Seven-Year Follow-up of the Tension-Free Vaginal
Tape Procedure for Treatment of Urinary
Carl Gustaf Nilsson, MD, PhD, Christian Falconer, MD, PhD, and Masoumeh Rezapour, MD, PhD
OBJECTIVE: To evaluate the long-term cure rates and late
complication rates after treatment of female urinary stress
incontinence with the minimally invasive tension-free vag-
inal tape operation.
METHODS: Prospective observational, 3-center cohort study
originally of 90 women requiring surgical treatment for
primary urinary stress incontinence. Assessment variables
included a 24-hour pad weighing test, a stress test, visual
analog scale for assessing the degree of bother, and a
questionnaire assessing the subjective perception of the
women on their continence status.
RESULTS: The follow-up time was a mean of 91 months
(range 78–100 months). Both objective and subjective cure
rates were 81.3% for the 80 women available for follow-up.
novo urge symptoms in 6.3%, and recurrent urinary tract
effects of the procedure were detected.
CONCLUSION: The tension-free vaginal tape procedure for
treatment of female urinary stress incontinence is effective
over a period of 7 years.
1259–62. © 2004 by The American College of Obstetri-
cians and Gynecologists.)
LEVEL OF EVIDENCE: II-3
(Obstet Gynecol 2004;104:
During the past decade a number of new minimally
invasive surgical procedures for treatment of female
clinical use. This is perhaps a reflection of modern health
care, which strives to provide the individual and the
society with rapid, resource-saving, and cost-effective
treatment. Not only cure in the sense of dryness but also
quality of life have become important outcome measures
when assessing results of treatment of female urinary
incontinence. Quality of life can be defined in many
ways, of which one is the absence of short- or long-term
complications in association with cure.
Low cure rates and high complication rates have been
a concern among those studying many of the minimally
invasive procedures. Endoscopic colposuspension, peri-
urethral bulking agents, and needle suspension proce-
dures have been associated with either unacceptable
complications or rapidly declining cure rates1–3
The tension-free vaginal tape (TVT) procedure for
treatment of female stress incontinence has become a
widely used new minimally invasive operation probably
due to the fact that it has been systematically and pro-
of cure in primary cases of stress incontinence,4–6in
recurrent cases,7,8in cases of mixed incontinence,6,9and
in cases with intrinsic sphincter deficiency.10A nation-
wide survey of the incidence of intraoperative and post-
operative complications in connection with the TVT
procedure has been performed in Finland. The results of
this survey indicate a low rate of complications, even
though the learning curve of the performing surgeons
was included in the material.11
High long-term cure rates enhance the cost-effective-
ness of a given treatment. Five-year follow-up results of
the TVT procedure have been published.12The cure
effective traditional, but more invasive, surgical inconti-
nence procedures. The aim of the present study was to
evaluate the continence status 7 years postoperatively of
the women included in one of the earliest prospective
MATERIALS AND METHODS
Ninety consecutive patients suffering from urodynami-
cally proven stress incontinence had a tension-free vagi-
nal tape procedure performed between January 1, 1995,
and October 15, 1996. The trial was a prospective 3-cen-
From the Department of Obstetrics and Gynecology, Helsinki University Central
Hospital, Helsinki, Finland; Danderyd Hospital, Stockholm, Sweden; and De-
partment of Obstetrics and Gynecology, Uppsala University Hospital, Uppsala,
The authors recognize Ulf Ulmstead, MD, PhD, deceased March 2004, for his
contribution to this study.
VOL. 104, NO. 6, DECEMBER 2004
© 2004 by The American College of Obstetricians and Gynecologists.
Published by Lippincott Williams & Wilkins.
cases of stress incontinence, with no prior incontinence
surgery. Twenty-five women reported symptoms of
urge. Symptoms of urge included frequency more than 8
per day, urgency and nocturia more than 2 per day.
Women with detrusor instability on preoperative urody-
pressure less than 20 cm H2O. Women with grade I
cystocele not requiring surgical intervention were in-
The study protocol included preoperative urody-
namic studies (micro tip urethrocystometry and urethral
profilometry) in a sitting position according to previ-
ously described techniques13), a stress test (cough prov-
ocation) in the sitting or standing position with a bladder
volume of 300 ml, a 24-hour pad-weighing test,14a 2-day
voiding diary, and residual urine measurements.
At postoperative follow-up visits the stress test, the
24-hour pad-weighing test, and the 2-day voiding diary
were repeated. Postoperative quality of life was assessed
by using a visual analog scale (VAS) where 0 represents
no urinary problems and 100 unbearable urinary com-
A questionnaire was used in which the women stated
whether they felt that they were cured of their inconti-
nence or that they were improved or that treatment had
failed. The women were also asked whether their conti-
nence situation was unchanged, improved, or worse
compared with the situation at their previous 5-year
follow-up visit.12Changes in medical history since the
5-year visit were recorded, and a gynecologic examina-
tion was performed.
The TVT procedure was carried out as described in
detail previously.15All operations were performed un-
der local infiltration anesthesia using 0.25% prilocaine
pylene tape was used (Gynecare TVT, Ethicon Inc.,
Somerville, NJ). Cystoscopy was performed twice dur-
ing the operation, after each retropubic pass of the TVT
needle to detect bladder injuries. Adjustment of the
test. The patients were asked to cough strongly at a
bladder volume of 300 ml. A few drops of saline were
allowed to escape the external meatus of the urethra to
avoid postoperative voiding difficulties. Postoperatively
the patients were regarded as objectively cured if they
had a negative stress test and a negative 24-hour pad-
weighing test (less than 8 g per 24 hours).
The ethics committees of the 3 centers, Helsinki Uni-
versity Hospital, Danderyd Hospital, Stockholm, and
Uppsala University Hospital, approved the study. All
women gave informed consent to participation in the
at the time of the 7-year follow-up visit. Six women lived
in nursing homes, being disabled to a degree that they
could not be evaluated, and 1 woman was completely
lost to follow-up. Eighty women could be reached, 16 of
them only by telephone due to various reasons (living in
nursing homes or moved away from the region). Only
subjective assessment using the questionnaire was per-
the clinics and be fully evaluated. The patient character-
istics are shown in Table 1.
The mean follow-up time was 91.1 (range 78–100)
the clinics, 54 (84.4%) had a negative pad test, 7 (10.9%)
3 women refused to perform the pad test, claiming they
were completely dry.
The stress test was not possible to perform in the
standardized way in 3 women, and the remaining 61
(95.3%) women had a negative stress test. The criteria
for objective cure were met by 81.3% of the clinically
The results of the subjective evaluation of 80 women
reached for follow-up are presented in Table 2. Both the
objective and subjective cure rate was 81.3%.
Table 1. Subject Characteristics
Age at 7-year follow-up (y)
Menopausal at time of surgery
Urge symptoms preoperatively
Duration of incontinence symptoms (y)
Follow-up time (mo)
Values are median and (range) or percentage.
Table 2. Subjective Evaluation of Continence Status at
Follow-up status compared with
Change in continence status
since 5-year follow-up visit
Claiming dry on stress
VAS score ? 10 (scale 0–100)
VAS, visual analog scale.
1260Nilsson et al
Seven Years TVT Follow-up
OBSTETRICS & GYNECOLOGY
Eighteen (22.5%) of the evaluated 80 women had
symptoms of urge. Table 3 shows the medical status of
these 18 women. Asymptomatic pelvic organ prolapse,
grade I–II and not requiring surgical intervention, was
seen in 5 (7.8%) of the 64 women seen at the clinics.
Recurrent urinary tract infections were reported by 6
(7.5%) of 80 women interviewed. Five (6.3%) of 80
reported de novo urge symptoms. None of the women
complained of voiding difficulties, and no sign of tape
material rejection could be seen or was reported.
A commonly encountered problem with new promising
surgical procedures for treatment of female stress incon-
tinence is the difficulty of predicting the effectiveness of a
given treatment over time. A systematic prospective
Long-term follow-up, however, is associated with a
growing proportion of the original subjects being lost to
follow-up. Interestingly, in our study, of 90 women who
were originally enrolled, 80 were amenable to follow-up
after 7 years and 64 of 90 (71%) could be clinically
evaluated according to the protocol. Only 1 patient was
completely lost to follow-up. Another 9 patients could
not be evaluated due to death unrelated to the treatment
or were severely disabled by illness. Some of the patients
were elderly, a few over 90 years of age. The lower the
rate of those lost to follow-up, the more reliably cure
rates reflect the true durability of effectiveness of treat-
ment in a certain population. Therefore, a cure rate of
more than 80% in a population such as the present one
has to be regarded as reassuring. Long-term cure rates of
around 70–80% have been reported for the open Burch
colposuspension operation, regarded as the standard for
traditional incontinence procedures.16,17Long-term cure
rates for less invasive incontinence procedures such as
needle suspensions and periurethral bulking agents have
been rather disappointing, ranging between 5% and
48%.18–20In our current study, 97.5% of the women
regarded the TVT operation as successful. When com-
paring their continence status at 7 years of follow-up to
that at the prior 5-year visit, 88% felt that the situation
was unchanged, but 5% felt that they had improved, and
8% felt that their situation had become worse. This
perhaps reflects changes in health status and life style
more than the actual mechanism of action of the tension-
Importantly, no signs of tape erosion or any tissue
reactions indicating tape material rejection were found.
In an aging population many illnesses occur that are
known to affect bladder function, causing symptoms of
overactivity, including incontinence. The patients’ sub-
affected by these conditions and consequently does not
necessarily reflect the effectiveness with which an oper-
ation cures stress incontinence. Eighteen of the women
in the present study presented with symptoms of an
overactive bladder at their 7 years follow-up visit. Thir-
teen had diseases or conditions that commonly are asso-
ciated with bladder problems. Only 5 women were
thought to have de novo urge symptoms unrelated to
any known illnesses. Whether the urge symptoms of
these women are directly associated with the TVT oper-
ation, performed 7 years earlier, is a question of debate.
In any case, the rate of urge problems with the TVT
procedure seems to be low in comparison with tradi-
tional incontinence surgery.2
Quality of life can be assessed in many ways. Generic
instruments for measurement of health-related quality of
life have been relatively insensitive for use in assessing
the impact of urinary incontinence on quality of life and
treatment efficacy.21The visual analog scale is a gener-
ally accepted tool in research concerning measurement
of the impact of disease and effects of medical interven-
tion on health-related quality of life and had also been
successfully used in urinary incontinence studies22–24.
As Stach-Lempinen et al25have shown, the VAS is an
treatment for women suffering from urinary inconti-
nence. We therefore chose this instrument for assessing
quality of life and believe that the VAS nicely reflects
how objectively assessed cure influences women’s per-
ception of changes in quality of life. The absence of
long-term adverse events associated with the TVT oper-
ation and high subjective and objective 7-year postoper-
ative cure rates make the TVT operation a recommend-
able surgical treatment for female stress urinary
Gynecol Scand 1998;77suppl:29–33.
2. Jarvis GJ. Surgery for genuine stress incontinence. BJOG
Table 3. Medical Status of 18 Women With Urge Symp-
toms at 7-Year Follow-up
Diabetes mellitus with neuropathy
Serious cardiovascular disease
De novo urge unrelated to any disease
VOL. 104, NO. 6, DECEMBER 2004
Nilsson et al
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Reprints are not available. Address correspondence to: Carl
Gustaf Nilsson, Department of Obstetrics and Gynecology,
Helsinki University Central Hospital, Haartmaninkatu 2, Hel-
sinki, POB 140,00029 HUS, Finland; e-mail: carl.nilsson@
Received May 19, 2004. Received in revised form August 19, 2004.
Accepted August 25, 2004.
1262Nilsson et al
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OBSTETRICS & GYNECOLOGY