and symptom distress for urinary incon-
tinence in women: the Incontinence Impact Questionnaire and
the Urogenital Distress Inventory. Neurourol Urodyn, 14: 131,
1995
1
APPENDIX: UROGENITAL DISTRESS INVENTORY SHORT FORM
(
UDI-6)
Do you experience, and if so, how much are you bothered
by:
1
1
2
3
. Frequent urination?
. Urine leakage related to the feeling of urgency?
. Urine leakage related to physical activity, coughing,
or sneezing?
19. McGuire, E. J., Fitzpatrick, C. C., Wan, J. et al: Clinical assess-
4
5
6
. Small amounts of urine leakage (drops)?
. Difficulty emptying your bladder?
. Pain or discomfort in the lower abdominal or genital
area?
ment of urethral sphincter function. J Urol, 150: 1452, 1993
2
0. Haab, F., Trockman, B. A., Zimmern, P. E. et al: Results of
pubovaginal sling for the treatment of intrinsic sphincter de-
ficiency determined by questionnaire analysis. J Urol, 158:
1738, 1997
Item response levels are: (0) not at all; (1) slightly; (2)
moderately; (3) greatly.
2
2
1. Carr, L. K., Walsh, P. J., Abraham, V. E. et al: Favorable out-
come of pubovaginal slings for geriatric women with stress
incontinence. J Urol, 157: 125, 1997
2. Cummings, J. M., Boullier, J. A. and Parra, R. O.: Surgical
correction of stress incontinence in morbidly obese women.
J Urol, 160: 754, 1998
REFERENCES
1
. Urinary Incontinence in Adults Guideline Update Panel: Clini-
cal Practice Guideline on Urinary Incontinence in Adults.