SELF-REPORTED
URINARY CONTINENCE OUTCOMES FOR REPEAT MIDURETHRAL SYNTHETIC SLING PLACEMENT
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JONATHAN A. EANDI,
STACY T. TANAKA, NICHOLAS J. HELLENTHAL, R. COREY O’CONNOR, ANTHONY
R. STONE
Department
of Urology (JAE, STT, NJH, ARS), UC Davis Medical Center, Sacramento,
California, and Department of Urology (RCO), Medical College of Wisconsin,
Milwaukee, Wisconsin, USA
ABSTRACT
Objective:
To evaluate our experience with tension-free transvaginal tape (TVT) placement
for the management of stress urinary incontinence (SUI) in women who had
previously undergone a failed midurethral synthetic sling (MUS) procedure.
Materials and Methods: Ten women underwent
retropubic TVT insertion for continued or recurrent SUI following a prior
MUS procedure. No attempt was made to remove the previously placed sling
at the time of surgery. A retrospective chart review was performed to
obtain perioperative and follow-up patient information. Post-operatively,
each patient completed a mailed incontinence questionnaire to assess self-reported
urinary continence outcomes.
Results: All 10 women were available for
follow-up at a mean period of 16 months (range 6 to 33). Four of the 10
patients achieved complete continence, and another three patients reported
significantly improved continence and quality of life. Three women stated
that their continence did not improve.
Conclusions: TVT placement may be a viable
option for the management of women with persistent or recurrent SUI following
an initial MUS procedure.
Key
words: female; urinary incontinence; stress urinary incontinence;
prostheses and implants; slings
Int Braz J Urol. 2008; 34: 336-44
INTRODUCTION
Tension-free
transvaginal tape (TVT) is one of the preferred therapeutic approaches
for the treatment of female stress urinary incontinence (SUI). It is considered
a minimally invasive yet effective surgical method for the management
of SUI. Recently published TVT surgical results show a high success rate
ranging from 80-95% with greater than five year follow-up (1-4). However,
5-20% of treated patients experience surgical failure with clinically
significant recurrent or persistent SUI (1-3).
To date, no consensus exists for the management
of SUI in women with a previous failed midurethral synthetic sling (MUS)
procedure. Several possible treatment options have been described in the
literature. These include pelvic floor rehabilitation, placement of an
artificial urinary sphincter (5,6), periurethral injection of bulking
agents (6), or most commonly a more invasive anti-incontinence surgery
such as colposuspension or suburethral sling (6-8). Recently, some authors
have advocated transvaginal shortening or tightening of the implanted
tape for recurrent or persistent SUI after MUS (9-12). Another option
is to perform a repeat MUS. However, there is a paucity of published data
on repeat MUS procedures for the management of persistent or recurrent
SUI (10,13-16).
We describe our experience with retropubic
TVT placement for the management of SUI in women with a previous failed
MUS procedure. In this study we utilized a patient self-reported quality
of life questionnaire to assess the efficacy of the procedure. To our
knowledge, this is the first study to present data using a validated incontinence
questionnaire to assess outcomes for TVT insertion following an unsuccessful
MUS procedure.
MATERIALS
AND METHODS
Following
institutional review board approval, a retrospective chart review was
performed to identify women that underwent placement of a TVT due to primary
or recurrent failure of a MUS surgery for the management of SUI. A total
of ten women (mean age 65 years, range 43 to 80) underwent retropubic
TVT insertion at our institution between January 2004 and June 2006 following
failure of a previously placed MUS. All procedures were performed by,
or under the guidance of one experienced pelvic surgeon (A.R.S.). Preoperative
evaluation included previous medical history, physical examination, urinalysis,
urine culture, and video urodynamic evaluation. No patient had evidence
of tape extrusion or erosion. Post-operatively, each participant received
a telephone call from a non-biased third party informing them of the study
prior to mailing of the International Consultation on Incontinence Questionnaire
(ICIQ) (Appendix-1) (16). The questionnaires were accompanied by an informed
consent as well as a brief outline describing the objective of the study.
All ten patients completed and returned the consent and questionnaire
forms. Complete continence was defined by a sum score of zero on the ICIQ.
In other words, the patient was required to self-report total absence
of urinary leakage to qualify as completely continent. We defined a score
of 0 or 1, on a scale from 0 to 10, on question 3 of the ICIQ to indicate
that urine leakage no longer impacted the patient’s quality of life.
We have occasionally used periurethral bulking
agents after TVT failure, however this paper focuses on those patients
who underwent repeat TVT.
Retropubic midurethral synthetic sling placement
was performed using the Gynecare (Ethicon, Somerville, NJ) TVT device.
No attempt to locate or alter the previously placed sling was made at
the time of surgery.
RESULTS
Placement
of the TVT was performed in 10 patients following an initial unsuccessful
MUS procedure (Table-1). The interval between the first MUS and second
TVT procedure ranged from three to 32 months (average 14). All 10 women
were available for follow-up at a mean period of 16 months (range 6 to
33). Five women underwent previous retropubic MUS, or TVT. The remaining
five patients underwent a prior transobturator tape (TOT), including four
using the in-to-out technique and one using the out-to-in method. Four
patients underwent incision or removal of the initial MUS for voiding
dysfunction. Three of these women had previously undergone TVT, the other
underwent TOT, and required clean intermittent catheterization following
the first procedure.
All ten patients demonstrated urodynamic
evidence of SUI following original MUS placement prior to undergoing the
second TVT procedure. The Valsalva leak point pressure was < 60 cm
H2O
in three women. None had significant detrusor overactivity, although anticholinergics
were used for subjective urgency. Physical examination confirmed the presence
of genuine stress incontinence in all patients. All had some degree of
urethral hypermobility.
At the time of TVT insertion, two women
underwent concurrent procedures. One patient required anterior repair
with porcine graft, while another underwent posterior repair. Both patients
were discharged home on post-operative day one without a catheter in place.
The eight patients who underwent TVT placement alone were all discharged
home on the same day of surgery. Average blood loss and operative time
for these eight patients was 10 mL (range 5 to 20) and 30 minutes (range
24 to 42), respectively. Including the two women who underwent additional
surgery (one anterior repair, one posterior repair), the mean blood loss
and operative time for all ten patients was 22 mL and 50 minutes, respectively.
No intraoperative or immediate postoperative complications occurred for
any patients.
All 10 women completed the mailed ICIQ (Table-2).
Four of the 10 (40%) patients achieved complete urinary continence indicated
by a sum score of 0 for the ICIQ. Seven of the 10 women (70%) self reported
a score of either 0 or 1 on question 3 of the ICIQ, thereby indicating
that urine leakage no longer impacted their quality of life. Three patients
were not significantly improved by their second procedure.
All three women that did not improve with
TVT placement were immediate failures, exhibiting SUI following the initial
procedure. Therefore, none of the three patients required incision or
removal of the initial midurethral synthetic sling material.
Three of the ten patients use anticholinergics
for overactive bladder-type symptoms. Each indicated on the incontinence
questionnaire that urine leaks prior to getting to the toilet. However,
all three women used anticholinergics prior to the TVT insertion, indicating
that the second procedure did not result in de novo detrusor overactivity.
Only one patient had difficulty with bladder
emptying after her second surgery. She underwent midurethral sling lysis
following her initial TVT due to urinary retention. However, after initial
TVT takedown her urinary incontinence was severe and adversely impacted
her quality of life. The patient elected to undergo repeat TVT with the
understanding that, as her preoperative urodynamics had suggested inefficient
voiding, and may require CIC. Following the repeat TVT, the patient experienced
no urinary leakage and indicated satisfaction with the outcome despite
the need to perform CIC.
COMMENTS
Placement
of a midurethral synthetic sling has become one of the preferred therapeutic
modalities for the surgical management of female SUI. Despite reports
of excellent outcomes with TVT placement, some women continue to experience
persistent or develop recurrent SUI (1-3). The etiology of persistent
or recurrent SUI following TVT is not well defined. Some theorize that
the initial placement of the tape was too loose or positioned incorrectly,
thereby preventing functional urethral kinking to occur during periods
of increased abdominal pressure (17). Riachi et al. proposed that inappropriate
intraoperative adjustment of the tape, failure of the tape to be fixed
in place, or that the underlying pathology of the urinary incontinence
mechanism was responsible for persistent SUI following TVT (13).
There are several surgical treatment choices
for the management of SUI following a failed MUS procedure. Such options
include placement of an artificial urinary sphincter (5,6), injection
of periurethral bulking agents (6), or traditionally a more invasive anti-incontinence
procedure such as colposuspension or placement of a suburethral sling
(6-8). More recently some authors have advocated possible salvage options
following a failed MUS procedure. These maneuvers include transvaginal
shortening or readjustment of the implanted tape (9-12). Lo et al. presented,
to our knowledge, the largest reported case series for treatment of recurrent
SUI after a TVT procedure by shortening the pre-implanted tape under local
anesthesia. Using this method they report a greater than 70% subjective
and objective cure rate in 14 women (9). The main limitation of this technique,
however, is the need to identify and dissect the tape free from adherent
periurethral tissue. For example, Tsivian et al. reoperated on 12 women
for SUI following failed MUS placement. During the surgery, the prior
MUS could not be found in three women, and was embedded and unable to
be dissected free in another (14). Similarly, Riachi et al. could not
identify the previously placed tape in 1 of 2 women undergoing reoperation
for recurrent SUI following an initial TVT procedure (13), and Villet
et al. reported the failure to locate the previously placed synthetic
sling in 1 of 3 women (10). If the tape was initially placed incorrectly,
shortening would not improve the results. Therefore, despite the apparent
efficacy of the transvaginal TVT tape shortening procedure for recurrent
SUI, it requires the identification and subsequent periurethral dissection
of the previously placed tape, which may prove to be difficult. We made
no attempt to locate or alter the previously placed tape in our patients
in order to minimize the periurethral dissection.
Another option for surgical management of
a failed MUS procedure is to repeat the procedure, thereby eliminating
any manipulation of the previously placed tape. Riachi et al. first described
repeat application of a TVT in two patients at 8 and 9 months after the
initial procedure. Both women were completely continent at 6 and 13 month
follow-up (13). Villet et al. reported on two patients who underwent repeat
TVT, no complications were reported and each woman was continent at four
and 12 months of follow-up (10). In addition to these case reports, Tsivian
et al. presented a case series of 12 women who underwent repeat MUS for
persistent or recurrent SUI following a previous MUS procedure. They report
that 11 of 12 patients achieved full continence following repeat surgery.
Interestingly, five patients underwent repeat TVT, four underwent intravaginal
sling, and three underwent TOT placement. Unfortunately the authors did
not utilize urodynamic evaluation nor present their telephone acquired
questionnaire results for post-operative objective or subjective assessment
(14). Recently, Moore et al. reported on the successful treatment of five
women with recurrent SUI using a TVT following a failed prior TOT insertion
(15).The largest series of repeat TVT has been reported by Lee et al.
(16), who report similar results. They used both retropubic and transobturator
approaches and noted significantly better cure rates with the retropubic
approach.
In our series, 10 women underwent retropubic
TVT for the management of SUI following a failed previous MUS procedure.
Using the ICIQ, four women (40%) reported complete urinary continence,
whereas another three women (30%) reported significant improvement in
their quality of life. Three women did not improve following repeat TVT
placement. The average age of these three women was 12 years greater than
the four patients who became completely continent following repeat TVT,
and two of the three women exhibited VLPP < 60 cm H2O
on preoperative video urodynamic evaluation. The results in this subset
of patients are not surprising since patients with low VLPP have been
shown to demonstrate lower cure rates following MUS procedures than patients
with VLPP > 60 cm H2O
(18,19). Moreover, elderly patients have been shown to report decreased
improvement following anti-incontinence procedures when compared to a
younger cohort undergoing comparable surgeries (20).
Further analysis of the data showed no substantial
difference in outcome between the five patients who underwent initial
TOT in comparison to the five patients who had initial TVT placement.
For those women with initial TOT placement, subsequent TVT resulted in
two of the five becoming completely continent and three of the five indicating
that urine leakage no longer impacted their quality of life. Similarly,
for the patients who underwent TVT placement a second time, two became
completely continent and four expressed that urine leakage no longer impacted
their quality of life. The number of cases is too small to make definitive
conclusions or meaningful statistical analysis.
All four of the patients who had undergone
tape incision, did well, two were completely dry and two had minimal unbothersome
leakage.
Advantages for performing TVT following
a previously unsuccessful MUS include its minimally invasive nature, rapid
patient recovery, and reported efficacy. As compared to transvaginal retensioning
of the previously placed tape, repeat TVT insertion does not require identification
of the initial sling material, thereby eliminating the need for any further
periurethral dissection. In addition, our findings do not suggest any
increased risk of surgical complications (difficulty with needle passage,
bladder injury, erosion) when performing TVT placement after a prior unsuccessful
MUS procedure. Although a questionnaire was not completed pre-operatively
for comparison, the combination of urodynamically demonstrated SUI and
the patient’s desire to undergo repeat surgery indicates that urinary
incontinence substantially impacted their quality of life at that time.
A limitation of this study is the lack of objective data such as a pad
test. However, we treat patients because they believe they have failed
their prior management, not because we think they have failed. We therefore
contend that patient-reported outcomes are the most important tool in
which to assess the efficacy of this treatment.
CONCLUSIONS
We
present a case series advocating application of the TVT for treatment
of recurrent or persistent SUI following an unsuccessful prior MUS. Such
an intervention could avoid the more extensive scarring, bleeding and
perioperative complications associated with more invasive procedures and
does not require additional periurethral dissection for identification
of the previously placed material. Despite the short-term follow-up and
small sample size, the results of our study suggest that TVT insertion
may be a viable option for the management of failed previous MUS procedures.
Further studies with longer follow-up and more patients are necessary
to identify the best option for management of recurrent or persistent
SUI following a previous MUS procedure.
CONFLICT
OF INTEREST
None
declared.
REFERENCES
- Merlin T, Arnold E, Petros P, MacTaggart P, Tulloch A, Faulkner K,
et al.: A systematic review of tension-free urethropexy for stress urinary
incontinence: intravaginal slingplasty and the tension-free vaginal
tape procedures. BJU Int. 2001; 88: 871-80.
- Lo TS: Tension-free vaginal tape procedures in women with stress
urinary incontinence with and without co-existing genital prolapse.
Curr Opin Obstet Gynecol. 2004; 16: 399-404.
- Nilsson CG, Falconer C, Rezapour M: Seven-year follow-up of the tension-free
vaginal tape procedure for treatment of urinary incontinence. Obstet
Gynecol. 2004; 104: 1259-62.
- Tsivian A, Mogutin B, Kessler O, Korczak D, Levin S, Sidi AA: Tension-free
vaginal tape procedure for the treatment of female stress urinary incontinence:
long-term results. J Urol. 2004; 172: 998-1000.
- Elliott DS, Barrett DM: The artificial urinary sphincter in the female:
indications for use, surgical approach and results. Int Urogynecol J
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- Schulz JA, Drutz HP: The surgical management of recurrent stress
urinary incontinence. Curr Opin Obstet Gynecol. 1999; 11: 489-94.
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incontinence: A 12-year experience. Am J Obstet Gynecol. 1999; 181:
1296-307; discussion 1307-9.
- Petrou SP, Frank I: Complications and initial continence rates after
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- Lo TS, Wang AC, Liang CC, Long CY, Lee SJ: Treatment for unsuccessful
tension-free vaginal tape operation by shortening pre-implanted tape.
J Urol. 2006; 175: 2196-9; discussion 2199-200.
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tension-free vaginal tape procedure and mesh retensioning: two possibilities
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after a primary tension-free vaginal tape procedure. Int Urogynecol
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- Neuman M: Trans vaginal tape readjustment after unsuccessful tension-free
vaginal tape operation. Neurourol Urodyn. 2004; 23: 282-3.
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vaginal tape for the treatment of recurrent incontinence. J Urol. 2004;
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- Riachi L, Kohli N, Miklos J: Repeat tension-free transvaginal tape
(TVT) sling for the treatment of recurrent stress urinary incontinence.
Int Urogynecol J Pelvic Floor Dysfunct. 2002; 13: 133-5; discussion
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AA: Redo midurethral synthetic sling for female stress urinary incontinence.
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recurrent stress incontinence after transobturator tape sling failure.
Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18: 309-13.
- Lee KS, Doo CK, Han DH, Jung BJ, Han JY, Choo MS: Outcomes following
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procedure: rediscovery of the tension-free vaginal tape procedure. J
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- O’Connor RC, Nanigian DK, Lyon MB, Ellison LM, Bales GT, Stone
AR: Early outcomes of mid-urethral slings for female stress urinary
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____________________
Accepted after revision:
March 21, 2008
_______________________
Correspondence address:
Dr. Jonathan A. Eandi
Department of Urology
UC Davis Medical Center
4860 Y Street, Suite 3500
Sacramento, CA, 95817, USA
Fax: + 1 916 734-8094
E-mail: jonathan.eandi@ucdmc.ucdavis.edu
EDITORIAL COMMENT
With
current understanding of pathophysiology of stress urinary incontinence
(SUI), integral mid-urethra theory explains most of its occurrence and
has enabled successful introduction of minimally invasive mid-urethral
tension-free tapes with success rates over 80%. However, pathophysiology
of the unfortunate 20% patients who failed the initial surgery needs attention.
The factors for recurrence include, not exclusively, so-called intrinsic
sphincter deficiency (ISD) of varied etiology, voiding dysfunction and
overactive bladder, and have a great bearing on further management as
well as counseling of these low-on-self esteem patients. This underscores
the importance of detailed evaluation of these patients before planning
surgical management.
The present study is a retrospective analysis
of 10 cases with recurrent SUI following midurethral sling (TVT / TOT)
and presents encouraging results of TVT in this subgroup. I would congratulate
the authors for performing a detailed preoperative evaluation of all these
patients including clinico-urodynamic evaluation, appropriate management
of overactive bladder and adequate counseling (which led to a satisfied
patient even on CIC). Management of recurrent SUI is not standardized
and the authors are justified in their approach due to minimally invasive
nature of the procedure. TVT has been reported as a viable treatment option
for recurrent SUI after MUS as well as other surgical procedures.
Apart from the main conclusion, there are
various ‘hidden’ important results in this article which need
emphasis and are worthy of further investigations. ISD is a well known
subgroup of SUI and is vaguely defined as severe incontinence, absence
of urethral hypermobility (UH), open bladder neck (resulting from previous
surgery, radiotherapy, old age, etc.), Valsalva leak point pressure <
60 cm H2O
and maximal urethral closure pressure < 20 cm H2O.
There are several reports to suggest lower, though clinically significant,
success rates of MUS (especially TOT) in these patients more so in absence
of UH. In the present study, two of three women who failed the repeat
procedure had a Valsalva leak point pressure < 60 cm H2O;
it would be interesting to know degree of hypermobility and preoperative
degree of incontinence in these patients. Although far from standard,
it seems plausible to opt for some alternative form of treatment, e.g.
injection therapy or compressive slings at bladder neck level in case
of more than one ‘risk factors’ of ISD, especially absence
of UH.
Voiding dysfunction (VD) has been reported
to be more common after TVT than TOT, though the data on latter is limited.
Four of the 10 analyzed patients had had release of tape for voiding dysfunction
leading to recurrent SUI; interestingly 3 of these had undergone TVT,
and one TOT. It would be desirable to report the incidence of VD after
each procedure in their experience. Furthermore, pre-existing voiding
dysfunction and urethral relaxation voiding patterns (with detrusor pressure
< 12 cm H2O)
have been reported to be risk-factors for postoperative urinary retention
and need for release of sling after TVT. Therefore, it would be worthwhile
to report voiding function and voiding mechanism in these women.
I believe we have reached a stage where
our focus should shift to standardizing the management of recurrent SUI.
A practical approach to produce preliminary guidelines would be to perform
some sort of meta-analysis of the existing case series and then to formulate
plans of prospective randomized trials comparing various strategies.
Dr.
Mayank Mohan Agarwal
Dr. Ravimohan Mavuduru
Section of Urology
Postgraduate Institute of Medical Education and Research
Chandigarh, India
E-mail: drmayank_22@yahoo.co.in
EDITORIAL COMMENT
The
authors present their experience with redo tension -free transvaginal
tape placement for the management failed midurethral sling (MUS). MUS
procedure has gained wide acceptance for the treatment of female urinary
stress incontinence. However, failure rate ranges between 5 to 20 % (ref
.3,4 of the reviewed manuscript) and with the widespread use of this technique,
the practicing surgeon will encounter a considerable number of failures.
What should be the optimal management of
MUS failure? There is scarce data in the literature, therefore, in spite
of the small series and short-term follow up, lack of objective data (physical
exam, stress test, pad test etc) presented herein, this manuscript offers
well-timed and important contribution in data accumulation and improvement
of our understanding in resolving this problem.
One should note, that the preoperative work-up
of MUS failure should include cystoscopy to exclude tape erosion into
the bladder or/and urethra, especially in patients with irritative voiding
symptoms.
Additional, well designed comparative studies
are warranted to answer questions such as optimal timing of the salvage
procedure, and whether repeat MUS should be applied or different approach
is appropriate, and if MUS is chosen what is the preferred route, -transobturator
or retropubic?
Dr.
Alexander Tsivian
Department of Urologic Surgery
The E. Wolfson Medical Center, Holon
Sackler Faculty of Medicine, Tel Aviv University
Tel Aviv, Israel
E-mail: atsivian@hotmail.com |