Geburtshilfe Frauenheilkd 2018; 78(10): 210-211
DOI: 10.1055/s-0038-1671392
Poster
Freitag, 02.11.2018
Operative Gynäkologie, Urogynäkologie II
Georg Thieme Verlag KG Stuttgart · New York

Intraoperative variations of the retropubic TVT-procedure and their immediate and mid-term effects on patients' outcome. A prospective randomized controlled multicenter trial

J Marschke
1   Deutsches Beckenbodenzentrum, St. Hedwig-Krankenhaus, Urogynäkologie, Berlin, Deutschland
,
C Reisenauer
2   Universitätsklinikum Tübingen, Department für Frauengesundheit, Tübingen, Deutschland
,
T Mikkola
3   Universitätsklinikum Helsinki, Gynäkologie und Geburtshilfe, Helsinki, Finnland
,
F Schwab
4   Charité – Universitätsmedizin Berlin, Institut für Hygiene und Umweltmedizin, Berlin, Deutschland
,
R Tunn
1   Deutsches Beckenbodenzentrum, St. Hedwig-Krankenhaus, Urogynäkologie, Berlin, Deutschland
,
M Hübner
5   Lindenhofgruppe, Frauenzentrum Bern, Bern, Schweiz
› Author Affiliations
Further Information

Publication History

Publication Date:
20 September 2018 (online)

Also available at
 
 

    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

    Parameter (N = 303 total recruitment; TVT® N = 152; RetroArc® N = 151)

    3 months follow-up (Nmax = 288)

    12 months follow-up (Nmax = 229)

    TVT® (Nmax = 144)

    RetroArc® (Nmax = 144)

    p-Value*

    TVT® (Nmax = 113)

    RetroArc® (Nmax = 116)

    p-Value*

    Cure rate, % (n/N)

    93.1 (134/144)

    86.1 (124/144)

    0.054

    92.0 (103/112)

    85.8 (97/113)

    0.144

    ICIQ-UI-SF total, median (IQR)

    0 (0 – 4)

    2.5 (0 – 7)

    0.004*a

    0 (0 – 5)

    4 (0 – 8)

    0.004*a

    ICIQ-UI-SF: Leaks when you cough or sneeze, % (n/N)

    4.9 (7/144)

    16.0 (23/144)

    0.002*

    10.6 (12/113)

    26.7 (31/116)

    0.002*

    UDI-6: Leakage related to physical activity >= 2, % (n/N)

    13.2 (19/144)

    30.6 (44/144)

    < 0.001*

    23.9 (27/113)

    45.7 (53/116)

    0.001*

    Likert scale <= 1, % („much better“) (n/N)

    88.6 (117/132)

    81.8 (108/132)

    0.117

    88.5 (100/113)

    79.3 (92/116)

    0.059

    Ultrasound – sling rolled up (C-shaped), % (n/N)

    2.8 (4/144)

    11.8 (17/144)

    0.003*

    3.6 (4/112)

    13.4 (15/112)

    0.008*

    Distance Tape Urethra (mm), median (IQR)

    6.3 (5.2 – 7.2)

    6 (5 – 7)

    0.015*a

    5.7 (5 – 7)

    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%)

    Conclusions:

    Both methods result in excellent 12-month cure-rates. The variations tested suggest positioning the tape with filled bladder is viable.


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