Original Research
Permanent Compared With Absorbable
Suture for Vaginal Mesh Fixation During Total
Hysterectomy and Sacrocolpopexy
A Randomized Controlled Trial
Catherine A. Matthews, MD, Elizabeth J. Geller, MD, Barbara R. Henley, MD, Kimberly Kenton,
Erinn M. Myers, MD, Alexis A. Dieter, MD, Brent Parnell, MD, Christina Lewicky-Gaupp, MD,
Margaret G. Mueller, MD, and Jennifer M. Wu, MD MPH
Downloaded from http://journals.lww.com/greenjournal by BhDMf5ePHKbH4TTImqenVE17rCHCwnx1fETcK+XZ3Wn3Ri1v036kA6fm40zpHP6p on 08/02/2020
OBJECTIVE: To compare mesh and permanent suture
exposure rates in the first year after minimally invasive
total hysterectomy and sacrocolpopexy with a light-
weight polypropylene mesh using permanent or delayed
absorbable sutures.
METHODS: Across five centers in the United States,
women were randomized to permanent or delayed
absorbable suture for vaginal attachment of a Y-mesh
during hysterectomy and sacrocolpopexy for stage II
prolapse and worse. The primary outcome was mesh or
permanent suture exposure in the first year after surgery.
The secondary outcome was to compare a composite
measure for success defined as leading edge of prolapse
not beyond the hymen and apex not descended more
than one third vaginal length, and no subjective bulge
From the Department of Urology, Wake Forest Baptist Health, Winston Salem,
and the Department of Obstetrics and Gynecology, University of North Carolina
at Chapel Hill, Chapel Hill, North Carolina; Augusta University, Augusta,
Georgia; Northwestern Feinberg School of Medicine, Chicago, Illinois; and
Atrium Health, Charlotte, North Carolina.
Accepted for presentation at the Society of Gynecologic Surgeon’s 46th Annual
Scientific Meeting, July 6–9, 2020, Jacksonville, Florida, and at the Interna-
tional Urogynecological Association’s 45th Annual Meeting, September 2–5,
2020, The Hague, The Netherlands.
The authors thank Dr. Karen Noblett and Dr. Michael Flynn for voluntarily
serving on the Data Safety and Monitoring Board for this study.
Corresponding author: Catherine A. Matthews, MD, Department of Urology,
Wake Forest Baptist Health, Winston Salem, NC 27101; email: camatthe@
wakehealth.edu.
Financial Disclosure
Catherine A. Matthews, Kimberly Kenton, and Margaret Mueller are consultants
for Boston Scientific Corporation and expert witnesses for defense, Johnson &
Johnson. Barbara Henley is a consultant for Allergan. Margaret Mueller disclosed
that she received funds from Butler Snow. The other authors did not report any
potential conflicts of interest.
© 2020 by the American College of Obstetricians and Gynecologists. Published
by Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0029-7844/20
VOL. 136, NO. 2, AUGUST 2020
© 2020 by the American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
MD, MS,
and no prolapse retreatment. Patients completed a pelvic
examination including the pelvic organ prolapse quanti-
fication system and questionnaires at baseline, 6 weeks
and 1 year postsurgery. A sample size of 80 per group
was planned to compare the rate of mesh or permanent
suture exposure in the permanent compared with
delayed absorbable groups.
RESULTS: From April 2015 to May 2019, 204 patients
(n5102 permanent; n5102 delayed absorbable) were
randomized. One hundred ninety-eight women had
follow-up data, with 182 (93%) completing 1-year
follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%)
delayed absorbable. The total rate of mesh or permanent
suture exposure was 12 of 198 (6.1%): 5.1% for perma-
nent compared with 7.0% for delayed absorbable (risk
ratio 0.73, 95% CI 0.24–2.22). The majority (9/12) were
asymptomatic. Composite success was 93% for perma-
nent compared with 95% for delayed absorbable suture,
P5.43). Six (3.0%) women had a serious adverse event.
CONCLUSION: Suture type used for vaginal graft
attachment did not influence mesh or permanent suture
exposure rates.
FUNDING SOURCE: Boston Scientific Corporation.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov,
NCT02277925.
(Obstet Gynecol 2020;136:355–64)
DOI: 10.1097/AOG.0000000000003884
S
ymptomatic pelvic organ prolapse is common and
13%1 to 19%2 of women undergo surgical repair.
Abdominal sacrocolpopexy is considered to be the
most durable operation for advanced pelvic organ
prolapse with reoperation rates of less than 5%.3
Although traditionally reserved for women with vag-
inal vault prolapse, sacrocolpopexy is increasingly
OBSTETRICS & GYNECOLOGY 355
considered as a primary surgical option for women
who present with uterovaginal prolapse in an attempt
to improve longer-term surgical outcomes.4 Mini-
mally invasive techniques of sacrocolpopexy are asso-
ciated with improved recovery times and less cost
than the abdominal route without a demonstrable dif-
ference in efficacy.5
Vaginal mesh exposure is the most commonly
identified mesh complication of sacrocolpopexy with
widely disparate rates ranging from 0%6 to 27%.7 Risk
factors include non–type 1 polypropylene mesh,8
smoking and concomitant total hysterectomy that
has been associated with a twofold to sevenfold
increased risk (8.2–12%).9,10 Lighter weight type 1
polypropylene mesh materials and absorbable sutures
for mesh attachment may be associated with lower
risks of mesh exposure. Geller et al11 reported an
8% risk of long-term mesh exposure using a perma-
nent suture for mesh attachment during sacrocolpo-
pexy with and without concomitant total
hysterectomy with a nonlight weight y-mesh. In con-
trast, a retrospective review of 67 women undergoing
total abdominal hysterectomy and sacrocolpopexy
with absorbable suture and a lighter weight mesh re-
ported no mesh exposures.12
The use of permanent sutures for vaginal mesh
attachment has historically been advocated as a means
of reducing prolapse recurrence risk; yet, no pro-
spective study has definitively answered this question.
There is a need to identify the ideal method of vaginal
mesh attachment that minimizes the risk of mesh-
related complications while maintaining effectiveness
of the prolapse repair. The primary aim of PACT
(Permanent versus Absorbable Controlled Trial),
therefore, was to test the hypothesis that use of the
Upsylon mesh (Y-mesh) with a delayed absorbable
suture for vaginal mesh attachment at the time of
robotic or total laparoscopic hysterectomy and sacro-
colpopexy will reduce the risk of vaginal mesh and
permanent suture exposure compared with a perma-
nent monofilament suture. Our secondary aim was to
compare composite success rates.
ROLE OF THE FUNDING SOURCE
Boston Scientific Corporation provided funding for
this clinical trial after submission through their online
Investigator-Sponsored Research Program. Our pro-
tocol was developed independently from the com-
pany and they had no input regarding study design,
implementation, data collection, or analysis. Boston
Scientific has no rights to the data that were indepen-
dently maintained through the data control center at
the University of North Carolina. The authors had
356 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy
© 2020 by the American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
complete access to relevant aggregated study data and
other information (such as study protocol, analytic
plan and report, validated data table, and clinical
study report) required to understand and report
research findings. The authors take responsibility for
the presentation and publication of the research
findings, have been fully involved at all stages of
publication and presentation development, and are
willing to take public responsibility for all aspects of
the work. All individuals included as authors and
contributors who made substantial intellectual contri-
butions to the research, data analysis, and publication
or presentation development are listed appropriately.
The role of the sponsor in the design, execution,
analysis, reporting, and funding is fully disclosed. The
authors’ personal interests, financial or nonfinancial,
relating to this research and its publication have been
disclosed.
METHODS
This protocol adheres to the CONSORT (Consoli-
dated Standards of Reporting Trials) guidelines for
performing and reporting randomized controlled
trials.13 PACT is a randomized, single-blind con-
trolled clinical trial that was conducted at five clinical
sites: Wake Forest Baptist Health, University of North
Carolina, Northwestern Memorial Health Care, Au-
gusta University, and Atrium Health between April
2015 and May 2019. Institutional Review Board
approval was obtained at each clinical site. The pri-
mary aim was to compare vaginal mesh or permanent
suture exposure rates in women
undergoing minimally invasive total hysterectomy
and sacrocolpopexy with a lightweight polypropylene
mesh using permanent sutures (Gore-Tex [2-0 polyte-
trafluoroethylene]) compared with delayed absorb-
able monofilament sutures (PDS [2-
0 polydioxanone]) within 1 year postoperatively.
Mesh exposure was defined as “vaginal mesh visual-
ized through separated vaginal epithelium” according
to the International Urogynecological Association/
International Continence Society joint classification
system.14 The secondary aim was to compare the 1-
year composite success rate between groups that was
defined as: 1) leading edge of prolapse not beyond the
hymen and apex not descended more than one-third
total vaginal length, 2) no subjective symptoms of
bothersome vaginal bulge on the Pelvic Floor Distress
Inventory-20,15 and 3) no prolapse retreatment. Entry
criteria included stage II or worse symptomatic utero-
vaginal prolapse using the pelvic organ prolapse
quantification (POP-Q) system16 and a clinical indica-
tion for minimally invasive total hysterectomy and
OBSTETRICS & GYNECOLOGY
sacrocolpopexy. Patients had to report a bothersome
bulge they could see or feel per Pelvic Floor Distress
Inventory-20 question 3, response of 2 or higher (ie,
responses of “somewhat,” “moderately,” or “quite
a bit” of bother). Patients with systemic connective
tissue diseases, chronic systemic pain syndromes,
poorly controlled diabetes (hemoglobin A1C greater
than 9) or those requiring concomitant rectopexy
were excluded.
Randomization to 2-0 polytetrafluoroethylene
(permanent group) or 2-0 polydioxanone suture
(delayed absorbable group) was performed using
computer-generated random numbers in variable
block sizes of 2, 4, and 6, with 1:1 treatment
allocation. Groups were stratified by clinical site.
The assignment was determined in the operating
room immediately before mesh graft attachment.
The women and research staff were unaware of the
treatment assignment and blinding was maintained
until the 1-year follow-up visit.
After research consent and enrollment, the fol-
lowing baseline and follow-up data were obtained at
scheduled intervals: demographic information, medi-
cal history and medications, and physical examination
including complete pelvic examination and POP-Q
assessment. Patients completed standardized, de-
identified, and validated symptom bother, sexual
function, and quality-of-life questionnaires that
included the Pelvic Floor Distress Inventory-20, the
Pelvic Floor Impact Questionnaire-7, and the Pelvic
Organ Prolapse/Incontinence Sexual Questionnaire,
IUGA-Revised.17
All patients underwent total laparoscopic hyster-
ectomy with or without bilateral salpingo-
oophorectomy (at the discretion of the patient and
surgeon) before laparoscopic sacrocolpopexy, with or
without robotic assistance. Uteri were delivered
through the vagina and no power morcellation was
performed. Surgeon preference determined the
method of vaginal cuff closure and included inter-
rupted compared with continuous sutures using
barbed, monofilament or braided absorbable suture
material. Upsylon mesh was used for all study
participants. Upsylon is a preformed type I poly-
propylene Y-mesh that is light-weight (25 g/m2) with
a pore size of 2.8 mm2 and surface area ratio of 1.11. It
was approved by the U.S. Food and Drug Adminis-
tration in 2012. The blue color of the mesh may aide
in the ability to detect even small areas of mesh expo-
sure and erosion. Vaginal mesh attachment extended
for a distance of at least 4 cm on the anterior and
posterior vaginal walls using at least four sutures on
each side according to study assignment. The anterior
VOL. 136, NO. 2, AUGUST 2020 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy 357
© 2020 by the American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
graft could not extend beyond the urethrovesical junc-
tion. The posterior graft could extend toward the per-
ineal body but was not anchored into the perineal
body. The sacral arm of the mesh was attached
directly to the anterior longitudinal ligament at the
sacral promontory using at least two permanent su-
tures (2-0 polytetrafluoroethylene or Prolene). Perito-
neal closure over the mesh was recommended but was
not required. Optional additional procedures
included any full-length, mid-urethral sling for treat-
ment or prevention of stress incontinence that was
placed through a separate vaginal incision; retropubic
urethropexy; and distal posterior colporrhaphy per
surgeon discretion. All intraoperative study variables,
including intraoperative complications, were
recorded.
Symptomatic and anatomic improvement of pel-
vic organ prolapse was evaluated at the 6-week and 1-
year postoperative visits. A blinded examiner com-
pleted the POP-Q and pelvic examinations. Any mesh
that was visible in the vagina was reported. Permanent
suture material that was visible in the vagina beyond
12 weeks was reported. Study questionnaires were
repeated at the 1-year postoperative visit. A phone
call was administered at 6 months to assess for
complications. Postoperative complications were cat-
egorized using the Clavien-Dindo surgical complica-
tion grading scale.18
Based on prior data, we estimated the mesh
exposure rate among women in the control group
(permanent suture) to be 10%.7,11 We estimated that,
if the mesh exposure rate for experimental partici-
pants (absorbable suture) was 1%,12 and based on
a one-sided test, we would need 80 patients per group
at a power of 0.8 and an alpha of 0.10. We planned to
enroll 200 patients to account for up to 20% loss to
follow-up.
Both an intention-to-treat (ITT) and per-protocol
analysis were performed. We defined the ITT pop-
ulation as those women who had at least one post-
operative vaginal examination at or beyond 6 weeks,
whereas the per-protocol analysis population were
those women who returned at 1 year postoperatively.
For the ITT analysis for the primary outcome and
composite success, we used the last observation
carried forward; then, we also evaluated the results
assuming that all missing data were successes com-
pared with assuming that all missing data were failures
to assess differences between the two groups. Means
and SDs or counts and percentages were computed
for continuous and categorical data, respectively.
Student’s t test, x2 test, or Fisher exact test were used
where appropriate. Differences were considered
statistically different where P#.05. All analyses were
performed using IBM SPSS 26.0.
RESULTS
Two hundred four patients were randomized (n5102
permanent suture, n5102 delayed absorbable suture).
Three women in the permanent suture arm (random-
ized early, then determined to be ineligible before
intervention) and one in the delayed absorbable
suture arm (converted to vaginal surgery after ran-
domization owing to complications) did not receive
the allocated intervention leaving 99 in the permanent
and 101 in the delayed absorbable suture groups who
received the intervention, respectively, for analysis
(Fig. 1).
Overall, 182 women (93%) completed 1-year
follow-up: 95 of 99 (96%) in the permanent compared
with 87 of 101 (86%) in the delayed absorbable suture
group. Four patients in the permanent suture group
were excluded from the per-protocol analysis: one did
not attend any postoperative follow-up visits despite
multiple contact attempts, two completed the 6-week
and 6-month phone call but not the 1-year visit, and
one voluntarily withdrew when she moved out of the
country. In the delayed absorbable suture group, 14
women were excluded from per-protocol analysis: 12
were lost to follow-up (one at 6 months and 11 at 1
year) and two patients voluntarily withdrew (one at 6
weeks likely owing to complications from ureteral
injury and urosepsis and one as a result of trans-
portation issues) (Fig. 1).
The preoperative characteristics are presented in
Table 1 and were similar between groups. The mean
age was 59 years, and the majority were white
(90.5%), privately insured (78.5%), and postmeno-
pausal without the use of any hormones (58.5%).
Almost 75% of the cohort had Stage III or IV
prolapse.
The ITT analysis found no difference for any
mesh or permanent suture exposure through 1 year
between groups using the last observation carried
forward. The total rate of mesh or permanent suture

Fig. 1. CONSORT (Consolidated Standards of Reporting Trials) flow diagram, permanent vs absorbable controlled trial.
*Patient was not randomized in operating room, surgeon unable to perform sacrocolpopexy.
Matthews. Suture Type for Vaginal Graft Attachment During Sacrocolpopexy. Obstet Gynecol 2020.

358 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy OBSTETRICS & GYNECOLOGY

© 2020 by the American College of Obstetricians

and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
Table 1. Demographics, Clinical Characteristics, and Baseline Pelvic Floor Disorders Questionnaire Data

Characteristic Permanent Suture [n599 (49.5)] Delayed Absorbable Suture [n5101 [50.5)]

Age (y) 59.7610.7 59.0610.2

Hispanic ethnicity 14 (14) 11 (11)
Race
White 91 (92) 90 (89)
African American 7 (7) 8 (8)
Other 1 (1) 3 (3)
Insurance status
Private insurance 82 (83) 75 (74)
Medicaid or Medicare 29 (29) 29 (28)
Uninsured 2 (2) 5 (5)
Charlson comorbidity index 0 (0–6) 0 (0–3)
Parity (median, IQR) 2 (2, 3) 2 (2, 3)
Menopausal status
Premenopausal or perimenopausal 24 (24) 24 (24)
Postmenopausal, no hormones 60 (61) 57 (56)
Postmenopausal, vaginal estrogen 12 (12) 13 (13)
Postmenopausal, oral hormones 3 (3) 7 (7)
Smoking status
Never 64(65) 73 (72)
Prior smoker 33(33) 25 (25)
Current smoker 2(2) 3 (3)
Prior vaginal prolapse surgery with mesh 1(1) 1 (1)
Prior vaginal surgery without mesh 2(2) 4 (4)
Prior abdominal POP surgery with mesh 0 0
Prior abdominal POP surgery without mesh 1 (1) 0
Prior Burch urethropexy 0 1 (1)
Prior sling 2 (2) 2 (2)
BMI (kg/m2) 27.565.0 27.564.7
Preoperative POP-Q stage
0 or I 0 0
II 27 (27.3) 28 (27.7)
III 57 (57.6) 65 (64.4)
IV 15 (15.2) 8 (7.9)
Preoperative POP-Q points (median, IQR)
Aa 2 (0, 3) 2 (0, 3)
Ba 2 (0, 4) 2 (1, 3.25)
C 0 (23, 3) 0 (23, 2.75)
D 24 (25, 21) 23 (25, 21)
Ap 21 (22, 0) 21 (22, 0)
Bp 21 (22, 0) 21 (22, 0)
TVL 9 (8.5, 10) 9 (8, 10)
GH 4.5 (4, 5.5) 4 (4, 5)
PB 3 (2, 3.5) 3 (2, 3)
PFDI-20 total score 106643 115651
POPDI-6 subscale 49621 51623
UDI-6 subscale 33626 35628
CRAD-8 subscale 24619 29620
PFIQ-7 total score 45648 61663
POPIQ-7 subscale 16619 23628
UIQ-7 subscale 19624 25623
CRAIQ-7 subscale 9616 14621
IQR, interquartile range; POP, pelvic organ prolapse; BMI, body mass index; POP-Q, pelvic organ prolapse quantification; TVL, total vaginal
length; GH, genital hiatus; PB, perineal body; PFDI-20, Pelvic Floor Distress Inventory Short Form; POPDI-6, Pelvic Organ Prolapse
Distress Inventory-6; UDI-6, Urinary Distress Inventory, Short Form; CRAD-8, Colorectal–Anal Distress Inventory-8; PFIQ-7, Pelvic Floor
Impact Questionnaire Short Form; POPIQ-7, Pelvic Organ Prolapse Impact Questionnaire; UIQ-7, Urinary Impact Questionnaire;
CRAIQ-7, Colorectal–Anal Impact Questionnaire.
Data are mean6SD, n (%), or median (range) unless otherwise specified.

VOL. 136, NO. 2, AUGUST 2020 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy 359

© 2020 by the American College of Obstetricians

and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
exposure was 12 of 198 (6.1%): 5 of 98 (5.1%) for
permanent compared with 7 of 100 (7.0%) for delayed
absorbable (risk ratio 0.73, 95% CI 0.24–2.22). For the
per-protocol analysis, the total rate of any mesh or
permanent suture exposure within 1 year postopera-
tively was 12 of 182 (6.6%); there was no difference
between the two groups (5/95 [5.3%] permanent vs
7/87 [8.0%] delayed absorbable, risk ratio 0.65, 95%
CI 0.22–1.99) when evaluating those with 1-year
follow-up data (Table 2). There were 10 mesh-only
exposures, two mesh and permanent suture expo-
sures, and no permanent suture–only exposures.
Overall, 9 of 12 (75%) mesh exposures were noted at
the vaginal apex, 2 of 12 (16.7%) were posterior, and 1
of 12 (8.3%) was anterior. The majority of patients
(9/12) were asymptomatic; the remaining 3 of 12 had
vaginal bleeding, discharge, or both. Mesh and suture
exposures were managed as follows: four (33%) no
treatment, six (59%) vaginal estrogen, one (8%) office
trimming, and one (8%) vaginal mesh excision
surgery.
Baseline Pelvic Floor Distress Inventory-20 data
are presented in Table 1. On study entry, women in
the delayed absorbable suture group had a higher
PFIQ-7 total score and POP-IQ subscale score, indi-
cating more prolapse-related effects on their activities
of daily living. There was no difference in the degree
of bother of their pelvic floor symptoms, based on
Pelvic Floor Distress Inventory-20 total and subscale
scores.

Table 2. Outcome Data for the Per-Protocol Analysis

Permanent Suture Delayed Absorbable Suture

Outcome Data (n595/99) (n587/101) P

Follow-up time (mo) 12.361.4 12.561.0 .27

Any mesh or suture exposure through 1 y, PPA 5/95 (5.3) 7/87 (8.0) .45
Any mesh exposure through 1 y 5 (5.3) 7 (8.0) .45
Any suture exposure through 1 y 2 (2.1) 0 .50
Vaginal discharge or bleeding 2 (2.1) 2 (2.3) .93
Treatment for mesh or suture exposure .43
No treatment 1 (20.0) 3 (42.8)
Vaginal estrogen 3 (60.0) 3 (42.8)
Trim in office 0 1 (12.5)
Surgery 1 (20.0) 0
Composite success at 1 y 88/95 (92.6) 83/87 (95.4) .43
PFDI-20 question 3 .43
No symptoms 82 (86.3) 81 (93.1)
Not at all bothered 6 (6.3) 2 (2.2)
Somewhat bothered 4 (4.2) 3 (3.4)
Moderately bothered 2 (2.1) 0
Quite a bit bothered 1 (1.0) 1 (1.1)
PFDI-20 question 3 .43
No symptoms or not at all bothered 88 (92.6) 83 (95.4)
Somewhat, moderately or quite a bit bothered 7 (7.4) 4 (4.6)
Retreatment with pessary for POP 1 (1.1) 0 .33
Repeat surgery for POP 0 0
POP stage at 1 y .99
0 29 (30.5) 26 (29.9)
I 46 (48.4) 44 (50.6)
II 18 (18.9) 15 (17.2)
III 2 (2.1) 2 (2.3)
IV 0 0
Postop POP-Q points
Aa 23 (23, 22) 23 (23, 22)
Ba 23 (23, 22) 23 (23, 22)
C 29 (210, 28) 28.5 (29, 28)
Ap 22.5 (23, 22) 23 (23, 22)
Bp 22.5 (23, 22) 23 (23, 22)
TVL 9 (8.5, 10) 9 (8, 10)
PPA, per-protocol analysis; PFDI-20, Pelvic Floor Distress Inventory Short Form; POP, pelvic organ prolapse; POP-Q, pelvic organ prolapse
quantification; TVL, total vaginal length.
Data are mean6SD, n/N (%), n (%), or median (interquartile range) unless otherwise specified.

360 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy OBSTETRICS & GYNECOLOGY

© 2020 by the American College of Obstetricians

and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
 Surgical characteristics and concomitant proce-
dures are presented in Table 3. Overall, 75.5% of
cases were performed with robotic assistance, with
no difference between groups. There were no differ-
ences in concomitant procedures, surgical times,
learner involvement, estimated blood loss, length
of stay, postoperative retention, or complications
between groups. The most common intraoperative
complications were cystotomy (2%) and vaginoto-
my (2%). There were no intraoperative bowel or
vascular injuries. There was one ureteral injury that
was detected on cystoscopy at the termination of the
procedure that resulted in ureteral stent placement
and laparoscopic repair. There were three protocol
deviations in which the Upsylon mesh was not used
and a substitute ultra-lightweight y-mesh was im-
planted, two in the permanent suture group and
one in the delayed absorbable suture group, and
none of these participants had mesh or suture
complications.

Table 3. Surgery and Postoperative Characteristics

Permanent Suture Delayed Absorbable Suture

Operative Characteristics [n599 (49.5)] [n5101 (50.5)] P

Robotic-assisted 77 (78) 74 (73) .46

Bilateral salpingo-oophorectomy 59 (60) 58 (57) .76
Bilateral salpingectomy 33 (33) 44 (44) .13
Vaginal posterior repair 43 (43) 43 (44) .90
Robotic or laparoscopic urethropexy 7 (7) 6 (6) .75
Midurethral sling 54 (55) 54 (55) .99
Retropubic 52 (96) 50 (93) .40
Estimated blood loss (mL) 93680 102687 .45
Time for vaginal graft attachment (min) 34628 38623 .22
Total time for procedure (min) 213670 225669 .21
Intraoperative complications 10 (10) 5 (5) .17
Bladder injury 2 (2) 2 (2)
Rectal injury 1 (1) 0
Vaginotomy 3 (3) 1 (1)
Ureteral injury 0 1 (1)
Ureteral kinking, resolved with cuff sutures release 1 (1) 0
Stitch through anterior vaginal wall 1 (1.0) 1 (1)
Passed void trial before discharge 61 (62) 66 (65) .58
Length of stay (d) .61
0 18 (18) 18 (18)
1 81 (82) 82 (81)
2 0 1 (1)
Fellow assist with hysterectomy 42 (42) 45 (45) .76
Fellow assist with colpopexy 45 (46) 48 (48) .77
Resident assist with hysterectomy 59 (60) 63 (62) .69
Residency assist with colpopexy 24 (24) 25 (25) .93
Closure of peritoneal bladder flap 77 (78) 77 (76) .80
Closure of presacral peritoneum 76 (77) 77 (76) .93
No. of sutures for anterior mesh fixation 6 (6, 7) 6 (5, 7) .12
No. of sutures for posterior mesh fixation 6 (5, 8) 6 (5, 8) .99
Vaginal cuff sutures .63
Interrupted 34 (34) 38 (38)
Continuous 65 (66) 63 (62)
Cuff suture type .39
Barbed monofilament absorbable suture 70 (71) 70 (69.3)
Polydioxanone suture 14 (14) 20 (19.8)
Polyglactin 910 8 (8) 9 (8.9)
Serious postoperative complications (Dindo grade) .37
Urosepsis (IVA) 0 1 (1)
Infected hematoma (II) 0 1 (1)
Pulmonary embolism (II) 0 1 (1)
Port site hernia (IIIB) 0 1 (1)
Small bowel obstruction (IIIB) 1 (1) 0
Data are n (%), mean6SD, or median (interquartile range) unless otherwise specified.

VOL. 136, NO. 2, AUGUST 2020 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy 361

© 2020 by the American College of Obstetricians

and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
 For composite success at 1 year, the rates were
high for both groups, with no difference between
groups (92.8% for permanent suture vs 96.0% for
delayed absorbable suture, P5.33 for the ITT analysis
with the last observation carried forward, and 92.6%
vs 95.4%, P5.43, respectively, for the per-protocol
analysis). We also assumed that all missing data were
either successes or failures to evaluate any differences
in composite success between groups, and there re-
mained no differences (Table 2). There was a low rate
of bothersome bulge symptoms in each group and no
difference between groups (7.4% for permanent suture
vs 4.6% for delayed absorbable suture, P5.43). Over-
all, 2% failed by anatomic definition, 6% by bulge
symptoms, and 0.5% by retreatment with a pessary.
There were no repeat surgeries for prolapse recur-
rence. Overall, six (3.0%) women had a serious post-
operative adverse event with no differences between
groups (Table 3).
DISCUSSION
In this study, we found that the use of an absorbable
suture for vaginal mesh attachment during minimally
invasive total hysterectomy and sacrocolpopexy
did not reduce the risk of vaginal mesh or perma-
nent suture exposure or compromise procedural
efficacy compared with permanent suture within 1-
year postsurgery. Ninety-four percent of study
participants met a rigid, composite definition of
success despite the majority having advanced pre-
operative uterovaginal prolapse, a strong risk factor
for prolapse recurrence.19 Overall mesh or perma-
nent suture exposure rates were 6%, but only one
patient required surgical revision. Our data suggest
that total hysterectomy with sacrocolpopexy is safe
and efficacious with low rates of reoperation for
mesh or suture complications if either delayed
absorbable suture or permanent suture is used for
vaginal mesh fixation. Surgeons can feel comfort-
able selecting suture for vaginal fixation based on
costs, preference, or individualized patient factors
without fear of increasing mesh exposure or surgi-
cal failure. These data cannot, however, be extrap-
olated to include all suture types such as braided
permanent suture that has been associated with
higher rates of mesh exposure.20
This is an adequately powered, randomized trial
specifically designed to investigate the effects of
suture type on mesh exposure risk in women
undergoing concomitant total hysterectomy, an
independent risk factor for mesh complications,8–10
362 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy
© 2020 by the American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
at the time of sacrocolpopexy. Other trials reporting
mesh exposure rates for sacrocolpopexy have
included a heterogeneous mix of women with apical
prolapse that include a larger percentage of vaginal
vault as compared with uterine prolapse, thereby
underestimating risk of mesh complications in
women having total hysterectomy at the time of
sacrocolpopexy.3,21,22 Furthermore, most studies in
women with primary uterine prolapse have included
women undergoing supracervical as opposed to
total hysterectomy.22,23 Total hysterectomy has
been associated with higher rates of mesh exposure
using standard weight mesh,8 but there are no direct
comparative studies with light-weight mesh. The
majority of our observed mesh exposures did occur
at the site of the colpotomy and leaving the cervix in
situ would likely reduce this risk. There are poten-
tial negative consequences of a supracervical hyster-
ectomy, however, including morcellation of
unanticipated uterine malignancy,24 cervical stump
prolapse or elongation, cyclic vaginal bleeding, and
higher prolapse recurrence risk in the anterior
compartment.25
The specific type of mesh material likely has
a far greater effect on mesh complications and
procedural efficacy than the mechanism by which it
is attached to the vagina. In a multicenter study of
open sacrocolpopexy in which half of procedures
were done with woven polyester or expanded poly-
tetrafluoroethylene and half with heavier, stiffer, and
less porous polypropylene meshes (Gynemesh; Ethi-
con’s Women’s Health and Urology, Cincinnati,
Ohio) than was used in our study, rates of mesh
exposure increased to 10.5% by 6 years postsurgery.3
In contrast, ultra-lightweight polypropylene mesh
(Alyte Y-mesh and Restorelle Y Smartmesh) has
been associated with very low rates of mesh exposure
but has not been prospectively studied with concom-
itant total hysterectomy.22,26 One retrospective study
reported an almost fivefold increased risk of early
anterior compartment failure with the use of an
ultra-lightweight as compared with heavier weight
mesh. Upsylon, which is categorized as a lightweight
mesh, appears to have balanced shorter-term efficacy
and risk.27
Our study is strengthened by the prospective,
randomized design with an adequate sample size of
women with advanced primary uterovaginal prolapse.
Use of the same mesh material in all but three cases
allowed us to independently assess the effect of suture
material for mesh and suture erosion and success
OBSTETRICS & GYNECOLOGY
rates. We had a relatively low rate of loss to follow-up
and assessed different assumptions regarding missing
data to determine whether those lost to follow-up
would affect our results.
A study limitation includes the lack of standard-
ization of vaginal cuff closure techniques, a variable
that may affect mesh exposure rates. However, this
expands the generalizability of the results to routine
clinical practice in which various absorbable sutures
and techniques are used for vaginal cuff closure.
Another limitation is the relatively short follow-up
period of 1 year. We recognize that mesh exposure
rates can increase over time and longitudinal follow-
up is planned, although any significant effect from
suture type would likely be seen within the first year.
Finally, the presence of industry funding for this study
could have introduced bias despite every attempt to
separate the funding source from the investigators and
study.
In conclusion, mesh or permanent suture expo-
sure rates and clinical success after minimally invasive
total hysterectomy and sacrocolpopexy for primary
advanced uterovaginal prolapse are not affected by
suture type for vaginal graft attachment. The use of
a lightweight mesh material resulted in a low rate of
symptomatic mesh exposure, a high rate of success,
and few serious adverse events within 1-year postsur-
gery. These findings can help surgeons when coun-
seling women regarding mesh surgical procedure
options for the primary treatment of advanced utero-
vaginal prolapse.
REFERENCES
1. Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M.
Lifetime risk of stress urinary incontinence or pelvic organ pro-
lapse surgery. Obstet Gynecol 2014;123:1201–6.
2. Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of
undergoing surgery for pelvic organ prolapse. Obstet Gynecol
2010;116:1096–100.
3. Nygaard I, Brubaker L, Zyczynski HM, Cundiff G, Richter H,
Gantz M, et al. Long-term outcomes following abdominal sac-
rocolpopexy for pelvic organ prolapse. JAMA 2013;309:2016–
24.
4. Wang LC, Al Hussein Al Awamlh B, Hu JC, Laudano MA,
Davison WL, Schulster ML, et al. Trends in mesh use for pelvic
organ prolapse repair from the medicare database. Urology
2015;86:885–91.
5. Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C.
Laparoscopic and abdominal sacral colpopexies: a comparative
cohort study. Am J Obstet Gynecol 2005;192:1752–8.
6. Borahay MA, Oge T, Walsh TM, Patel PR, Rodriguez AM,
Kilic GS. Outcomes of robotic sacrocolpopexy using barbed
delayed absorbable sutures. J Minim Invasive Gynecol 2014;
21:412–16.
7. Culligan PJ, Murphy M, Blackwell L, Hammons G, Graham
C, Heit MH. Long-term success of abdominal sacral colpo-
VOL. 136, NO. 2, AUGUST 2020 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy 363
© 2020 by the American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
pexy using synthetic mesh. Am J Obstet Gynecol 2002;187:
1473–80.
8. Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager
CW, Norton PA, et al. Risk factors for mesh/suture erosion
following sacral colpopexy. Am J Obstet Gynecol 2008;199:
688.e681–5.
9. Akyol A, Akca A, Ulker V, Gedikbasi A, Kublay A, Han A,
et al. Additional surgical risk factors and patient characteristics
for mesh erosion after abdominal sacrocolpopexy. J Obstet Gy-
naecol Res 2014;40:1368–74.
10. Bensinger G, Lind L, Lesser M, Guess M, Winkler HA.
Abdominal sacral suspensions: analysis of complications using
permanent mesh. Am J Obstet Gynecol 2005;193:2094–8.
11. Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term out-
comes of robotic sacrocolpopexy compared with abdominal
sacrocolpopexy. Obstet Gynecol 2008;112:1201–6.
12. Marinkovic SP. Will hysterectomy at the time of sacrocolpo-
pexy increase the rate of polypropylene mesh erosion? Int Ur-
ogynecol J Pelvic Floor Dysfunct 2008;19:199–203.
13. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement:
updated guidelines for reporting parallel group randomized tri-
als. Ann Intern Med 2010;152:726–32.
14. Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW,
Deprest J, et al. An International Urogynecological Association
(IUGA)/International Continence Society (ICS) joint terminol-
ogy and classification of the complications related directly to
the insertion of prostheses (meshes, implants, tapes) and grafts
in female pelvic floor surgery. Neurourol Urodyn 2011;30:2–
12.
15. Barber MD, Walters MD, Bump RC. Short forms of two
condition-specific quality-of-life questionnaires for women with
pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gy-
necol 2005;193:103–13.
16. Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO,
Klarskov P, et al. The standardization of terminology of female
pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet
Gynecol 1996;175:10–7.
17. Rogers RG, Rockwood TH, Constantine ML, Thakar R, Kam-
merer-Doak DN, Pauls RL, et al. A new measure of sexual
function in women with pelvic floor disorders (PFD): the Pelvic
Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-
Revised (PISQ-IR). Int Urogynecol J 2013;24:1091–103.
18. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D,
Schulick RD, et al. The Clavien-Dindo classification of surgical
complications: five-year experience. Ann Surg 2009;250:187–
96.
19. Aslam MF, Osmundsen B, Edwards SR, Matthews C, Gregory
WT. Preoperative prolapse stage as predictor of failure of sac-
rocolpopexy. Female Pelvic Med Reconstr Surg 2016;22:156–
60.
20. Shepherd JP, Higdon HL III, Stanford EJ, Mattox TF. Effect of
suture selection on the rate of suture or mesh erosion and sur-
gery failure in abdominal sacrocolpopexy. Female Pelvic Med
Reconstr Surg 2010;16:229–33.
21. Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS,
Lowenstein L, et al. Outcomes of abdominal and minimally
invasive sacrocolpopexy: a retrospective cohort study. Female
Pelvic Med Reconstr Surg 2014;20:33–7.
22. Kenton K, Mueller ER, Tarney C, Bresee C, Anger JT. One-
year outcomes after minimally invasive sacrocolpopexy.
Female Pelvic Med Reconstr Surg 2016;22:382–4.
23. Matthews CA, Carroll A, Hill A, Ramakrishnan V, Gill EJ.
Prospective evaluation of surgical outcomes of robot-assisted
 sacrocolpopexy and sacrocervicopexy for the management of
apical pelvic support defects. South Med J 2012;105:274–8.
24. Hill AJ, Carroll AW, Matthews CA. Unanticipated uterine
pathologic finding after morcellation during robotic-assisted
supracervical hysterectomy and cervicosacropexy for uterine
prolapse. Female Pelvic Med Reconstr Surg 2014;20:113–15.
25. Myers EM, Siff L, Osmundsen B, Geller E, Matthews CA.
Differences in recurrent prolapse at 1 year after total vs supra-
cervical hysterectomy and robotic sacrocolpopexy. Int Urogy-
necol J 2015;26:585–9.
26. Culligan PJ, Gurshumov E, Lewis C, Priestley JL, Komar J,
Shah N, et al. Subjective and objective results 1 year after
robotic sacrocolpopexy using a lightweight Y-mesh. Int Urogy-
necol J 2014;25:731–5.
27. Askew AL, Visco AG, Weidner AC, Truong T, Siddiqui NY,
Bradley MS. Does mesh weight affect time to failure
after robotic-assisted laparoscopic sacrocolpopexy? Female
Pelvic Med Reconstr Surg 2018 Oct 12 [Epub ahead of
print].
Authors’ Data Sharing Statement
Will individual participant data be available (including
data dictionaries)? No.
What data in particular will be shared? Not available.
What other documents will be available? Not available.
When will data be available (start and end dates)? Not
applicable.
By what access criteria will data be shared (including
with whom, for what types of analyses, and by what
mechanism)? Not applicable.
PEER REVIEW HISTORY
Received January 22, 2020. Received in revised form March 2,
2020. Accepted March 12, 2020. Peer reviews and author corre-
spondence are available at http://links.lww.com/AOG/B881.

364 Matthews et al Suture Type for Vaginal Graft Attachment During Sacrocolpopexy OBSTETRICS & GYNECOLOGY

© 2020 by the American College of Obstetricians

and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.