Objective:
To analyze two different surgical techniques and differently manufactured polypropylene-tapes regarding postoperative cure-rates and perioperative complications.
Materials/Methods:
The TVT®-group was operated (empty bladder, straight inserter) as instructed, the RetroArc®-group without inserter, filled bladder (200 ml). Primary endpoint: cough-test standing (CTS) with filled bladder (200 ml), supine empty-stress-test (SEST), UDI-6, ICIQ-UI-SF. Cure-rate: negative SEST, CTS, subjective parameters. Secondary endpoints: mean operating time and blood-loss, ultrasound criteria (tape's morphology, urethral distance).
Results:
Mean operating time was 20 min (median, IQR: 10 – 36) in the TVT®-Group and 20 min (IQR 10 – 40) in the RetroArc®-Group (p = 0.328). Mean blood loss was < 50 ml in 98% (n = 144/148 TVT®) vs. 100% (n = 151 RetroArc®, p = 0.083). N = 3 patients required surgical intervention for retropubic hematoma (n = 1 TVT®, n = 2 RetroArc®, p = 0.554), One patient had a bladder perforation (RetroArc®-group), p = 0.315. In n = 7 patients in the RetroArc®-group surgeons described difficulties in application (TVT®-group: 0, p = 0.007).
Tab. 1
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Parameter (N = 303 total recruitment; TVT® N = 152; RetroArc® N = 151)
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3 months follow-up (Nmax = 288)
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12 months follow-up (Nmax = 229)
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|
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TVT® (Nmax = 144)
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RetroArc® (Nmax = 144)
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p-Value*
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TVT® (Nmax = 113)
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RetroArc® (Nmax = 116)
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p-Value*
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Cure rate, % (n/N)
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93.1 (134/144)
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86.1 (124/144)
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0.054
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92.0 (103/112)
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85.8 (97/113)
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0.144
|
|
ICIQ-UI-SF total, median (IQR)
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0 (0 – 4)
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2.5 (0 – 7)
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0.004*a
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0 (0 – 5)
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4 (0 – 8)
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0.004*a
|
|
ICIQ-UI-SF: Leaks when you cough or sneeze, % (n/N)
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4.9 (7/144)
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16.0 (23/144)
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0.002*
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10.6 (12/113)
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26.7 (31/116)
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0.002*
|
|
UDI-6: Leakage related to physical activity >= 2, % (n/N)
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13.2 (19/144)
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30.6 (44/144)
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< 0.001*
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23.9 (27/113)
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45.7 (53/116)
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0.001*
|
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Likert scale <= 1, % („much better“) (n/N)
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88.6 (117/132)
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81.8 (108/132)
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0.117
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88.5 (100/113)
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79.3 (92/116)
|
0.059
|
|
Ultrasound – sling rolled up (C-shaped), % (n/N)
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2.8 (4/144)
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11.8 (17/144)
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0.003*
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3.6 (4/112)
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13.4 (15/112)
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0.008*
|
|
Distance Tape Urethra (mm), median (IQR)
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6.3 (5.2 – 7.2)
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6 (5 – 7)
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0.015*a
|
5.7 (5 – 7)
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5.95 (5 – 7)
|
0.863a
|
|
Results: *p-value, chi-square test if no other indicated; a Wilcoxon-ranksum test; b Fisher's exact test; IQR, interquartile range: (25%-75%)
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Conclusions:
Both methods result in excellent 12-month cure-rates. The variations tested suggest positioning the tape with filled bladder is viable.
