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doi:10.1111/jog.12493
J. Obstet. Gynaecol. Res. Vol. 41, No. 1: 127–131, January 2015
Randomized prospective study comparing Monarc and Miniarc suburethral slings Andrew Foote1,2 1
Calvary Hospital, and 2Australian National University, Canberra, Australian Capital Territory, Australia
Abstract Aim: Recently a miniature version of the Monarc suburethral sling has been introduced. This paper aims to evaluate the postoperative recovery, effectiveness and complications of these two types of suburethral sling. Methods: This was a prospective randomized series of 50 female patients with stress incontinence who underwent either a Monarc or Miniarc suburethral sling. Results: The only significant intraoperative difference was a shorter operation time for the Miniarc (18.8 vs 22.4 min). The success rates were similar at 6 weeks and 6 months. Conclusion: There were no significant differences between the Miniarc and Monarc, except for a significantly shorter Miniarc sling operating time. Key words: female urinary incontinence, prospective randomized trial, suburethral sling.
Introduction Female stress urinary incontinence is defined as the involuntary loss of urine on effort or physical exertion. Prior to the 1990s, surgical treatment was a major procedure, performed via a significant lower abdominal skin incision and the placement of bladder elevating sutures or a fascial sling under the urethra. The minimally invasive synthetic retropubic suburethral sling was first described in 1995.1 A transobturator approach was introduced in 2001.2 A miniature sling was introduced in 2007,3 thence the Miniarc sling in 2008. An initial trial of 33 cases4 has reported a success rate of 95% at 6 weeks, with a decrease in postoperative discomfort and voiding dysfunction. This paper primarily aims to evaluate the postoperative short-term recovery after sling surgery, and in particular the pain scores and time to recover. It was hypothesized that the single Miniarc incision would cause less pain than the three incisions used in the Monarc procedure. Secondary outcome studies were
the effectiveness and complications of these two types of suburethral sling.
Methods This was a randomized prospective trial of 50 women with stress urinary incontinence. All patients were evaluated with history, examination, bladder diary, Incontinence Impact Questionnaire (IIQ), visual analog scale (VAS) of subjective urinary incontinence bother and urodynamics. Twin-channel urodynamics were performed evaluating filling, presence of any incontinence and voiding. Ultrasound assessment was performed of the bladder neck. A 1-h pad test was also performed with a standard set of exercises conducted after drinking 500 mL of water. Included in this study were women with urodynamically proven genuine stress incontinence, no previous retropubic incontinence surgery, no allergy to polypropylene, no significant voiding difficulty, fit for surgery, no other vaginal surgical procedures being performed concurrently and able to
Received: February 20 2014. Accepted: May 7 2014. Reprint request to: Dr Andrew Foote, 9/3 Sydney Avenue, Barton, Canberra, ACT 2600, Australia. Email: [email protected]
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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A. Foote
Flow Diagram Enrollment
Assessed for eligibility (n=61) Excluded (n= 11) ♦ Not meeting inclusion criteria (n= 9) ♦ Declined to participate (n= 2) Randomized (n= 50)
Allocation Allocated to Monarc intervention (n= 25) ♦ Received allocated intervention (n= 25)
Allocated to Miniarc intervention (n= 25) ♦ Received allocated intervention (n= 25) Follow-Up 6months
Lost to follow-up (n= 0)
Lost to follow-up (n= 0)
Analysis Analysed (n= 50) ♦ Excluded from analysis (n= 0)
Analysed (n= 50) ♦ Excluded from analysis (n= 0)
Figure 1 Study flow.
complete the study questionnaires. Sixty-one patients were invited to participate, however, 11 did not enroll in the trial (Fig. 1). All surgeries were performed by the author, or under his direct supervision of registrars. Both procedures were performed under general anesthesia. The obturator Monarc sling was inserted via two 5-mm labia majora incisions and one 10-mm anterior suburethral vaginal incision using the Monarc introducers. The Miniarc prolene sling was inserted via a single anterior vaginal incision (1 cm) and the prolene anchors attached to the left and right obturator fascia. For both procedures, tension was corrected so that no leakage was demonstrated with suprapubic pressure with the bladder filled to 300 mL. Check cystoscopy was performed, and the patient discharged upon voiding with a residual of less than 100 mL on bladder scan and a pain score of less than 5.
128
Short-term outcome measures assessed were operative time, estimated blood loss, hours in hospital, 4-h VAS pain score with no postoperative parenteral analgesia. Fentanyl 100 mg was able to be given intraoperatively if required.
Follow-up Follow-up was at 6 weeks and 6 months to determine objective surgical success by pad testing and questionnaires. Success was defined as a 1-h pad test weighing 1 g or less. Other evaluation at these visits was by examination with a full bladder, history of any urinary symptoms (incontinence, urgency, voiding difficulty), VAS, IIQ short questionnaire and bladder diary. Statistical power calculation estimated that 50 patients would provide a more than 90% power to detect a 20% difference in the effect of study interventions on study outcomes including length of hospitalization and average pain score.
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Monarc versus Miniarc sling
Table 1 Baseline demographics (mean [SD])
Age, years Bodyweight, kg Parity VH/TAH Pad test Leaks/week Total voids/day VAS (/10) IIQ
Monarc (n = 25)
Miniarc (n = 25)
P
46.2 (11.3) 70.8 (14.6) 2.3 (1.4) 36.6% 69.2 (12.1) 7.5 (2.6) 8.1 (8.9) 5.4 (1.6) 17.8 (4.9)
49.6 (11.8) 70.8 (16.4) 2.1 (1.3) 36.5% 74.5 (15.6) 7.8 (2.9) 9.0 (9.1) 6.7 (2.1) 18.6 (5.6)
NS NS NS NS NS NS NS NS NS
IIQ, Incontinence Impact Questionnaire; NS, not significant; SD, standard deviation; TAH, total abdominal hysterectomy; VAS, visual analog scale; VH, vaginal hysterectomy.
Table 2 Surgery (mean [SD])
Time (min) EBL (mL) Hours to discharge VAS pain score (1 h) Fentanyl dose Recovery (weeks)
Monarc (n = 25)
Miniarc (n = 25)
P
22.4 (5.8) 70.0 (38.5) 4.5 (1.1) 1.6 (1.3) 78.3 (13.6) 2.4 (1.3)
18.8 (5.5) 73.0 (30.8) 3.2 (1.3) 1.5 (1.2) 86.0 (15.9) 2.4 (1.4)
0.002 NS NS NS NS NS
NS, not significant; EBL, estimated blood loss; SD, standard deviation; VAS, visual analog scale.
Table 3 Complications
Voiding difficulty
Monarc (n = 25)
Miniarc (n = 25)
P
3 (12%)
0 (0%)
NS (0.07)
Statistical analysis was performed using Student’s t-test and χ2-test with significance reported if P < 0.05. Ethical approval was obtained by the ACT Ethics Committee and the trial registered with Australian New Zealand Clinical Trials Registry (ANZCTR no. 1261 2000 3148 20).
Results There were no significant demographic differences between the two groups (Table 1). In particular, the hysterectomy rate, parity and bodyweights were similar. The only significant intraoperative difference was a shorter operation time for the Miniarc. Unexpectedly the analgesia and hours to discharge were similar in both groups. It was anticipated the three incisions used in the Monarc procedure could create additional pain. Weeks to normal activity times were also similar (Table 2).
There were a greater number of retention episodes in the Monarc group requiring loosening at 7 days (Table 3). These women all then went on to have normal voiding and no incontinence. The success rate at 6 months was reduced in the Miniarc group (84% vs 92%), however, this did not reach significance (Tables 4,5, Fig. 2). Reoperation with a retropubic sling was required in three of the Miniarc group and one in the Monarc group. This did not reach statistical significance.
Discussion This current study found a significant improvement in urinary incontinence in both groups at 6 weeks and 6 months. The success rate at 6 months was reduced in the Miniarc group (84% vs 92%), however, this did not reach statistical significance. The Monarc group had a
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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A. Foote
Table 4 Six-week complications (mean [SD])
Pad test Leaks/week Total voids/day 6-week success 6-week urgency VAS (/10) IIQ
Monarc (n = 25)
Miniarc (n = 25)
P
1.2 (0.6)† 0.4 (0.8)§ 7.4 (1.2) 24 (96%) 1 (4.0%) 1.0 (1.3)†† 8.3 (1.1)§§
2.6 (0.8)‡ 0.7 (0.5)¶ 7.5 (1.8) 23 (92%) 1 (4.0%) 1.5 (1.6)‡‡ 9.5 (1.4)¶¶
NS NS NS NS NS NS NS
†Change from baseline Monarc group pad test, P = 0.0001. ‡Change from baseline Miniarc group pad test, P = 0.0001. §Change from baseline Monarc group leaks/week, P = 0.0001. ¶Change from baseline Miniarc group leaks/week, P = 0.0001. ††Change from baseline Monarc group VAS, P = 0.0001. ‡‡Change from baseline Miniarc group VAS, P = 0.0001. §§Change from baseline Monarc group IIQ, P = 0.0001. ¶¶Change from baseline Miniarc group IIQ, P = 0.0001. IIQ, Incontinence Impact Questionnaire; NS, not significant; SD, standard deviation; VAS, visual analog scale.
Table 5 Six-month complications (mean with [SD])
Leaks/week Total voids/day 6-month success 6-month urgency VAS (/10) IIQ
Monarc (n = 25)
Miniarc (n = 25)
P
0.7 (3.6) 7.0 (1.4) 23 (92.0%) 1 (4%) 0.8 (1.4) 7.4 (1.3)
0.9 (4.0) 7.1 (1.9) 21 (84%) 1 (4%) 0.8 (1.8) 7.5 (1.4)
NS NS NS* NS NS NS
*P = 0.38. IIQ, Incontinence Impact Questionnaire; NS, not significant; SD, standard deviation; VAS, visual analog scale.
9 8 7 6 5 4 3 2 1 0 Leaks/wk 0
Leaks/wk 6w
Leaks/wk 6m
Figure 2 Leakage episodes per week at baseline, six weeks, and six months. Blue line, Monarc; red line, Miniarc.
higher incidence of voiding difficulty requiring sling loosening. Surprisingly, there were no significant differences in the postoperative pain scores and time to discharge, with the single incision of the Miniarc group not appearing to confer extra benefit.
130
This study confirms a paper by Enzelsberger et al.5 who randomized 90 stress-incontinent women for either the Miniarc or the Monarc sling. After 2 years, the continence success rates for the two groups were 82% (Miniarc) and 86% (Monarc). A number of studies have reported similar Miniarc success rates to those found in this current study. De Ridder et al.6 retrospectively compared 75 Miniarc and 56 Monarc procedures over 12 months and found comparable success rates of 85% versus 89%. Kennelly et al.7 has reported the largest follow-up to date of 188 women who had Miniarc surgery, and reported 2-year negative cough test rates of 84.5%. The same group also reported similar success rates for obese and non-obese patients.8 Pickens et al.9 assessed 120 Miniarc sling procedures over 12 months and found a success of 94%. The technique was described of tensioning the sling with a filled bladder until no leakage was demonstrated. One study has reported a poor success rate with the Miniarc sling in a series of 77 patients at 1-year followup, with only 44% being dry.10 This study was performed by one surgeon early after the introduction of
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Monarc versus Miniarc sling
the Miniarc. The surgical technique and failure of mild urethral tensioning might have been factors in the reduced success. Miniarc has also been compared to tension-free vaginal tape (TVT). Basu and Duckett11 randomized 70 women to either Miniarc or retropubic TVT, with follow-up at 6 months. The Miniarc procedure was reported to have a significantly higher recurrence of stress incontinence (odds ratio, 8.14). There was a similar rate of complications in the two groups. The technique for tensioning the Miniarc sling was not described. Other studies have studied mini-slings, although not directly Miniarc versus Monarc slings. The TVT Secur has been the most reported mini-sling, however, it also appears to have had a significantly lower success rate. A meta-analysis of single-incision mini-slings (SIMS) was performed in 2011.12 Included were a total of 758 women in nine randomized controlled trials. Six studies assessed the TVT-Secur, whilst only two studies were of the Miniarc sling, with a total of 78 patients. The standard mid-urethral sling used at randomization was transobturator (TO)-TVT, in seven studies, and retropubic (RT)-TVT in two studies. No studies used Monarc for comparison. Overall, the meta-analysis concluded that SIMS required significantly more repeat continence surgery (risk ratio, 6.72), whilst having shorter operative time, and lower pain scores on day 1. This current study did not find reduced analgesic requirements in the Miniarc group. Hinoul et al.13 in 2011 compared 194 women having TVT Secur and TVT-O in a prospective randomized trial. At 1 year, the success rates were lower in the TVT Secur group (76% vs 92%). In a randomized controlled trial of 90 women with stress incontinence reported by Oliveira et al.,14 the Miniarc yielded 12-month cure rates (87%) similar to that of TVT-O (83%) and superior to that of TVT Secur (67%) in women treated for stress urinary incontinence. This current series can be criticized as the follow-up was performed by the operating surgeon. Longer term follow-up is also required. In conclusion, there were no significant differences between the Miniarc and Monarc, except for a significantly shorter Miniarc sling operating time.
Disclosure There are no conflicts of interest.
References 1. Ulmsten U, Petros P. Intravaginal slingplasty (IVS). An ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol 1995; 29: 75–82. 2. Delorme E. Transobturator urethral suspension. Miniinvasive procedure in the treatment of stress urinary incontinence. Prog Urol 2001; 11: 1306–1313. 3. Martan A, Masata J, Svabík K. SECUR System. Tension-free support of the urethra in women suffering from stress urinary incontinence. Technique and initial experience. Ceska Gynekol 2007; 72: 42–49. 4. Erikson TB. Are there health care utilisation benefits to a less invasive sling. Obstet Gynecol 2008; S4: 111. 5. Enzelsberger H, Cemer I, Enzelsberger S, Schalupny J. MiniArc versus Monarc – a prospective randomized study of the treatment of female stress urinary incontinence with a follow-up of 2 years. Geburtshilfe Frauenheilkd 2010; 70: 499– 502. 6. De Ridder D, Berkers J, Deprest J et al. Single incision minisling versus a transobutaror sling: A comparative study on MiniArcTM and MonarcTM slings. Int Urogynecol J 2010; 21: 773–777. 7. Kennelly MJ, Moore R, Nguyen JN et al. Miniarc singleincision sling for treatment of stress urinary incontinence: 2-year clinical outcomes. Int Urogynecol J 2012; 23: 1285–1291. 8. Moore RD, De Ridder D, Kennelly MJ. Two-year evaluation of the MiniArc in obese versus non-obese patients for treatment of stress urinary incontinence. Int J Urol 2013; 20: 434–440. 9. Pickens RB, Klein FA, Mobley JD, White WM. Single incision mid-urethral sling for treatment of female stress urinary incontinence. Urology 2011; 77: 321–325. 10. Hogewoning CRC, Ruhe IMC, Bekker MD et al. The MiniArc sling for female stress urinary incontinence: Clinical results after 1-year follow-up. Int Urogynecol J 2011; 23: 589–595. 11. Basu M, Duckett J. A randomised trial of a retropubic tensionfree vaginal tape versus a mini-sling for stress incontinence. BJOG 2011; 117: 730–735. 12. Abdel-Fattah M, Ford JA, Lim CP, Madhuvrata P. Singleincision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: A meta-analysis of effectiveness and complications. Eur Urol 2011; 60: 468–480. 13. Hinoul P, Vervest HA, den Boon J et al. A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence. J Urol 2011; 185: 1356–1362. 14. Oliveira R, Botelho F, Silva P et al. Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and MiniArc: Results at 12-month follow-up. Eur Urol 2011; 59: 940–944.
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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doi:10.1111/jog.12493
J. Obstet. Gynaecol. Res. Vol. 41, No. 1: 127–131, January 2015
Randomized prospective study comparing Monarc and Miniarc suburethral slings Andrew Foote1,2 1
Calvary Hospital, and 2Australian National University, Canberra, Australian Capital Territory, Australia
Abstract Aim: Recently a miniature version of the Monarc suburethral sling has been introduced. This paper aims to evaluate the postoperative recovery, effectiveness and complications of these two types of suburethral sling. Methods: This was a prospective randomized series of 50 female patients with stress incontinence who underwent either a Monarc or Miniarc suburethral sling. Results: The only significant intraoperative difference was a shorter operation time for the Miniarc (18.8 vs 22.4 min). The success rates were similar at 6 weeks and 6 months. Conclusion: There were no significant differences between the Miniarc and Monarc, except for a significantly shorter Miniarc sling operating time. Key words: female urinary incontinence, prospective randomized trial, suburethral sling.
Introduction Female stress urinary incontinence is defined as the involuntary loss of urine on effort or physical exertion. Prior to the 1990s, surgical treatment was a major procedure, performed via a significant lower abdominal skin incision and the placement of bladder elevating sutures or a fascial sling under the urethra. The minimally invasive synthetic retropubic suburethral sling was first described in 1995.1 A transobturator approach was introduced in 2001.2 A miniature sling was introduced in 2007,3 thence the Miniarc sling in 2008. An initial trial of 33 cases4 has reported a success rate of 95% at 6 weeks, with a decrease in postoperative discomfort and voiding dysfunction. This paper primarily aims to evaluate the postoperative short-term recovery after sling surgery, and in particular the pain scores and time to recover. It was hypothesized that the single Miniarc incision would cause less pain than the three incisions used in the Monarc procedure. Secondary outcome studies were
the effectiveness and complications of these two types of suburethral sling.
Methods This was a randomized prospective trial of 50 women with stress urinary incontinence. All patients were evaluated with history, examination, bladder diary, Incontinence Impact Questionnaire (IIQ), visual analog scale (VAS) of subjective urinary incontinence bother and urodynamics. Twin-channel urodynamics were performed evaluating filling, presence of any incontinence and voiding. Ultrasound assessment was performed of the bladder neck. A 1-h pad test was also performed with a standard set of exercises conducted after drinking 500 mL of water. Included in this study were women with urodynamically proven genuine stress incontinence, no previous retropubic incontinence surgery, no allergy to polypropylene, no significant voiding difficulty, fit for surgery, no other vaginal surgical procedures being performed concurrently and able to
Received: February 20 2014. Accepted: May 7 2014. Reprint request to: Dr Andrew Foote, 9/3 Sydney Avenue, Barton, Canberra, ACT 2600, Australia. Email: [email protected]
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
127
A. Foote
Flow Diagram Enrollment
Assessed for eligibility (n=61) Excluded (n= 11) ♦ Not meeting inclusion criteria (n= 9) ♦ Declined to participate (n= 2) Randomized (n= 50)
Allocation Allocated to Monarc intervention (n= 25) ♦ Received allocated intervention (n= 25)
Allocated to Miniarc intervention (n= 25) ♦ Received allocated intervention (n= 25) Follow-Up 6months
Lost to follow-up (n= 0)
Lost to follow-up (n= 0)
Analysis Analysed (n= 50) ♦ Excluded from analysis (n= 0)
Analysed (n= 50) ♦ Excluded from analysis (n= 0)
Figure 1 Study flow.
complete the study questionnaires. Sixty-one patients were invited to participate, however, 11 did not enroll in the trial (Fig. 1). All surgeries were performed by the author, or under his direct supervision of registrars. Both procedures were performed under general anesthesia. The obturator Monarc sling was inserted via two 5-mm labia majora incisions and one 10-mm anterior suburethral vaginal incision using the Monarc introducers. The Miniarc prolene sling was inserted via a single anterior vaginal incision (1 cm) and the prolene anchors attached to the left and right obturator fascia. For both procedures, tension was corrected so that no leakage was demonstrated with suprapubic pressure with the bladder filled to 300 mL. Check cystoscopy was performed, and the patient discharged upon voiding with a residual of less than 100 mL on bladder scan and a pain score of less than 5.
128
Short-term outcome measures assessed were operative time, estimated blood loss, hours in hospital, 4-h VAS pain score with no postoperative parenteral analgesia. Fentanyl 100 mg was able to be given intraoperatively if required.
Follow-up Follow-up was at 6 weeks and 6 months to determine objective surgical success by pad testing and questionnaires. Success was defined as a 1-h pad test weighing 1 g or less. Other evaluation at these visits was by examination with a full bladder, history of any urinary symptoms (incontinence, urgency, voiding difficulty), VAS, IIQ short questionnaire and bladder diary. Statistical power calculation estimated that 50 patients would provide a more than 90% power to detect a 20% difference in the effect of study interventions on study outcomes including length of hospitalization and average pain score.
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Monarc versus Miniarc sling
Table 1 Baseline demographics (mean [SD])
Age, years Bodyweight, kg Parity VH/TAH Pad test Leaks/week Total voids/day VAS (/10) IIQ
Monarc (n = 25)
Miniarc (n = 25)
P
46.2 (11.3) 70.8 (14.6) 2.3 (1.4) 36.6% 69.2 (12.1) 7.5 (2.6) 8.1 (8.9) 5.4 (1.6) 17.8 (4.9)
49.6 (11.8) 70.8 (16.4) 2.1 (1.3) 36.5% 74.5 (15.6) 7.8 (2.9) 9.0 (9.1) 6.7 (2.1) 18.6 (5.6)
NS NS NS NS NS NS NS NS NS
IIQ, Incontinence Impact Questionnaire; NS, not significant; SD, standard deviation; TAH, total abdominal hysterectomy; VAS, visual analog scale; VH, vaginal hysterectomy.
Table 2 Surgery (mean [SD])
Time (min) EBL (mL) Hours to discharge VAS pain score (1 h) Fentanyl dose Recovery (weeks)
Monarc (n = 25)
Miniarc (n = 25)
P
22.4 (5.8) 70.0 (38.5) 4.5 (1.1) 1.6 (1.3) 78.3 (13.6) 2.4 (1.3)
18.8 (5.5) 73.0 (30.8) 3.2 (1.3) 1.5 (1.2) 86.0 (15.9) 2.4 (1.4)
0.002 NS NS NS NS NS
NS, not significant; EBL, estimated blood loss; SD, standard deviation; VAS, visual analog scale.
Table 3 Complications
Voiding difficulty
Monarc (n = 25)
Miniarc (n = 25)
P
3 (12%)
0 (0%)
NS (0.07)
Statistical analysis was performed using Student’s t-test and χ2-test with significance reported if P < 0.05. Ethical approval was obtained by the ACT Ethics Committee and the trial registered with Australian New Zealand Clinical Trials Registry (ANZCTR no. 1261 2000 3148 20).
Results There were no significant demographic differences between the two groups (Table 1). In particular, the hysterectomy rate, parity and bodyweights were similar. The only significant intraoperative difference was a shorter operation time for the Miniarc. Unexpectedly the analgesia and hours to discharge were similar in both groups. It was anticipated the three incisions used in the Monarc procedure could create additional pain. Weeks to normal activity times were also similar (Table 2).
There were a greater number of retention episodes in the Monarc group requiring loosening at 7 days (Table 3). These women all then went on to have normal voiding and no incontinence. The success rate at 6 months was reduced in the Miniarc group (84% vs 92%), however, this did not reach significance (Tables 4,5, Fig. 2). Reoperation with a retropubic sling was required in three of the Miniarc group and one in the Monarc group. This did not reach statistical significance.
Discussion This current study found a significant improvement in urinary incontinence in both groups at 6 weeks and 6 months. The success rate at 6 months was reduced in the Miniarc group (84% vs 92%), however, this did not reach statistical significance. The Monarc group had a
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
129
A. Foote
Table 4 Six-week complications (mean [SD])
Pad test Leaks/week Total voids/day 6-week success 6-week urgency VAS (/10) IIQ
Monarc (n = 25)
Miniarc (n = 25)
P
1.2 (0.6)† 0.4 (0.8)§ 7.4 (1.2) 24 (96%) 1 (4.0%) 1.0 (1.3)†† 8.3 (1.1)§§
2.6 (0.8)‡ 0.7 (0.5)¶ 7.5 (1.8) 23 (92%) 1 (4.0%) 1.5 (1.6)‡‡ 9.5 (1.4)¶¶
NS NS NS NS NS NS NS
†Change from baseline Monarc group pad test, P = 0.0001. ‡Change from baseline Miniarc group pad test, P = 0.0001. §Change from baseline Monarc group leaks/week, P = 0.0001. ¶Change from baseline Miniarc group leaks/week, P = 0.0001. ††Change from baseline Monarc group VAS, P = 0.0001. ‡‡Change from baseline Miniarc group VAS, P = 0.0001. §§Change from baseline Monarc group IIQ, P = 0.0001. ¶¶Change from baseline Miniarc group IIQ, P = 0.0001. IIQ, Incontinence Impact Questionnaire; NS, not significant; SD, standard deviation; VAS, visual analog scale.
Table 5 Six-month complications (mean with [SD])
Leaks/week Total voids/day 6-month success 6-month urgency VAS (/10) IIQ
Monarc (n = 25)
Miniarc (n = 25)
P
0.7 (3.6) 7.0 (1.4) 23 (92.0%) 1 (4%) 0.8 (1.4) 7.4 (1.3)
0.9 (4.0) 7.1 (1.9) 21 (84%) 1 (4%) 0.8 (1.8) 7.5 (1.4)
NS NS NS* NS NS NS
*P = 0.38. IIQ, Incontinence Impact Questionnaire; NS, not significant; SD, standard deviation; VAS, visual analog scale.
9 8 7 6 5 4 3 2 1 0 Leaks/wk 0
Leaks/wk 6w
Leaks/wk 6m
Figure 2 Leakage episodes per week at baseline, six weeks, and six months. Blue line, Monarc; red line, Miniarc.
higher incidence of voiding difficulty requiring sling loosening. Surprisingly, there were no significant differences in the postoperative pain scores and time to discharge, with the single incision of the Miniarc group not appearing to confer extra benefit.
130
This study confirms a paper by Enzelsberger et al.5 who randomized 90 stress-incontinent women for either the Miniarc or the Monarc sling. After 2 years, the continence success rates for the two groups were 82% (Miniarc) and 86% (Monarc). A number of studies have reported similar Miniarc success rates to those found in this current study. De Ridder et al.6 retrospectively compared 75 Miniarc and 56 Monarc procedures over 12 months and found comparable success rates of 85% versus 89%. Kennelly et al.7 has reported the largest follow-up to date of 188 women who had Miniarc surgery, and reported 2-year negative cough test rates of 84.5%. The same group also reported similar success rates for obese and non-obese patients.8 Pickens et al.9 assessed 120 Miniarc sling procedures over 12 months and found a success of 94%. The technique was described of tensioning the sling with a filled bladder until no leakage was demonstrated. One study has reported a poor success rate with the Miniarc sling in a series of 77 patients at 1-year followup, with only 44% being dry.10 This study was performed by one surgeon early after the introduction of
© 2014 The Author Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
Monarc versus Miniarc sling
the Miniarc. The surgical technique and failure of mild urethral tensioning might have been factors in the reduced success. Miniarc has also been compared to tension-free vaginal tape (TVT). Basu and Duckett11 randomized 70 women to either Miniarc or retropubic TVT, with follow-up at 6 months. The Miniarc procedure was reported to have a significantly higher recurrence of stress incontinence (odds ratio, 8.14). There was a similar rate of complications in the two groups. The technique for tensioning the Miniarc sling was not described. Other studies have studied mini-slings, although not directly Miniarc versus Monarc slings. The TVT Secur has been the most reported mini-sling, however, it also appears to have had a significantly lower success rate. A meta-analysis of single-incision mini-slings (SIMS) was performed in 2011.12 Included were a total of 758 women in nine randomized controlled trials. Six studies assessed the TVT-Secur, whilst only two studies were of the Miniarc sling, with a total of 78 patients. The standard mid-urethral sling used at randomization was transobturator (TO)-TVT, in seven studies, and retropubic (RT)-TVT in two studies. No studies used Monarc for comparison. Overall, the meta-analysis concluded that SIMS required significantly more repeat continence surgery (risk ratio, 6.72), whilst having shorter operative time, and lower pain scores on day 1. This current study did not find reduced analgesic requirements in the Miniarc group. Hinoul et al.13 in 2011 compared 194 women having TVT Secur and TVT-O in a prospective randomized trial. At 1 year, the success rates were lower in the TVT Secur group (76% vs 92%). In a randomized controlled trial of 90 women with stress incontinence reported by Oliveira et al.,14 the Miniarc yielded 12-month cure rates (87%) similar to that of TVT-O (83%) and superior to that of TVT Secur (67%) in women treated for stress urinary incontinence. This current series can be criticized as the follow-up was performed by the operating surgeon. Longer term follow-up is also required. In conclusion, there were no significant differences between the Miniarc and Monarc, except for a significantly shorter Miniarc sling operating time.
Disclosure There are no conflicts of interest.
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