Research
ajog.org
GYNECOLOGY
Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results Joseph K.-S. Lee, FRANZCOG, MD; Anna Rosamilia, FRCOG, FRANZCOG, PhD, MD; Peter L. Dwyer, FRCOG, FRANZCOG, MD; Yik N. Lim, FRANZCOG, MD; Reinhold Muller, PhD OBJECTIVE: The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months. STUDY DESIGN: A total of 225 women were randomized to receive
MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical
data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate. RESULTS: There was no statistically significant difference in the
subjective (92.2% vs 94.2%; P ¼ .78; difference, 2.0%; 95% confidence interval, e2.7% to þ6.7%) or objective (94.4% vs 96.7%; P ¼ .50; difference, 2.3%; 95% confidence interval, e1.5% to þ6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms. CONCLUSION: MiniArc outcomes are not inferior to Monarc MUS
outcomes at 12 months’ follow-up in women without intrinsic sphincter deficiency. Key words: midurethral slings, MiniArc, Monarc, patient-reported outcomes, randomized controlled trial, stress urinary incontinence
Cite this article as: Lee JK-S, Rosamilia A, Dwyer PL, et al. Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 months results. Am J Obstet Gynecol 2015;213:35.e1-9.
F
emale stress urinary incontinence (SUI) is a prevalent, costly, and burdensome condition for women. Surgery for female SUI has increased, with midurethral slings procedures (MUS) becoming increasingly popular.1,2 Systematic reviews
have shown MUS to be just as effective as traditional continence operations such as pubovaginal slings or Burch colposuspension.3-5 Although the first modern MUS was described more than 15 years ago using
a retropubic approach, the transobturator approach was introduced 5 years later in an attempt to reduce potential complications by avoiding the Cave of Retzius. When compared with the transobturator approach, an
From the Department of Urogynecology, Mercy Hospital for Women, Heidelberg (Drs Lee, Dwyer, and Lim); Pelvic Floor Clinic, Monash Medical Center, Moorabbin (Drs Rosamilia and Lee), Faculty of Medicine, University of Melbourne (Drs Lee and Dwyer), and Faculty of Medicine, Monash University (Dr Rosamillia), Melbourne, VIC, and, School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD (Dr Muller), Australia. Received July 2, 2014; revised Jan. 14, 2015; accepted Jan. 26, 2015. This investigator-led randomized controlled trial received an external research grant from American Medical Systems, Minnetonka, MN (J.K.-S.L., A.R., P.L.D., and Y.N.L.). The other author reports no conflict of interest. Protocol development was independent of American Medical Systems. American Medical Systems did not have access nor did they ask for access to our data, to which we hold exclusive rights. Data analysis was done exclusively by the authors. No editorial request was made from American Medical Systems regarding this manuscript submission. The 6-month and 12-month results of this study were presented at the 37th and 38th annual meetings of the International Urogynecological Association, Brisbane, QLD, Australia, Sept. 4-8, 2012, and Dublin, Ireland, May 28 through June 1, 2013, respectively. Corresponding author: Joseph Lee, FRANZCOG, MD. [email protected] 0002-9378/$36.00 ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2015.01.040
JULY 2015 American Journal of Obstetrics & Gynecology
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Gynecology
increased rate of bladder perforations and pelvic hematomas were observed among those who had retropubic MUS,3,4 despite a largely equivalent cure rate in the medium term. However, both retropubic and transobturator MUS continue to have clinically significant complications such as bladder injuries, mesh exposures, voiding difficulties, de novo urgency, and groin/thigh pain.4,6 Single-incision slings, such as the MiniArc (American Medical Systems, Minnetonka, MN), are designed with self-anchoring mechanisms to the pelvic sidewalls and require no trocar passage through the obturator foramen or external skin incisions, which could reduce postoperative pain and shorten postoperative recovery. Early case series7,8 of 12-month follow-up showed limited length of stay, a low complication rate, and minimal postoperative pain with a high cure rate, suggestive of a potential clinical advantage. A retrospective cohort comparative study of MiniArc and Monarc (American Medical Systems) showed a comparable objective cure, incontinence impact, and satisfaction at 12-month follow-up.9 Our aim was to examine the cure rates and perioperative outcomes of Monarc and MiniArc at 6 and 12 months in a randomized controlled trial (RCT).
M ATERIALS
AND
M ETHODS
In this pragmatic RCT, women who had SUI or urodynamic stress incontinence who failed conservative treatments and requested surgery were recruited between May 30, 2009, and Dec. 14, 2011, from tertiary urogynecology clinics. All recruited women reported SUI. Women with intrinsic sphincter deficiency (ISD), previous MUS, untreated detrusor overactivity, or significant voiding dysfunction (maximum flow rate .99
5 (3e8)
5 (3e8)
.72
PISQ12
33 (28e37)
33 (29e38)
.91
Not sexually active, %
21 (18.8)
23 (20.7)
.74
> .99
Baseline functional outcomes
ICIQ OAB
a
a
IIQ7a a
PGI-S
24 hour pad, g, mean SDc
.37
9 (5e13)
9 (5e12)
.65
3 (2e3)
3 (3e3)
.04b
21.1 33.9
28.5 43.1
.22
Urodynamic findings USI, %
99 (90.0)
100 (90.9)
DO, %
11 (10.0)
5 (4.5)
MUCP, mean SD
.19
40.9 17
.79
107 29.0
109.8 51.5
.65
Ba, mean SD
1.47 1.10
1.29 1.20
.24
Bp, mean SD
1.28 1.19
1.18 1.45
.57
C, mean SD
6.05 1.82
5.92 2.56
.62
ALPP, mean SD
40.3 15.5
> .99
POPq
Prolapse surgery Concomitant POP, %
44 (39.3)
54 (47.8)
.23
VH A/P or AP, %
23 (20.5)
35 (31.0)
.09
Anterior mesh or ASC, %
5 (4.5)
4 (3.5)
.75
Posterior only mesh, %
16 (14.3)
15 (13.3)
.85
ALPP, abdominal leak point pressure; AP, anterior and posterior vaginal repair; ASC, abdominal sacrocolpopexy; BMI, body mass index; chest Neuro DM CT, chronic chest condition (eg, asthma chronic obstructive airways disease, significant neurological condition [eg, multiple sclerosis, diabetes, connective tissue disease]); DO, detrusor overactivity; ICIQ, International Consultation on Icontinence Questionnaire; ICIQ OAB, ICIQ Overactive Bladder; IIQ, Incontinence Impact Questionnaire; MiniMo, MiniArc Monarc; MUCP, maximum urethral closure pressure; PGII, Patient Global Impression of Improvement; PISQ12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; POP, pelvic organ prolapse; POPq, pelvic organ prolapse quantification; RCT, randomized controlled trial; SUI, stress urinary incontinence; UI SF, Urinary Incontinence Short Form; USI, urodynamic stress incontinence; VH, vaginal hysterectomy. a
Median (interquartile range, 25e75%); b Value less than .05; c Proportion of completed pad tests were 66.1% for Miniarc and 98.2% for Monarc (American Medical Systems, Minnetonka, MN).
Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
35.e4 American Journal of Obstetrics & Gynecology JULY 2015
The mean age of all patients was 51.6 9.71 years (range, 31e80 years), body mass index (BMI) of 27.5 5.6 kg/m2 (range, 15.2e46.9 kg/m2), and a median parity of 2 (quartiles 2e3; range, 0e7). Figure 1 depicted the CONSORT flowchart, accounting for all participants, including those lost to follow-up and those who were eligible but declined to participate. Table 1 displayed baseline characteristics of women who received allocation to either sling. It showed no statistically significant difference between the 2 treatment arms for known confounders, which included age, parity, BMI, prior medical history, baseline symptom severity (excluding Patient Global Impression of Severity), urodynamic diagnosis, vaginal topography, and types of concomitant prolapse surgeries. Table 2 detailed intraoperative and postoperative data to 6 weeks. For women who underwent sling only (without concomitant prolapse surgery), the Monarc procedure was longer by half a minute (8.5 vs 8.0 minutes, P ¼ .002) with women requiring more analgesia (2 vs 0.5 tablets, P ¼ .002) in the first 24 hours and more women reporting shortterm groin pain (34 vs 10, P < .001), although the observed larger (medians of 4 vs 1) number of women requiring catheter longer than 24 hours did not reach statistical significance. For those who underwent the concomitant prolapse procedure, more women who had Monarc required a catheter for 1e2 days (19 vs 2, P ¼ .0003) compared with those who had MiniArc. Table 3 detailed subjective and objective cure rates at 6 and 12 months. Subjective cure rates were very similar between the MiniArc and Monarc patients at 6 months (95.5% vs 92.5%, P ¼ .4) and at 12 months (92.2% vs 94.2%, P ¼ .78), respectively. This mirrored the similar objective cure rates between MiniArc and Monarc at 6 months (81.1% vs 86.3%, P ¼ .43) and at 12 months (94.4% vs 96.7%, P ¼ .50), respectively. Objective cure was determined on the basis of an absence of urodynamic stress
Gynecology
ajog.org incontinence at 6 months, whereas it was determined by a negative clinical cough stress test at 12 months, which explains the change in objective cure rate. Similar subjective and objective cure was seen for those who had either MiniArc or Monarc only (ie, no concomitant prolapse surgery) at 6 and 12 months. Assuming all missing data were failures, similar subjective and objective cure rates were observed between the 2 treatment arms at 6 or 12 months, including those who had sling only. Specifically, at 6 months, the subjective/ objective cure rates for MiniArc and Monarc were 93.8% and 87.6% and 68.8% and 72.5%, respectively. At 12 months, assuming all lost to follow-up were failures, the subjective/objective cure rates for MiniArc and Monarc were 84.8% and 85.8% and 75% and 77%, respectively. In Table 4, functional outcomes (patient reported symptom distress, incontinence impact, and sexual outcomes) between the 2 treatment arms at 6 and 12 months are tabulated, and Figure 2 depicted the box-whisker plots (median/ interquartile scores) of PROs (ICIQ UI SF, ICIQ OAB, IIQ7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12, and PGII) from both slings at baseline, 6 months, and 12 months. There was no statistically significant difference in the ICIQ UI or ICIQ OAB score between both arms at 6 or 12 months, although the proportion using antimuscarinics was lower for women who had the MiniArc sling at 12 months compared with those who had Monarc (5.7% vs 15.8%, P ¼ .034). Although the 24 hour pad weigh was heavier in women who had MiniArc, compared with Monarc (4 g vs 2 g, P ¼ .89), it did not reach statistical significance. There was no significant difference in the PISQ-12 score or the proportion of those not sexually active between both arms at both time points, reflecting no change in sexual function postoperatively. Similarly, there was no difference in the IIQ-7 and PGII scores between both arms at both time points, reflecting low incontinence impact and high satisfaction for women in both arms.
Research
TABLE 2
Operative characteristics Sling only Time, min
a
Catheter longer than 1 d Panadeine use
a
Groin pain
MiniArc (n [ 68)
Monarc (n [ 59)
8.0 (6.0e10.0)
8.5 (8.0e12.0)
.002b
1
4
.170
0.5 (0.0e2.0)
2.0 (0.3e6.0)
.002b
10
34
Duration 1e3 d
2
20
Duration 4e7 d
5
7
Duration 2e4 wks
3
< .001b
7
MiniArc (n ¼ 44)
Concomitant POP
P value
Monarc (n ¼ 54)
Catheter 1e2 d
2
19
Catheter 3e4 d
1
1
Catheter 7 d
1
1
.0003b
MiniArc and Monarc; American Medical Systems, Minnetonka, MN. POP, pelvic organ prolapse. a
Median (interquartile range, 25e75%) panadeine use reflects usage in 24 hours; b Value less than .05.
Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
There was a single case of voiding dysfunction in each arm (both had low maximum flow of 10-11 mL/s, postvoid residual of >100 mL), but none necessitated sling release. Three women within the MiniArc arm required repeat surgery compared with 2 in the Monarc arm
(2.7% vs 1.8%, P ¼.68). There were more women in the Monarc arm (6.2% vs 0%, P ¼ .014) reporting groin pain beyond 6 months than those in the MiniArc arm, although none required pharmacological or surgical intervention. Paraurethral prominence was detected in 3 who had
TABLE 3
Subjective and objective SUI cure rates MiniArc (n [ 112)
Monarc (n [ 113)
P value
Cure rates
6 mo
12 mo
6 mo
12 mo
6 m vs 6 mo
Subjective
105/110
95/103
99/107
97/103
.40
.78
95.5
92.2
92.5
94.2
77/95
84/89
82/95
87/90
.43
.50
81.1
94.4
86.3
96.7
.70
> .99
.80
> .99
% Objective %
Sling only Subjective % Objective %
12 m vs 12 mo
Sling only
63/66
57/62
52/56
49/57
95.5
91.9
92.9
90.7
47/58
47/51
43/51
42/45
81.0
92.2
84.3
93.3
Objective was that urodynamic stress incontinence or cough stress test at 6 months, cough stress test at 12 months. MiniArc and Monarc; American Medical Systems, Minnetonka, MN. SUI, stress urinary incontinence. Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
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ajog.org
TABLE 4
Functional outcomes MiniArc (n [ 112) Outcome ICIQ UI SF
6 mo a
Monarc (n [ 113) 12 mo
4 (0e7)
b
9
ICIQ OABa
3 (2e5)
b
8
4 (0e6) 14
6 mo 3 (0e6) 10
3 (1e4) 10
12 mo 3 (0e6) 3 (2e5)
11
17
14/96 14.6%
15/95 15.8%
10/92 10.9%
b
20
25
17
18
PISQ12a
36 (33e40)
37 (34e41)
39 (33e41)
38 (33e41)
b
34
43
39
40
NSA
25/103
26/95
29/103
22/95
17
10
18
9
IIQ7
a
0 (0e4)
b
10
PGIIa
1 (1e2)
b
10 a
24 hour pad b
0 (0e3) 14
0 (0e3) 10
1 (1e2) 14
1 (1e2) 11
4 (0e8)
12 mo vs 12 mo
.77
.61
.57
.48
.52
.034c
.06
.91
.64
.62
0 (0e3)
.70
.88
.90
.46
20 1 (1e2) 19
2 (2e6)
46
6 mo vs 6 mo
18
OAB Medications
b
5/87 5.7%
3 (2e5)
P value
.89
54
MiniArc and Monarc; American Medical Systems, Minnetonka, MN. ICIQ, International Consultation on Icontinence Questionnaire; ICIQ OAB, ICIQ Overactive Bladder; IIQ, Incontinence Impact Questionnaire; MiniMo, MiniArc Monarc; NSA, not sexually active; PGII, Patient Global Impression of Improvement; PISQ12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; UI SF, Urinary Incontinence Short Form. a
Median (interquartile range, 25e75%); b Total number incomplete data; c Value less than .05.
Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
Monarc sling. There was 1 mesh exposure because of the mesh kit in the Miniarc arm, in a patient who also had an elevate anterior. Multivariate logistic regression analyses (Table 5) were performed for subjective and objective outcome at 12 months, which assessed all preoperative patient data, including operator/surgeon for potential confounding. None of the assessed variables showed any significant confounding of the effects of PGI-S or surgeon type, thus validating the bivariate results shown in Tables 1, 3, and 4. In both arms, age was found as the only variable that showed an independent effect on objective cure rate at 12 months, with failure rates increasing with age (bivariate observations were 0%, 2.6%, 5.4%, and 10% for those up to 45, 46e50, 51e60, and older than 60 years of age, respectively; P < .029, exact binomial trend test). Also in both arms,
BMI was found as the only variable with an independent effect on subjective cure rate at 12 months, with failure rates increasing with BMI (bivariate failure rates were 0%, 2,7%, 3.0%, and 15.9% for BMIs of under 18.5, 18.5 to
ajog.org
GYNECOLOGY
Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results Joseph K.-S. Lee, FRANZCOG, MD; Anna Rosamilia, FRCOG, FRANZCOG, PhD, MD; Peter L. Dwyer, FRCOG, FRANZCOG, MD; Yik N. Lim, FRANZCOG, MD; Reinhold Muller, PhD OBJECTIVE: The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months. STUDY DESIGN: A total of 225 women were randomized to receive
MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical
data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate. RESULTS: There was no statistically significant difference in the
subjective (92.2% vs 94.2%; P ¼ .78; difference, 2.0%; 95% confidence interval, e2.7% to þ6.7%) or objective (94.4% vs 96.7%; P ¼ .50; difference, 2.3%; 95% confidence interval, e1.5% to þ6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms. CONCLUSION: MiniArc outcomes are not inferior to Monarc MUS
outcomes at 12 months’ follow-up in women without intrinsic sphincter deficiency. Key words: midurethral slings, MiniArc, Monarc, patient-reported outcomes, randomized controlled trial, stress urinary incontinence
Cite this article as: Lee JK-S, Rosamilia A, Dwyer PL, et al. Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 months results. Am J Obstet Gynecol 2015;213:35.e1-9.
F
emale stress urinary incontinence (SUI) is a prevalent, costly, and burdensome condition for women. Surgery for female SUI has increased, with midurethral slings procedures (MUS) becoming increasingly popular.1,2 Systematic reviews
have shown MUS to be just as effective as traditional continence operations such as pubovaginal slings or Burch colposuspension.3-5 Although the first modern MUS was described more than 15 years ago using
a retropubic approach, the transobturator approach was introduced 5 years later in an attempt to reduce potential complications by avoiding the Cave of Retzius. When compared with the transobturator approach, an
From the Department of Urogynecology, Mercy Hospital for Women, Heidelberg (Drs Lee, Dwyer, and Lim); Pelvic Floor Clinic, Monash Medical Center, Moorabbin (Drs Rosamilia and Lee), Faculty of Medicine, University of Melbourne (Drs Lee and Dwyer), and Faculty of Medicine, Monash University (Dr Rosamillia), Melbourne, VIC, and, School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD (Dr Muller), Australia. Received July 2, 2014; revised Jan. 14, 2015; accepted Jan. 26, 2015. This investigator-led randomized controlled trial received an external research grant from American Medical Systems, Minnetonka, MN (J.K.-S.L., A.R., P.L.D., and Y.N.L.). The other author reports no conflict of interest. Protocol development was independent of American Medical Systems. American Medical Systems did not have access nor did they ask for access to our data, to which we hold exclusive rights. Data analysis was done exclusively by the authors. No editorial request was made from American Medical Systems regarding this manuscript submission. The 6-month and 12-month results of this study were presented at the 37th and 38th annual meetings of the International Urogynecological Association, Brisbane, QLD, Australia, Sept. 4-8, 2012, and Dublin, Ireland, May 28 through June 1, 2013, respectively. Corresponding author: Joseph Lee, FRANZCOG, MD. [email protected] 0002-9378/$36.00 ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2015.01.040
JULY 2015 American Journal of Obstetrics & Gynecology
35.e1
Research
Gynecology
increased rate of bladder perforations and pelvic hematomas were observed among those who had retropubic MUS,3,4 despite a largely equivalent cure rate in the medium term. However, both retropubic and transobturator MUS continue to have clinically significant complications such as bladder injuries, mesh exposures, voiding difficulties, de novo urgency, and groin/thigh pain.4,6 Single-incision slings, such as the MiniArc (American Medical Systems, Minnetonka, MN), are designed with self-anchoring mechanisms to the pelvic sidewalls and require no trocar passage through the obturator foramen or external skin incisions, which could reduce postoperative pain and shorten postoperative recovery. Early case series7,8 of 12-month follow-up showed limited length of stay, a low complication rate, and minimal postoperative pain with a high cure rate, suggestive of a potential clinical advantage. A retrospective cohort comparative study of MiniArc and Monarc (American Medical Systems) showed a comparable objective cure, incontinence impact, and satisfaction at 12-month follow-up.9 Our aim was to examine the cure rates and perioperative outcomes of Monarc and MiniArc at 6 and 12 months in a randomized controlled trial (RCT).
M ATERIALS
AND
M ETHODS
In this pragmatic RCT, women who had SUI or urodynamic stress incontinence who failed conservative treatments and requested surgery were recruited between May 30, 2009, and Dec. 14, 2011, from tertiary urogynecology clinics. All recruited women reported SUI. Women with intrinsic sphincter deficiency (ISD), previous MUS, untreated detrusor overactivity, or significant voiding dysfunction (maximum flow rate .99
5 (3e8)
5 (3e8)
.72
PISQ12
33 (28e37)
33 (29e38)
.91
Not sexually active, %
21 (18.8)
23 (20.7)
.74
> .99
Baseline functional outcomes
ICIQ OAB
a
a
IIQ7a a
PGI-S
24 hour pad, g, mean SDc
.37
9 (5e13)
9 (5e12)
.65
3 (2e3)
3 (3e3)
.04b
21.1 33.9
28.5 43.1
.22
Urodynamic findings USI, %
99 (90.0)
100 (90.9)
DO, %
11 (10.0)
5 (4.5)
MUCP, mean SD
.19
40.9 17
.79
107 29.0
109.8 51.5
.65
Ba, mean SD
1.47 1.10
1.29 1.20
.24
Bp, mean SD
1.28 1.19
1.18 1.45
.57
C, mean SD
6.05 1.82
5.92 2.56
.62
ALPP, mean SD
40.3 15.5
> .99
POPq
Prolapse surgery Concomitant POP, %
44 (39.3)
54 (47.8)
.23
VH A/P or AP, %
23 (20.5)
35 (31.0)
.09
Anterior mesh or ASC, %
5 (4.5)
4 (3.5)
.75
Posterior only mesh, %
16 (14.3)
15 (13.3)
.85
ALPP, abdominal leak point pressure; AP, anterior and posterior vaginal repair; ASC, abdominal sacrocolpopexy; BMI, body mass index; chest Neuro DM CT, chronic chest condition (eg, asthma chronic obstructive airways disease, significant neurological condition [eg, multiple sclerosis, diabetes, connective tissue disease]); DO, detrusor overactivity; ICIQ, International Consultation on Icontinence Questionnaire; ICIQ OAB, ICIQ Overactive Bladder; IIQ, Incontinence Impact Questionnaire; MiniMo, MiniArc Monarc; MUCP, maximum urethral closure pressure; PGII, Patient Global Impression of Improvement; PISQ12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; POP, pelvic organ prolapse; POPq, pelvic organ prolapse quantification; RCT, randomized controlled trial; SUI, stress urinary incontinence; UI SF, Urinary Incontinence Short Form; USI, urodynamic stress incontinence; VH, vaginal hysterectomy. a
Median (interquartile range, 25e75%); b Value less than .05; c Proportion of completed pad tests were 66.1% for Miniarc and 98.2% for Monarc (American Medical Systems, Minnetonka, MN).
Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
35.e4 American Journal of Obstetrics & Gynecology JULY 2015
The mean age of all patients was 51.6 9.71 years (range, 31e80 years), body mass index (BMI) of 27.5 5.6 kg/m2 (range, 15.2e46.9 kg/m2), and a median parity of 2 (quartiles 2e3; range, 0e7). Figure 1 depicted the CONSORT flowchart, accounting for all participants, including those lost to follow-up and those who were eligible but declined to participate. Table 1 displayed baseline characteristics of women who received allocation to either sling. It showed no statistically significant difference between the 2 treatment arms for known confounders, which included age, parity, BMI, prior medical history, baseline symptom severity (excluding Patient Global Impression of Severity), urodynamic diagnosis, vaginal topography, and types of concomitant prolapse surgeries. Table 2 detailed intraoperative and postoperative data to 6 weeks. For women who underwent sling only (without concomitant prolapse surgery), the Monarc procedure was longer by half a minute (8.5 vs 8.0 minutes, P ¼ .002) with women requiring more analgesia (2 vs 0.5 tablets, P ¼ .002) in the first 24 hours and more women reporting shortterm groin pain (34 vs 10, P < .001), although the observed larger (medians of 4 vs 1) number of women requiring catheter longer than 24 hours did not reach statistical significance. For those who underwent the concomitant prolapse procedure, more women who had Monarc required a catheter for 1e2 days (19 vs 2, P ¼ .0003) compared with those who had MiniArc. Table 3 detailed subjective and objective cure rates at 6 and 12 months. Subjective cure rates were very similar between the MiniArc and Monarc patients at 6 months (95.5% vs 92.5%, P ¼ .4) and at 12 months (92.2% vs 94.2%, P ¼ .78), respectively. This mirrored the similar objective cure rates between MiniArc and Monarc at 6 months (81.1% vs 86.3%, P ¼ .43) and at 12 months (94.4% vs 96.7%, P ¼ .50), respectively. Objective cure was determined on the basis of an absence of urodynamic stress
Gynecology
ajog.org incontinence at 6 months, whereas it was determined by a negative clinical cough stress test at 12 months, which explains the change in objective cure rate. Similar subjective and objective cure was seen for those who had either MiniArc or Monarc only (ie, no concomitant prolapse surgery) at 6 and 12 months. Assuming all missing data were failures, similar subjective and objective cure rates were observed between the 2 treatment arms at 6 or 12 months, including those who had sling only. Specifically, at 6 months, the subjective/ objective cure rates for MiniArc and Monarc were 93.8% and 87.6% and 68.8% and 72.5%, respectively. At 12 months, assuming all lost to follow-up were failures, the subjective/objective cure rates for MiniArc and Monarc were 84.8% and 85.8% and 75% and 77%, respectively. In Table 4, functional outcomes (patient reported symptom distress, incontinence impact, and sexual outcomes) between the 2 treatment arms at 6 and 12 months are tabulated, and Figure 2 depicted the box-whisker plots (median/ interquartile scores) of PROs (ICIQ UI SF, ICIQ OAB, IIQ7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12, and PGII) from both slings at baseline, 6 months, and 12 months. There was no statistically significant difference in the ICIQ UI or ICIQ OAB score between both arms at 6 or 12 months, although the proportion using antimuscarinics was lower for women who had the MiniArc sling at 12 months compared with those who had Monarc (5.7% vs 15.8%, P ¼ .034). Although the 24 hour pad weigh was heavier in women who had MiniArc, compared with Monarc (4 g vs 2 g, P ¼ .89), it did not reach statistical significance. There was no significant difference in the PISQ-12 score or the proportion of those not sexually active between both arms at both time points, reflecting no change in sexual function postoperatively. Similarly, there was no difference in the IIQ-7 and PGII scores between both arms at both time points, reflecting low incontinence impact and high satisfaction for women in both arms.
Research
TABLE 2
Operative characteristics Sling only Time, min
a
Catheter longer than 1 d Panadeine use
a
Groin pain
MiniArc (n [ 68)
Monarc (n [ 59)
8.0 (6.0e10.0)
8.5 (8.0e12.0)
.002b
1
4
.170
0.5 (0.0e2.0)
2.0 (0.3e6.0)
.002b
10
34
Duration 1e3 d
2
20
Duration 4e7 d
5
7
Duration 2e4 wks
3
< .001b
7
MiniArc (n ¼ 44)
Concomitant POP
P value
Monarc (n ¼ 54)
Catheter 1e2 d
2
19
Catheter 3e4 d
1
1
Catheter 7 d
1
1
.0003b
MiniArc and Monarc; American Medical Systems, Minnetonka, MN. POP, pelvic organ prolapse. a
Median (interquartile range, 25e75%) panadeine use reflects usage in 24 hours; b Value less than .05.
Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
There was a single case of voiding dysfunction in each arm (both had low maximum flow of 10-11 mL/s, postvoid residual of >100 mL), but none necessitated sling release. Three women within the MiniArc arm required repeat surgery compared with 2 in the Monarc arm
(2.7% vs 1.8%, P ¼.68). There were more women in the Monarc arm (6.2% vs 0%, P ¼ .014) reporting groin pain beyond 6 months than those in the MiniArc arm, although none required pharmacological or surgical intervention. Paraurethral prominence was detected in 3 who had
TABLE 3
Subjective and objective SUI cure rates MiniArc (n [ 112)
Monarc (n [ 113)
P value
Cure rates
6 mo
12 mo
6 mo
12 mo
6 m vs 6 mo
Subjective
105/110
95/103
99/107
97/103
.40
.78
95.5
92.2
92.5
94.2
77/95
84/89
82/95
87/90
.43
.50
81.1
94.4
86.3
96.7
.70
> .99
.80
> .99
% Objective %
Sling only Subjective % Objective %
12 m vs 12 mo
Sling only
63/66
57/62
52/56
49/57
95.5
91.9
92.9
90.7
47/58
47/51
43/51
42/45
81.0
92.2
84.3
93.3
Objective was that urodynamic stress incontinence or cough stress test at 6 months, cough stress test at 12 months. MiniArc and Monarc; American Medical Systems, Minnetonka, MN. SUI, stress urinary incontinence. Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
JULY 2015 American Journal of Obstetrics & Gynecology
35.e5
Research
Gynecology
ajog.org
TABLE 4
Functional outcomes MiniArc (n [ 112) Outcome ICIQ UI SF
6 mo a
Monarc (n [ 113) 12 mo
4 (0e7)
b
9
ICIQ OABa
3 (2e5)
b
8
4 (0e6) 14
6 mo 3 (0e6) 10
3 (1e4) 10
12 mo 3 (0e6) 3 (2e5)
11
17
14/96 14.6%
15/95 15.8%
10/92 10.9%
b
20
25
17
18
PISQ12a
36 (33e40)
37 (34e41)
39 (33e41)
38 (33e41)
b
34
43
39
40
NSA
25/103
26/95
29/103
22/95
17
10
18
9
IIQ7
a
0 (0e4)
b
10
PGIIa
1 (1e2)
b
10 a
24 hour pad b
0 (0e3) 14
0 (0e3) 10
1 (1e2) 14
1 (1e2) 11
4 (0e8)
12 mo vs 12 mo
.77
.61
.57
.48
.52
.034c
.06
.91
.64
.62
0 (0e3)
.70
.88
.90
.46
20 1 (1e2) 19
2 (2e6)
46
6 mo vs 6 mo
18
OAB Medications
b
5/87 5.7%
3 (2e5)
P value
.89
54
MiniArc and Monarc; American Medical Systems, Minnetonka, MN. ICIQ, International Consultation on Icontinence Questionnaire; ICIQ OAB, ICIQ Overactive Bladder; IIQ, Incontinence Impact Questionnaire; MiniMo, MiniArc Monarc; NSA, not sexually active; PGII, Patient Global Impression of Improvement; PISQ12, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire; UI SF, Urinary Incontinence Short Form. a
Median (interquartile range, 25e75%); b Total number incomplete data; c Value less than .05.
Lee. MiniArc or Monarc in women with stress urinary incontinence. Am J Obstet Gynecol 2015.
Monarc sling. There was 1 mesh exposure because of the mesh kit in the Miniarc arm, in a patient who also had an elevate anterior. Multivariate logistic regression analyses (Table 5) were performed for subjective and objective outcome at 12 months, which assessed all preoperative patient data, including operator/surgeon for potential confounding. None of the assessed variables showed any significant confounding of the effects of PGI-S or surgeon type, thus validating the bivariate results shown in Tables 1, 3, and 4. In both arms, age was found as the only variable that showed an independent effect on objective cure rate at 12 months, with failure rates increasing with age (bivariate observations were 0%, 2.6%, 5.4%, and 10% for those up to 45, 46e50, 51e60, and older than 60 years of age, respectively; P < .029, exact binomial trend test). Also in both arms,
BMI was found as the only variable with an independent effect on subjective cure rate at 12 months, with failure rates increasing with BMI (bivariate failure rates were 0%, 2,7%, 3.0%, and 15.9% for BMIs of under 18.5, 18.5 to
