Taiwanese Journal of Obstetrics & Gynecology 53 (2014) 337e342

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Taiwanese Journal of Obstetrics & Gynecology

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Original Article

Factors that affect early recurrence after prolapse repair

by a nonanchored vaginal mesh procedure
Ching-Pei Tsai a, 1, Man-Jung Hung a, b, *, 1, Pao-Sheng Shen c, Gin-Den Chen b,
Tsung-Hsien Su d, Min-Min Chou a, b
a
Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung, Taiwan
b
Department of Obstetrics and Gynecology, Chung Shan Medical University School of Medicine, Taichung, Taiwan
c
Department of Statistics, Tunghai University, Taichung, Taiwan
d
Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan

a r t i c l e i n f o a b s t r a c t

Article history: Objective: Prosima (Ethicon, Somerville, NJ, USA) is a novel procedure for treating pelvic organ prolapse
Accepted 17 October 2012 (POP) that uses nonanchored vaginal mesh. However, nonfixation of the mesh may limit effectiveness.
The aim of this study was to evaluate the safety, efficacy, and limitations of this procedure.
Keywords: Materials and methods: From January 2011 through to December 2011, 52 patients with symptomatic
Data and Safety Monitoring Plan POP
Stage 2 undergoing the Prosima procedure at a tertiary hospital were enrolled consecutively in
midurethral sling
this prospective study. A Data and Safety Monitoring Plan (DSMP) was developed to assess the results.
nonanchored vaginal mesh
Results: Fifty of the 52 patients (96%) attended the 3e6-month postoperative assessment. Symptom and
pelvic organ prolapse
uterine conservation
quality-of-life scores were found to have improved significantly after surgery (p < 0.05). Forty-two pa-
vaginal support device tients (84%) underwent successful treatment for POP (Stage 0-1). The other eight patients (16%) were
found to have recurrent Stage 2 anterior vaginal wall prolapse, although most of them (5/8) were
asymptomatic. The highest morbidity, namely vaginal mesh exposure, occurred in four patients (8%) and
was managed as a minor issue. Statistical analysis showed that anatomic recurrence was significantly
(p < 0.05) associated with a “preoperative Ba
þ4 cm” (odds ratio ¼ 20.57), “conservation of the
prolapsed uterus” (odds ratio ¼ 10.56) and “use of a concomitant midurethral sling” (odds ratio ¼ 0.076).
Conclusion: Prosima seems to have limitations when used to manage severe anterior vaginal wall pro-
lapse and concomitant surgery may further affect its effectiveness. The information obtained from this
study's DSMP will contribute to developing a strategy to improve the use of nonanchored vaginal mesh
for POP repair.
Copyright © 2014, Taiwan Association of Obstetrics & Gynecology. Published by Elsevier Taiwan LLC. All
rights reserved.

Introduction undergo POP repair are aged < 60 years [3]. Therefore, an ideal
surgical intervention for POP should be one that is safe, efficacious,
Based on the most recent survey, the lifetime risk of undergoing and durable.
surgery for pelvic organ prolapse (POP) is 19% among the general Recently, in an attempt to improve surgical outcomes, synthetic
female population, which is higher than the previously reported mesh has been increasingly used during POP reconstructive pelvic
rate of 11e12% [1]. However, attempts to correct this problem still surgery. An updated Cochrane review showed that a native tissue
result in a high failure rate and a significant number of patients anterior vaginal repair is associated with more failures than when
require a second surgical procedure [2]. Most patients (60%) who polypropylene mesh is used as an overlay (relative risk ¼ 2.14) or
when armed transobturator mesh is used (relative risk ¼ 3.55) [4].
In recent years, various trocar-guided vaginal mesh kits have been
* Corresponding author. Department of Obstetrics and Gynecology, Taichung widely used for POP repair. High anatomic success rates and
Veterans General Hospital, Number 160, Section 3, Taichung Harbor Road, Taichung
satisfactory functional outcomes have been reported over a number
40705, Taiwan.
E-mail address: [email protected] (M.-J. Hung). of large case series [5e7], various randomized controlled trials
1
These two authors contributed equally to this work. [8,9], and various prospective comparison studies using a variety of

http://dx.doi.org/10.1016/j.tjog.2014.07.004
1028-4559/Copyright © 2014, Taiwan Association of Obstetrics & Gynecology. Published by Elsevier Taiwan LLC. All rights reserved.
338 C.-P. Tsai et al. / Taiwanese Journal of Obstetrics & Gynecology 53 (2014) 337e342

different mesh kits [10]. Furthermore, it seems that anatomic Quantitation (POPQ) system [15]. The multichannel urodynamic
correction is sustained during both short-term [5,8e10] and study was performed according to methods, definitions, and units
medium-term [6,7] follow-up. that conform to the standards proposed by the International Uro-
Recently, a trocar-free POP repair system using nonanchored gynecological Association and the International Continence Society
mesh and a vaginal support device (VSD; Prosima, Ethicon, Som- [16]. The leak point pressure and the urethral pressure profile were
erville, NJ, USA) has been developed and is thought to provide true both determined with the prolapse protruding and with the pro-
tension-free support with less vaginal distortion and reduced band lapse reduced using a vaginal pessary. Patients were identified as
formation [11,12]; however, nonfixation of the mesh may result in a having “occult” type urodynamic stress incontinence (USI) if stress-
suboptimal suspension effect with this procedure. According to induced urine loss was demonstrated in the absence of a detrusor
recent results reported in the literature, the objective success rates contraction with the prolapse reduced but not with the prolapse
for POP repair (Stage 0e1) using the Prosima procedure are only protruding [16]. Follow-up examinations were performed post-
76.9% and 69.1% at 1- and 2-year follow-up, respectively. These operatively at 6 weeks, 3 months, 6 months, and then annually in
rates are obviously inferior to those achieved by trocar-guided order to assess the anatomic and functional outcomes of the treat-
vaginal mesh kits (from >80% to >90%) over the same or even ment. A follow-up urodynamic study was not routinely performed
longer follow-up periods [5e10]. but was done if urinary symptoms or a positive cough stress test
In order to further understand the safety, efficacy, and possible were indicated the need. The efficacy of the surgery was considered
limitations of the nonanchored vaginal mesh procedure (Prosima), to be “successful” when patients were free of pressure or bulge
we developed a Data and Safety Monitoring Plan (DSMP) to study symptoms and when the vaginal support was POPQ Stage 0e1. A
the surgical results at the 3e6-month follow-up in this prospective “failed” surgical result was defined as a prolapse with a POPQ Stage
clinical trial. The DSMP is a system for appropriate oversight and
2, even without associated pressure or bulge symptoms.
monitoring of the conduct of a clinical investigation. This oversight
ensures the safety of the participants and the validity and integrity of Surgical procedures
the data. A DSMP should be commensurate with the risks associated
with the investigation and can be as simple as the investigators The principal surgeon (M.J.H.) was proficient in vaginal recon-
annually submitting their safety and Adverse event (AE) information structive surgery with and without mesh. Before this study was
to the Institutional Review Board [13]. Statistical analysis was per- conducted, live surgeries by a key member of the Prosima study
formed to evaluate the factors that may affect the POP treatment investigators (M.P.C.) were observed by M.J.H. and the manufac-
outcome when the Prosima procedure is used. The information turer's instructions for use of the kit were reviewed. The combined
obtained should contribute to the formation of a strategy for the use (anterior and posterior) Prosima procedure was performed on all
of nonanchored vaginal mesh as a means of POP repair. patients. Concomitant surgery for the treatment of a prolapsed
uterus, including vaginal hysterectomy with McCall culdoplasty or
Materials and methods uterine conservation with McCall culdoplasty and partial trache-
lectomy, were carried out if necessary [14]. For the management of
Patients concurrent USI, either overt or occult type, a midurethral sling
(TVT-O, Ethicon) was used. Postoperatively, all patients underwent
Patients were included based on the inclusion and exclusion transurethral bladder drainage. A voiding trial began on post-
criteria described by the Prosima study investigators involved in operative Day 3. A patient's catheter was removed once the patient
previous multicenter studies [11,12]. In brief, women presenting could void freely and the postvoid residual was < 25% of the total
with symptomatic POP
Stage 2 and scheduled for augmented bladder volume on two occasions. The VSD was removed from
reconstructive pelvic surgery at a tertiary hospital were enrolled patients at postoperative Day 25 based on animal studies that have
consecutively in this prospective follow-up study. The exclusion demonstrated that the maximum pullout force of mesh is achieved
criteria included previous prolapse mesh repair, hysterectomy 25 days after implantation [17].
within 6 months of the index surgery, diseases known to affect
bladder or bowel function, and an inability to complete the study. Statistical analysis
All patients gave informed consent for both the surgery and the
study after a full explanation. Approval for this prospective clinical A statistical power calculation was not done because all patients
trial was obtained from the Ethics Committee at our institution (IRB who underwent the Prosima procedure in our institution were
Taichung Veterans General Hospital, TCVGH No. CE11280). A DSMP asked to register as part of this prospective follow-up study. Clinical
investigation was conducted targeting the patients who had data are presented as mean ± standard deviation, median (range),
enrolled during the 1st year of this study from January 2011 through or percentage as appropriate. Univariate analysis was used to
to December 2011. compare the pre- and postoperative POPQ stages for all three
vaginal compartments and the proportion of pelvic symptoms that
Study protocol were present prior to and after surgery. Fifteen important clinical
parameters, namely operation sequence, baseline Ba, C, and Bp
Prior to the surgery, each patient underwent an interview that (anterior, apical, and posterior) values, POPQ stages, age, parity,
included a standard symptom and quality-of-life questionnaire body mass index, diabetes mellitus, chronic constipation, occupa-
[Urogenital Distress Inventory-6 (UDI-6) and Pelvic Organ Prolapse tional/recreational heavy lifting, prior prolapse surgery, concomi-
Impact Questionnaire-7 (POPIQ-7)], a pelvic examination, a cough tant midurethral sling, conservation of the prolapsed uterus, and
stress test with a comfortably full bladder, and a multichannel vaginal mesh exposure, were also compared between the outcome
urodynamic study. The formation and validation of the question- groups by univariate analysis. Additional multivariate logistic
naire that we use in our daily practice and as a research instrument regression analysis was conducted to evaluate the association of
have been detailed previously [14]. The pelvic examination was these clinical variables with surgical outcomes. A p value < 0.05 was
performed with the patients in a 45 upright position in an exam- considered to be statistically significant. All analyses were per-
ining chair while performing the Valsalva maneuver with maximum formed with statistical software SAS version 9.1.3 (SAS Institute Inc,
effort. POP was quantified according to the Pelvic Organ Prolapse Cary, NC, USA).
 C.-P. Tsai et al. / Taiwanese Journal of Obstetrics & Gynecology 53 (2014) 337e342 339

Table 1 Table 3
Preoperative characteristics of the patients who underwent reconstructive pelvic Anatomic outcome assessed by Pelvic Organ Prolapse Quantitation system in pa-
surgery using a nonanchored vaginal mesh procedure (n ¼ 50). tients who underwent reconstructive pelvic surgery using a nonanchored vaginal
mesh procedure at follow-up intervals of 3e6 months (n ¼ 50).
Patient characteristics Value Range
POPQ Baseline Follow-up p
Mean age (y) 60.5 ± 9.3 (38e78)
Median parity (no.) 3 (1e6) Anterior (Ba) site <0.001a
Mean body mass index (kg/m2) 24.9 ± 2.9 (20.0e31.1) Stage 0 0 (0) 40 (80)
Menopause 88 (44/50) Stage I 1 (2) 2 (4)
Prior prolapse repair 8 (4/50) Stage II 17 (34) 8 (16)
Prior hysterectomy 18 (9/50) Stage III 32 (64) 0 (0)
Urodynamic stress incontinence 38 (19/50) Stage IV 0 (0) 0 (0)
Diabetes mellitus 18 (9/50) Apical (C) site <0.001a
Chronic constipation 22 (11/50) Stage 0 1 (2) 42 (84)
Professional/recreational heavy lifting 22 (11/50) Stage I 11 (22) 8 (16)
Stage II 19 (38) 0 (0)
Data are presented as % unless otherwise indicated.
Stage III 15 (30) 0 (0)
Stage IV 4 (8) 0 (0)
Results Posterior (Bp) site <0.001a
Stage 0 2 (4) 48 (96)
Patient characteristics Stage I 9 (18) 2 (4)
Stage II 32 (64) 0 (0)
Stage III 7 (14) 0 (0)
Of the first 52 patients who were enrolled consecutively into Stage IV 0 (0) 0 (0)
this prospective clinical trial, 50 (96%) completed the 3e6-month
Data are presented as n (%).
follow-up evaluation and were assessed accordingly by the DSMP. POPQ ¼ Pelvic Organ Prolapse Quantitation.
Patient characteristics are shown in Table 1. Nine of the 50 patients a
Wilcoxon signed-rank test.
(18%) had undergone a hysterectomy prior to this operation for a
variety of reasons. Only 8% (4 of 50) had undergone prior prolapse who also had a recurrent symptomatic anterior vaginal prolapse,
surgery, which means that most of the patients enrolled in this underwent partial removal of the mesh and anterior colporrhaphy
study were primary POP patients. According to the preoperative in the operating room. The other three patients underwent partial
urodynamic study results, there were 19 patients (38%) with USI (13 mesh excision and were treated with topical estrogen cream at the
overt and 6 occult type, respectively). outpatient clinic.
The anatomic outcomes, as assessed by comparing the preop-
Surgical results erative and postoperative POPQ stages, are shown in Table 3. The
Wilcoxon signed-rank test was used to assess the difference be-
The surgical information had a mean follow-up interval of tween repeated measurements of the POPQ stages prior to and
4.7 ± 1.3 (range 3e6) months and is summarized in Table 2. A total after surgery. The results indicated that, at follow-up, there was a
of eight patients (16%) had recurrent POP Stage 2 in the anterior statistically significant (p < 0.001) improvement in all POPQ mea-
compartment. Among these eight, five remained asymptomatic and surements across the three vaginal compartments.
three had vaginal bulging. Therefore, the objective and subjective The functional outcomes, assessed by comparing the occurrence
success rates of surgery were 84% (42/50) and 94% (47/50), of pre- and postoperative pelvic symptoms and their effect on
respectively. Concomitant USI was cured in 17 patients (89.5%) by quality of life, are shown in Table 4. Statistically significant im-
the use of an additional midurethral sling. Of the 20 patients who provements from baseline were observed in the UDI-6 and POPIQ-7
chose to preserve their uterus, partial trachelectomy was necessary scores as well as in most pelvic symptoms except for defecatory
in six (30%). The complication rates were low. The highest rate was difficulty and dyspareunia.
8% for the four patients having anterior vaginal wall mesh expo-
sure, which was successfully treated in all patients. One patient,
Table 4
Table 2 Functional outcomes assessed by standard symptoms and a quality of life ques-
Surgical results of the patients who underwent reconstructive pelvic surgery using a tionnaire in patients who underwent reconstructive pelvic surgery using a non-
nonanchored vaginal mesh procedure at follow-up intervals of 3e6 months (n ¼ 50). anchored vaginal mesh procedure at follow-up intervals of 3e6 months (n ¼ 50).

Parameters Value Range Pelvic symptoms Baseline Range Follow-up Range p

value value
Basic clinical data
Mean hospital stay (d) 5.3 ± 1.1 (4e9) Vaginal bulging 100 (50/50) 6 (3/50) <0.001a
Mean Foley drainage (d) 3.4 ± 1.1 (3e8) Pelvic pressure 24 (12/50) 2 (1/50) 0.001*
Mean total operation time (min) 134 ± 25.7 (90e190) Urinary urgency 54 (27/50) 16 (8/50) <0.001a
Mean estimated blood loss (mL) 100 ± 150.6 (50e800) Stress urine 26 (13/50) 8 (4/50) 0.007a
Concomitant procedures for prolapsed uterus incontinence
VTH with McCall culdoplasty 51.2 (21/41) Voiding difficulty 42 (21/50) 4 (2/50) <0.001*
McCall culdoplasty with/without trachelectomy 48.8 (20/41) Defecatory 28 (14/50) 22 (11/50) 0.549a
Treatment outcome of POP difficulty
Success (Stage 0e1) 84 (42/50) Dyspareuniab 36.4 (8/22) 26.7 (4/15) 0.500a
Failure (Stage
2) 16 (8/50) UDI-6 5.69 ± 3.23 (0~14) 1.96 ± 1.99 (0~11) <0.001c
Surgical complications POPIQ-7 5.92 ± 4.51 (0~19) 1.48 ± 3.03 (0~17) <0.001c
Retropubic hematoma 2 (1/50)
Data are presented as % or mean ± SD, unless otherwise indicated.
De novo stress urinary incontinence 5.4 (2/37)
POPIQ ¼ Pelvic Organ Prolapse Impact Questionnaire; UDI ¼ urogenital distress
De novo urgency urinary incontinence 4.7 (2/43)
inventory.
Vaginal mesh exposure 8 (4/50) a
McNemar test.
b
Data are presented as % or mean ± SD, unless otherwise indicated. The symptom “dyspareunia” was evaluated in 22 sexually active patients prior
POP ¼ pelvic organ prolapse; USI ¼ urodynamic stress incontinence; VTH ¼ vaginal to surgery and in 15 sexually active patients after surgery.
c
total hysterectomy. Wilcoxon test.
340 C.-P. Tsai et al. / Taiwanese Journal of Obstetrics & Gynecology 53 (2014) 337e342

Outcome association the advantage of avoiding various confounding factors that might
affect the subsequent analysis of associations with surgical
Table 5 shows the results when a comparison of 15 important outcome. By contrast, patients enrolled in previous multicenter
clinical variables across the outcome groups was carried out by studies conducted by the Prosima study investigators underwent a
univariate analysis. In addition, a multivariate logistical regression variety of different Prosima procedures (anterior, posterior, or
analysis was also carried out and this showed that a failed surgical combined) and had the VSD in place for a varying number of days.
outcome (recurrent POPQ stage
2) had a strong association with a In these studies, because of the variations in procedure, it was
preoperative Ba of
þ4 cm (p ¼ 0.039, odds ratio ¼ 20.57), with found that having a VSD in place <21 days was significantly asso-
conservation of a prolapsed uterus (p ¼ 0.045, odds ratio ¼ 10.56), ciated with surgical failure [11,12]. Despite the difference in study
and with the concomitant introduction of a midurethral sling designs, the demographic data for this study and the earlier studies,
(p ¼ 0.039, odds ratio ¼ 0.076). The value of the estimated odds including patient age, parity, menopausal status, and body mass
ratios implies that a severe anterior vaginal prolapse (i.e.,
4 cm index, are similar. Therefore, the higher objective success rate of
beyond the hymen) and conservation of a prolapsed uterus during 84% (POPQ Stage 0e1) in our study compared to 76.9% in the pre-
the surgery predisposes patients to surgical failure using the non- vious multicenter studies may be caused by either the shorter
anchored vaginal mesh procedure (Prosima). By contrast, a follow-up interval (4.7 months vs. 1 year) and/or the uniformly
concomitantly performed midurethral sling procedure seemed to longer VSD placement of 25 days.
augment the suspension effect of the procedure. However, the promising anatomic success rate (84%) in this
study is still inferior to the rates found for trocar-guided vaginal
Discussion mesh kits that are followed up for 3 months (95.3%) [5] and those
involving even longer follow-up intervals (
90%) [6,7,9,10]. The
We developed a DSMP for this prospective clinical trial and lower rate with the Prosima procedure is related to a subgroup of
found that the efficacy and safety of the nonanchored vaginal mesh patients who showed an early anatomic recurrence in the anterior
procedure (Prosima) for treatment of POP was promising when vaginal compartment. This recurrence, after statistical analysis, was
assessed at short-term follow-up. However, eight cases (16%) found to be strongly associated with a preoperative severe anterior
showed an early anatomic recurrence (POPQ Stage 2) in the anterior vaginal wall prolapse at a cutoff Ba value of
þ4 cm. Similar
vaginal compartment, although most of them (5/8) remained findings have been reported in other studies that have analyzed the
asymptomatic. After a statistical analysis, we found that recurrence risk factors associated with POP recurrence after surgery. These
was strongly (p < 0.05) associated with “preoperative severe studies have indicated that the anterior compartment is the most
anterior vaginal wall prolapse” at a cutoff Ba value of
þ4 cm. vulnerable site and patients with more advanced prolapse are more
Meanwhile, two concomitant surgeries, namely “conservation of a likely to experience surgical failure [18,19]. However, this phe-
prolapsed uterus” and the introduction of a “midurethral sling” nomenon is not noted when POP repair is carried by trocar-guided
were related to a negative or positive outcome, respectively, vaginal mesh kits, which are effective in all three vaginal com-
probably because of the suspension effect of each procedure. partments [5e10]. The aforementioned results suggest that the
A homogeneous patient population was enrolled in this study. different vaginal mesh kits each have their own unique design
Most cases (92%) were with primary POP and all of these patients points and these may therefore translate into special indications
underwent the combined (anterior and posterior) Prosima proce- and limitations with respect to POP repair.
dure with a VSD in place for 25 days. This internal consistency has The statistical analysis in this study also demonstrated that two
concomitant surgeries, namely “conservation of a prolapsed
Table 5 uterus” and the “use of a midurethral sling”, had further negative or
Comparison of 15 important clinical variables between outcome groups after positive outcome effects, respectively, on the suspension effect of
reconstructive pelvic surgery using a nonanchored vaginal mesh procedure at
the Prosima procedure. These two procedures involve sites next to
follow-up intervals of 3e6 months (n ¼ 50).
the anterior vaginal segment (bladder base), so it is understandable
Variables Successful (n ¼ 42) Failed (n ¼ 8) p that they would affect any anterior vaginal wall repair. By analyzing
Median operation 23 (2~52) 24 (1~51) 0.711a POPQ data, Rooney et al [20] found that the vaginal apex (C point)
sequence showed a significant correlation with both the anterior (Ba point)
Mean baseline Ba 2.5 ± 2.0 (2~þ6.5) 3.9 ± 1.9 (þ1~þ6.5) 0.056a and the posterior (Bp point) vaginal wall. However, the strength of
point (cm)
Mean baseline C 0.9 ± 3.0 (4~þ8) 0.3 ± 3.3 (6~þ4) 0.537a
the correlation was higher between the C point and the Ba point
point (cm) [20]. Another study conducted by Summers et al [21], who used
Mean baseline Bp 0.1 ± 1.9 (3~þ4.5) 0.6 ± 0.9 (2~þ1) 0.553a dynamic magnetic resonance scanning to determine the degree of
point (cm) displacement of the anterior, apical, and urethral segments during
Median baseline 3 (2~4) 3 (2~3) 0.986a
maximal straining, found that movement of the bladder base was
POPQ stage
Mean BMI (kg/m2) 25 ± 3.0 (20.0~31.1) 24.7 ± 2.0 (21.5~27.3) 0.874a highly correlated with movement of the urethra (r ¼ 0.82) and
Mean age (y) 60.9 ± 9.8 (43~78) 58.9 ± 6.5 (48~67) 0.499a movement of the uterus (r ¼ 0.73). Accordingly, conservation of the
Median parity (no.) 3 (1~6) 3 (1~4) 0.870a prolapsed uterus during the Prosima procedure may place an
Diabetes mellitus 19.1 (8/42) 12.5 (1/8) 1.000b additional burden on the anterior mesh and thus have a negative
Chronic constipation 23.8 (10/42) 12.5 (1/8) 0.666b
Heavy lifting 26.2 (11/42) 0 (0/8) 0.174b
effect on anterior vaginal wall suspension. By contrast, a concom-
Prior prolapse 7.1 (3/42) 12.5 (1/8) 0.514b itant midurethral sling procedure ought to provide a further pro-
surgery tective effect on the anterior repair by adding additional support to
Midurethal sling 42.9 (18/42) 12.5 (1/8) 0.134b the distal segment of the anterior vaginal wall. In fact, Goldberg
Uterine conservation 41.7 (15/36) 100 (5/5) 0.002b
et al [22] found that suburethral sling procedures appeared to
Vaginal mesh 4.8 (2/42) 25 (2/8) 0.115b
exposure significantly reduce the risk of recurrent anterior vaginal wall
prolapse after reconstructive pelvic surgery.
Data are presented as % or mean ± SD, unless otherwise indicated.
POPQ ¼ Pelvic Organ Prolapse Quantification.
In contrast to the early recurrence of the anterior vaginal repair
a
ManneWhitney test. after the Prosima procedure, the optimal effects of apical and
b
Fisher exact test. posterior vaginal repairs are known to be associated with the
 C.-P. Tsai et al. / Taiwanese Journal of Obstetrics & Gynecology 53 (2014) 337e342 341

presence of a variety of confounding factors. One such factor is evaluation of postoperative outcomes. The absence of a comparison
differences in the severity of the prolapse, which may result in group (such as a trocar-guided vaginal mesh kit group) restricts our
different recurrence rates between anterior and posterior vaginal ability to assess the influence of nonfixation of the mesh on POP
wall repairs. In our patients, 64% had a
Stage 3 anterior vaginal repair. The strengths of this study are the homogeneous patient
wall prolapse, but only 14% had a
Stage 3 posterior vaginal wall population, that it is a prospective clinical trial that used stan-
prolapse. Another possible confounding factor is the presence of dardized tools of measurement, and the implementation of a DSMP
additional McCall culdoplasty and partial trachelectomy, which are for the short-term follow-up. Carrying out a DSMP in this study
prolapse repair procedures; these have been noted to affect contributed to the fact that the follow-up was conducted appro-
recurrence rates after POP repair [23]. Both the aforementioned priately ensuring the safety and interest of our patients. At the same
factors may distort the outcome of the Prosima procedure when time, it was especially valuable at the moment because of continual
performed concomitantly. warnings from the United States Food and Drug Administration
Our results showed that USI is able to be successfully treated by regarding adverse events associated with using vaginal mesh [25].
a concomitant midurethral sling and the Prosima procedure. The In conclusion, our findings showed that the nonanchored
89.5% cure rate was compatible with rates for a single procedure. vaginal mesh procedure (Prosima) is safe and produces a favorable
However, the 5% rate of de novo stress incontinence was lower than result in terms of anatomical support and disease-specific quality of
that in studies by Altman et al (12%) [8] and Withagen et al (10%) [9] life at 3e6 months of follow-up. However, we also found that there
after trocar-guided vaginal mesh operations. Low rates of 4e5% was a suboptimal suspension effect of the procedure in the pres-
were also noted in the multicenter studies conducted by the Pro- ence of severe anterior vaginal wall prolapse, which may be further
sima study investigators [11,12]. A prospective and randomized affected by concomitant surgery. The information obtained con-
multicenter trial showed that de novo stress incontinence was cerning surgical outcomes in this study will be helpful to both
significantly more common after trocar-guided vaginal mesh sur- physicians and patients who are planning augmented reconstruc-
gery than after colporraphy. In comparison to baseline urody- tive pelvic surgery using vaginal mesh. We are continuing to follow
namics, vaginal mesh surgery seems to result in a significant this cohort in order to evaluate the longer-term outcomes of the
decrease in maximal urethral closure pressures, whereas conven- Prosima procedure.
tional anterior colporraphy seems to have no significant effect on
urodynamic parameters [24]. The nonanchored vaginal mesh pro- Conflicts of interest
cedure (Prosima), which requires less vaginal dissection together
with the concomitant midurethral sling operation, may explain the The authors have no conflicts of interest relevant to this article.
low rate of de novo stress incontinence [11,12]. Although meta-
analysis has revealed that concurrent continence surgery at the
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