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Int Urogynecol J (2007) 18:1015–1019

DOI 10.1007/s00192-006-0279-3

ORIGINAL ARTICLE

A randomized comparison of transobturator tape and Burch


colposuspension in the treatment of female stress urinary
incontinence
Ahmet Akin Sivaslioglu & Eray Caliskan & Ismail Dolen &
Ali Haberal

Received: 27 October 2006 / Revised: 27 October 2006 / Accepted: 16 November 2006 / Published online: 20 December 2006
# International Urogynecology Journal 2006

Abstract This study was performed to compare the in the TOT group which was similar to the 87% (p=0.9)
efficacy of transobturator tape (TOT) and Burch colposus- and 83.8% (p=0.6) in the Burch group, respectively. TOT
pension in the treatment of female stress urinary inconti- procedure results in similar cure rates of SUI at 1 and
nence (SUI). This is a prospective randomized single blind 2 years compared to Burch procedure. The TOT procedure
study of 100 women diagnosed as with urodynamic SUI has a shorter operative time and length of hospital stay.
who were randomized either to TOT procedure (n=49) or
Burch procedure (n=51). The outcome was evaluated at 1 Keywords Stress urinary incontinence .
and 2 years. The mean operation time and hospital stay Transobturator tape . Burch colposuspension
were significantly shorter in the TOT group compared to
Burch group (p<0.001). Procedure-related complications
and postoperative voiding problems including postoperative
urinary retention, de novo voiding difficulties and de novo Introduction
urge incontinence were similar in the two groups. Both the
subjective and objective cure rates of SUI at 1 year were Stress urinary incontinence affects more than one-fourth of
85.7 and 87.5%, respectively, in the TOT group. This was women between the ages of 30–60 years and stress urinary
similar to subjective and objective cure rates at one year of incontinence (SUI) constitutes about 77% of all types of
84.3% (p=0.8) and 80.3% (p=0.4) in the Burch group, incontinence [1]. Many surgical treatments have been
respectively. At the end of 2 years, 32 patients were described which aim to elevate and stabilize urethrovesical
available in the TOT group and 31 patients were available junction forming a hammock-like support under the urethra.
in the Burch group for analysis. Both the subjective and The Burch colposuspension has been considered as the gold
objective cure rates of SUI at 2 years were 87.5 and 87.5% standard for the treatment of SUI by most of urogynecol-
ogists, and therefore it is the procedure to which all other
operations for incontinence are compared in terms of
efficacy, technical difficulty, and safety [2].
A. A. Sivaslioglu (*) : I. Dolen : A. Haberal
The transobturator tape (TOT) procedure was first
Ankara Etlik Maternity and Women’s Health Teaching
and Research Hospital, introduced in 2001 by Delorme with the aim to avoid
Ankara, Turkey bladder, bowel, and major vascular injuries which had been
e-mail: aas@tr.net reported by other retropubic sling techniques [3]. When the
TOT technique is performed properly, no major neuro-
E. Caliskan
Department of Obstetrics and Gynecology, Kocaeli University, vascular complications are seen because the tape is placed
Kocaeli, Turkey reasonably far away from important structures [4]. Partic-
ularly the out–in technique has been considered to be safer
Present address:
in avoiding damage to the dorsal nerve of clitoris [5].
A. A. Sivaslioglu
Bilkent 3 Konutlari A/2 Blok No:37, Despite 5 years of experience with the TOT proce-
Ankara, Turkey dure, only a few studies have compared its efficacy with
1016 Int Urogynecol J (2007) 18:1015–1019

other sling procedures such as tension free vaginal tape Women’s Teaching Hospital between November 2003 and
(TVT) [6]. November 2005.
The TOT procedure has been gaining popularity Patients with previous incontinence surgery, urge incon-
amongst urogynecologist in the treatment of stress urinary tinence, urodynamic detrusor overactivity, or genital pro-
incontinence. In this study, we aimed to compare the TOT lapse of POP-Q stage II or more were excluded (n=67).
procedure with the Burch procedure in a randomized (Fig. 1, study flow chart).
clinical trial setting and compare their efficacy in the The study was approved by the local ethics committee
treatment of SUI. and only those women who gave written consent were
included in the study.
One hundred patients were eligible for the study.
Materials and methods Preoperative evaluation included a complete clinical histo-
ry, urogynecologic examination (stress test, Q-tip test, and
Patients who had urodynamically proven stress urinary cough stress pad test), neurological examination (clitoral
incontinence were recruited for the study from the reflex, anal reflex, and cough reflex), urinalysis and culture,
Urogynecology Department of Ankara Etlik Maternity and fasting blood glucose testing, urodynamic studies (cystom-

Assessed for eligibility


(n=167)

Excluded (n = 67)
Enrollment Not meeting inclusion criteria (n=67)
Refused to participate(n=0 )
Other reasons (n = 0 )
Randomized

Allocated to intervention (n = 49) Allocated to intervention (n= 51)


Received allocated intervention (n = 49) Allocation Received allocated intervention (n= 51)
Did not receive allocated intervention (n=0) Did not receive allocated intervention (n=0)

Lost to follow-up (n= 0 )


Lost to follow-up (n =0 ) Follow-Up
Discontinued intervention (n= 0) Discontinued intervention (n =0 )

Analyzed (n= 49 ) at one year Analyzed (n=51 ) at one year


Analyzed (n= 32 ) at two years Analysis Analyzed (n = 31 ) at two years
Excluded from analysis (n =0 ) Excluded from analysis (n=0 )
Fig. 1 Study flow chart
Int Urogynecol J (2007) 18:1015–1019 1017

etry, uroflowmetry, urethral pressure profilometry and after the operation and the patient reported the restoration
Valsalva leak point pressure), and pelvic ultrasonography. of urinary incontinence, then it was regarded as “objective
All proven urinary tract infections were treated with cure”. If the patient reported the restoration of urinary
appropriate antibiotics before surgical intervention. incontinence but the supine cough stress test was positive,
The study was a single blind randomized trial and the then it was regarded as “subjective cure”.
patients were randomly allocated to either TOT (n=49) or Our primary outcome measure was objective cure rate
Burch group (n=51). A computer-based stratified random- after 1 year of incontinence surgery. Secondary outcome
ization was generated using menopausal status as a block. measures were duration of procedures, hospital stay, and
All procedures were performed by the first author subjective cure rates at 1 year. All patients received the
(AAS). The patients were not blinded to the operative intended treatment and no protocol deviations were
procedure. Postoperative assessment was done by a senior observed.
surgeon of the urogynecology clinic who did not take part All the data were recorded using standard forms. We
in the operations. The first author was not involved in the used SPSS 11.5 (Statistical Package for Social Sciences) for
follow-up. Windows for statistical analysis. We gave the results as
The Burch procedure had been performed as described mean±standard deviation and as numbers and percents. We
by Walters et al. [7] by applying two sutures bilaterally analyzed continuous variables with Student’s t test for
using double bites for each suture. In placing the sutures, a normally distributed data and Mann–Whitney U test for
full thickness of vaginal wall was taken, excluding the skewed data. We made comparisons by chi-square test for the
epithelium, with the needle parallel to the urethra. The categorical data. For all comparisons, p<0.05 was considered
distal suture was placed 1 cm lateral to the midurethra— statistically significant.
one finger breadth—the proximal suture was placed
approximately 1 cm lateral to the reflection of the anterior
bladder wall at the level of the urethrovesical junction. On Results
each side, after the two sutures (no.1 Ethibond®) were
placed, they were then passed through the ipsilateral The groups were similar in terms of age, body mass index,
iliopectineal (Cooper’s) ligament. While tying the sutures, parity, menopausal status, hormone replacement therapy, and
a 2-cm width empty space was left between the anterior the duration of SUI (Table 1). The duration of the operation
vaginal wall and Cooper’s ligaments. was significantly shorter in the TOT group (23.2±7.1 min)
The TOT (Safyre™, Promedon) procedure was per- compared to the Burch group (46.1±7.9 min, p<0.001).
formed under spinal anesthesia. A 20-mm incision was Hospital stay was also shorter in the TOT group compared
made on the anterior vaginal wall over the miduretha. The to the Burch group (1.8 ± 1.2 vs 4.3 ± 1.8, p < 0.001,
dissection continued laterally until the index finger came in respectively) (Table 2). Operative complications including
contact with internal surface of the ischiopubic bone and bladder injury and bleeding exceeding 100 ml and
obturator foramen. A horizontal line was drawn from the postoperative urinary retention at days 1, 2, and longer
level of clitoris to the inguinofemoral sulcus on both sides. were similar in the two groups (Table 2). Postoperative
A 5-mm vertical incision was made where the line crossed urinary infection was also similar in the two groups.
the sulcusus. A curved device was introduced from this All patients were evaluated at the end of 1 year . Both
incision through the superficial aponevrosis and obturator the subjective and objective cure rates of SUI at one year
foramen in the guidance of index finger on each side. The were 85.7% in the TOT group which was similar to the
silicone arm of the polypropylene mesh was then attached
to the tip of the device and the device was withdrawn back Table 1 Patient characteristics
pulling the sling with it. The method was an outside to
inside method. The same procedure was performed on the Variable TOT (n=49) Burch P value
(n=51)
contralateral side. The mesh was placed underneath the
urethra without any tension. Age (years) 45.4±6.8 46.1±7.9 0.6
Cystoscopy was routinely performed after both proce- Body mass index (kg/m2) 29.8±5.3 29.3±7.2 0.6
dures. The Foley catheter was removed from the bladder Parity 2.6±1.1 2.4±1.5 0.4
24 h after the operations. The patient was discharged when Postmenopausal (%) 14 (28.5) 15 (29.4) 0.9
the postvoiding residual urine volume was less than 100. Hormone replacement 8 (16.3) 7 (13.7) 0.3
The postvoding residual urine volume was measured by therapy (%)
Duration of stress urinary 3.2±1.8 3.6±2.1 0.7
ultrasonography.
incontinence (years)
The patients were evaluated at 6 weeks, 6 months, 1 year
and at 2 years. If the supine cough stress test was negative Mean±standard deviation and n (%)
1018 Int Urogynecol J (2007) 18:1015–1019

Table 2 Operation duration, hospital stay, intraoperative, and post- “tape cutting” procedure was performed because the patient
operative complications was very anxious; however, she remained dry after the
Variable TOT Burch P value intervention.
(n=49) (n=51) Three patients had voiding difficulty after the Burch
colposuspension. Two of them were treated with longer
Duration of procedure (min) 23.2±7.1 48±17.4 <0.001* drainage of the bladder with Foley catheter up to 10 days.
Hospital stay (days) 1.8±1.2 4.3±1.8 <0.001*
One patient needed a “suture cutting” procedure via
Operative complications
Bladder injury 0 0 NA laparoscopy.
Bleeding exceeding 100 ml 1(2) 0(0) 0.3
Postoperative urinary retention
>100 ml at day 1 6 (12.2) 9 (17.6) 0.4 Discussion
>100 ml at day 2 4 (8.1) 6 (11.7) 0.5
>100 ml after day 2 1 (2) 3 (5.8) 0.3
To our knowledge, this is the first randomized study
Postoperative urinary infection 1 (2) 3 (5.8) 0.3
comparing the TOT with the Burch colposuspension. This
Mean±standard deviation and n (%) randomized, comparative study between TOT and Burch
*p<0.05 is statistically significant; independent samples t test. colposuspension is the first to compare the TOT technique
to the “gold standard’ operation for urodynamic stress
84.3% (p=0.8) and 80.3% (p=0.4) cure rates in the Burch urinary incontinence.
group, respectively (Table 3). Previously, Liapis et al. noted that the TOT approach had
For analysis of cure rates at the end of 2 years, 32 comparable success rates with respect to the TVT in a study
patients were available in the TOT group and 31 patients carried on 89 patients [9]. However, vaginal erosions and
were available in the Burch group (Table 3). Both the infectious complications appeared to be more common in
subjective and objective cure rates of SUI at the end of their subjects [10].
2 years were 87.5% in the TOT group which was similar to In our study, the operation time and hospital stay were
the 87% (p=0.9) and 83.8% (p=0.6) in the Burch group, about two times longer in the Burch group compared to the
respectively. TOT group but the cure rates were comparable at the end of 1
Seven patients in the TOT group were incontinent by the and 2 years. Several randomized studies have compared the
end of 1 year: medical therapy was commenced in four sling procedures (such as TVT) with Burch colposuspension
patients while three patients were reoperated on and tension [11, 12]. All these studies reported shorter operation time
free vaginal tape (TVT) procedure was performed. The and hospital stay with the various slings compared to the
TVT slings were placed without removal of the TOT sling. Burch procedure and hospitalizations were significantly
Moore et al. [8] reported successful placement of TVT sling shorter compared to the Burch [11, 13–15]. Not surpris-
after TOT failure. ingly, in this study in the TOT group, the operation time
De novo urge incontinence developed in one patient in and hospital stay were shorter compared to the Burch.
the TOT group. Ten patients were incontinent in the Burch The cure rate after Burch colposuspension is 80 to 94%
group: six patients received medical treatment while four at the end of 1 year [15, 16]. Similarly, cure rates at 1 year
patients were reoperated on with the TVT procedure. have been reported to be 84 to 95% for sling procedures
Urinary retention was observed in one patient in the [11, 16]. Similar high cure rates of 87 to 90% were reported
TOT group. Globe vesicale developed 6 h after the removal after TOT procedures [17, 18]. Our results for cure rates
of Foley catheter. Complete obstruction was noted and a with both the TOT and Burch procedures are comparable to

Table 3 Cure rates on stress


urinary incontinence (SUI) at 1 Variable TOT (n=49) Burch (n=51) P value
and 2 years and postoperative
voiding troubles Postoperative voiding troubles
De novo urge Incontinence 1 (2) 3 (5.8) 0.3
De novo voiding difficulties 1 (2) 1 (1.9) 0.9
Evaluation at 1 year TOT (n=49) Burch (n=51)
Subjective cure rates on SUI 42 (85.7) 43 (84.3 95%CI 74.4–94.2) 0.8
Objective cure rates on SUI 42 (85.7 95%CI 75.9–95.5) 41 (80.3 95%CI 69.4–91.2) 0.4
Evaluation at 2 years TOT (n=32) Burch (n=31)
Subjective cure rates on SUI 28 (87.5 95%CI 76.1–98.9) 27 (87 95%CI 75.2–98.8) 0.9
Data is presented as n (%) and Objective cure rates on SUI 28 (87.5 95%CI 76.1–98.9) 26 (83.8 95%CI 70.9–96.7) 0.6
95% confidence interval.
Int Urogynecol J (2007) 18:1015–1019 1019

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