1. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial
MARTIN RUDNICKI1, KATARINA VON BOTHMER-OSTLING2, ANJA HOLSTAD3, CLAES MAGNUSSON4, MEMONA MAJIDA5, CONSTANZE MERKEL6,
JENS PRIEN7, ULF JAKOBSSON8 & PIA TELEMAN9
1Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark, 2Department of Obstetrics and Gynecology, Halmstad Hospital, Halmstad, Sweden, 3Department of Obstetrics and Gynecology, Gjøvik Hospital, Gjøvik, Norway, 4Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden, 5Department of Obstetrics and Gynecology, Ahus University Hospital, Oslo, Norway, 6Department of Obstetrics and Gynecology, Regional Hospital of Northern Jutland, Frederikshavn, Denmark, 7Department of Obstetrics and Gynecology, Zealand Hospital, Nykøbing Falster, Denmark, 8Center for Primary Healthcare Research, Faculty of Medicine, University of Lund, Lund, Sweden, and 9Department of Obstetrics and Gynecology, Skane University Hospital, Lund University, Lund, Sweden
ACTA Obstetricia et Gynecologica Scandinavica Journal Club
-Gynecology-
November 2017
Edited by Francesco D’Antonio

2. Introduction
Surgical treatment for urinary incontinence has changed considerably during recent decades.
Currently, minimal invasive mid-urethral sling procedure under local anesthesia represents the standard surgical procedure for this condition, with a cure rate up to 90%.
Since its introduction, the standard mid-urethral retropubic sling (SMUS) has been modified by using a transobturator approach. The main reason for such change was the higher rate of bladder perforation using the retropubic route.
Single-incision mid-urethral sling (SIMS) was assumed to solve some of the complications associated with traditional slings, and it has been shown to be associated with a shorter operation time, reduced blood loss and fewer complications and that it can be done under local anesthesia.
The technique of the adjustable SIMS Ajust procedure is close to that of the SMUS procedures and, similar to these slings, the tension of the sling can be adjusted during the procedure.

3. To report pain perception and complications at the one year follow up
Aim of the study
To compare the objective and subjective outcomes and short-term complication rates of an adjustable single incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS)
and
To report pain perception and complications at the one year follow up

4. Material and Methods
Study design: Prospective multicenter randomized trial comparing Ajust (C.R. Bard Inc., Murray Hill, NJ, USA) with TVT (Ethicon Inc, Somerville, NJ, USA), TVT-O inside-out (Ethicon Inc) or transobturator tape (TOT) (Monarc AMS, MN, USA) as preferred by the eight local centers in Denmark, Norway and Sweden.
Inclusion criteria: Women with a medical history of stress or mixed urinary incontinence defined as the complaint of involuntary leakage associated with urgency and stress incontinence. Stress urinary incontinence was confirmed by a positive standardized cough test including 300 cm 3 in the bladder and had failed or declined pelvic floor muscle training.
Exclusion criteria: Age >60 years, predominant urge incontinence, pelvic organ prolapse (Pelvic Organ Prolapse Quantification ≥stage 2), previous incontinence or pelvic organ prolapse surgery, planned or present pregnancy, residual urine volume >100 mL, previous pelvic irradiation, repeated urinary tract infections (four or more during the past year), neurological conditions such as multiple sclerosis, current treatment with corticoids, inability to understand the protocol, and a history of genital or abdominal cancer or a pelvic mass.

5. Material and Methods
Primary outcome: To compare the objective and subjective outcomes and short-term complication rates of an adjustable singleincision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS).
Secondary outcome: Pain perception (VAS score) and complications incurred at one-year follow up.
Surgery: Ajust utilizes a small sub-urethral incision similarly to mid-urethral slings. The mesh is anchored in the obturator membrane on both sides, and then adjusted similarly to the mid-urethral sling methods. Cystoscopy was performed during the surgical procedure in all cases.
The other avalaible slings (TOT or TVT-O) are either placed slimilarly as Ajust, but pulled through the skin for adjustment at the thight or placed retropubic (TVT) through the abdominal skin for adjustment.

6. Material and Methods Pre and post-surgical assessment:
Preoperative assessment included women’s medical history and physical examination, as well as questionnaires including pain diary.
The same questionnaires were submitted 3 months after surgery.
All women were invited to a one-year follow up, which included physical examination, a stress test (300 mL in the bladder), assessment of post-voiding residual volume and answering questionnaires.
The International Consultation on Incontinence Questionnaire (ICIQ-SF-UI), Patient Global Impression of Improvement (PGI-I) (and Patient Global Impression of Severity (PGI-S), and, if sexually active, the Pelvic Organ Prolapse/Urinary incontinence Sexual Questionnaire (PISQ-12) were used to evaluate the influence of surgery on incontinence, quality of life and the women’s perception of improvement.
Postoperative pain was recorded a fixed time daily using a 10-point visual analogue scale (VAS 0–10) during a sixday period.

7. Material and Methods
Statistical analysis: Data were presented as median interquartile range when not normally distributed (Shapiro–Wilcoxon test). Analysis was done by intention-to-treat regulations and imputation was done using multiple imputations on the main outcome for participants who were last at follow up. For nominal data we used Fisher’s exact test and Chisquare test; for ordinal and non-normally distributed data we used Mann–Whitney U-test or Friedman’s test for comparisons between groups. The Wilcoxon sign-rank test served as a post-hoc test to the Friedman’s test. A reduced p-value (Bonferroni method) was used to control for the risk of mass significance. Relative risks were calculated to compare the efficacy of the two groups.

8. Results
305 women fulfilled the inclusion criteria (155 received Ajust and 150 the SMUS: TVT, n = 83; TVTO, n = 13; TOT, n = 54).

9. Results
General patients’ characteristics did not differ between the two groups.
Baseline bladder function was equal in both groups.

10. Results
No difference between the groups regarding the number of days analgesics were taken.
However, a significantly lower number of women experienced pain on day 6 following surgery in the Ajust group (24%) than in the SMUS group (43%), p <

11. Results
At the 3-month follow up, one Ajust and one sling in the SMUS group (TVT) had been cut due to retention and severe urgency, respectively. Other complications were minor and no difference was observed between the groups.
One-year control demonstrated an equal objective cure rate in both groups (Table 5), although lower compared with the subjective cure rate (ICIQ-UI-SF).
The ICIQ score sum was reduced equally in both groups compared with inclusion values.
“Zero incontinence” episodes were more frequently recorded in bladder diaries than was “never incontinent” in ICIQ-UI-SF (83.3–88.9% vs. 50.7–60.0%.

12. Results
The percentage of women reporting “significantly improved” and “much improved” was 92.4% in the Ajust group and 93.0% in the SMUS groups (p = 0.800). Similarly, the PGI-S declined simultaneously in both groups without any difference between the groups at the one-year follow up.
There was no difference between the two groups regarding objective [RR 0.938, 95% confidence interval (CI) 0.705–1.249, p = 0.691; no leakage vs. leakage] and subjective cure rate (RR 0.88; 95% CI , p = 0.627; never leakage vs. any leakage).
The rate of dyspareunia was low and there was no difference between the groups

13. Limitations
The length of the follow-up was only 12 months. Several studies have demonstrated the durability of TVT although the cure rates have been shown to decrease with time. Thus, a one-year follow-up is not sufficient to make any safe conclusion regarding the efficacy and safety of Ajust®.
The study includes different types of slings in the SMUS group. Although this refer to the general use of slings, this may blur any difference otherwise detected.
Pain perception is difficult to record and bias may appear since not all prescribed medication is recorded.

14. Conclusion
Compared with SMUS, Ajust appears to be associated with similar objective and subjective success rates and less pain perception following surgery.