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.