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Geller 2021
Geller 2021
Geller 2021
ABSTRACT Study Objective: To evaluate sexual function in women undergoing minimally invasive total hysterectomy and sacrocolpo-
pexy (TLH + SCP) with a lightweight polypropylene Y-mesh 1 year after surgery.
Design: This was a planned secondary analysis of a 5-site randomized trial comparing permanent (2-0 Gore-Tex; W. L.
Gore & Associates, Inc., Newark, DE) vs absorbable suture (2-0 polydioxanone suture) for vaginal attachment of a Y-mesh
(Upsylon; Boston Scientific Corporation, Natick, MA) graft during TLH + SCP.
Setting: Multicenter trial at 5 study sites (4 academic and 1 community). The study sites were: (1) University of North Caro-
lina at Chapel Hill, Chapel Hill, NC; (2) Wake Forest Baptist Hospital, Winston-Salem, NC; (3) Northwestern University,
Evanston, IL; (4) Georgia Regents University, Augusta, GA; and (5) Atlantic Health Medical Group, Morristown, NJ.
Patients: Women previously enrolled in an original study undergoing TLH + SCP.
Interventions: Quality-of-life questionnaires and physical examination.
Measurements and Main Results: The primary objective was to assess changes in sexual function at 1 year after surgery
as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological
Association−Revised. The secondary objective was to assess the factors associated with postoperative sexual activity and
dyspareunia. Of the 200 participants enrolled, 182 (92.8%) completed follow-up: n = 95/99 Gore-Tex and n = 87/101 poly-
dioxanone suture. The mean age was 60 § 10 years; body mass index was 27 § 5 kg/m2; 78% were menopausal and 56%
sexually active before surgery. At 1 year after surgery, 63% were sexually active: 93% of the sexually active women preop-
eratively remained so at 1 year, and 24% reported new sexual activity at 1 year (p <.001). Sexual function at 1 year showed
marked improvement in activity, quality, and arousal/orgasm compared with baseline Pelvic Organ Prolapse/Urinary Incon-
tinence Sexual Questionnaire scores. Dyspareunia rates decreased from 22% preoperatively to 16.5% at 1 year (p = .65).
Women who were sexually active at 1 year were younger (56.8 § 9.6 years vs 65.4 § 9.2 years, p <.001), more likely to be
premenopausal (31.6% vs 7.4%, p = .001), and less likely to undergo bilateral salpingo-oophorectomy (53.3% vs 78.9%,
p <.001).
Conclusion: Women undergoing TLH + SCP with a lightweight mesh graft report increased rates of sexual activity,
improved sexual quality and arousal/orgasm, and lower rates of dyspareunia at 1 year after surgery. Journal of Minimally
Invasive Gynecology (2021) 00, 1−7. © 2021 AAGL. All rights reserved.
Keywords: Prolapse; Dyspareunia; Mesh
Catherine A. Matthews and Kim Kenton are consultants for Boston Scien- Corresponding author: Elizabeth J. Geller, MD, Department of Obstetrics
tific Corporation and expert witnesses for defense for Johnson & Johnson. and Gynecology, University of California, CB 7570, Old Clinic, Chapel
This work was supported by an unrestricted research grant from Boston Hill, NC 27599-7570.
Scientific Corporation. The other authors declare that they have no conflict E-mail: egeller@med.unc.edu
of interest.
This work was presented at the American Urogynecology Society Annual Submitted November 18, 2020, Revised January 15, 2021, Accepted for pub-
Scientific Meeting, October XX, 2020. lication January 23, 2021.
Available at www.sciencedirect.com and www.jmig.org
Sexual function is an important component of quality of absorbable 2-0 PDS suture took place in the operating room
life and can be affected by pelvic organ prolapse (POP) and before mesh graft attachment. The participants and research
the resultant surgical interventions [1]. In a study evaluating staff were blinded to the treatment assignment, and blinding
patient perceptions of adverse outcomes after surgery, was maintained through the 1-year follow-up visit.
women rated a lack of improvement in sexual function after Baseline demographic information was collected,
surgery as akin to chronic pain or an intensive care unit including past medical and surgical history and medica-
admission [2]. Because the estimated lifetime risk of under- tions, and a physical examination, including pelvic exami-
going surgery for prolapse or incontinence is 11% to 19% nation and POP quantification (POP-Q) examination, was
[3] and because the rate of pelvic floor disorders continues performed. The participants completed the Pelvic Organ
to rise, the need for durable surgical repairs without an Prolapse/Incontinence Sexual Questionnaire, International
adverse impact on sexual function has become critical. Urogynecological Association−Revised (PISQ-IR) [13].
Abdominal sacrocolpopexy (SCP) is considered to be the The PISQ-IR is a validated tool that was developed by an
most durable operation for advanced POP [4−6] and is International Urogynecological Association panel of
offered as a primary surgical option for uterovaginal pro- experts to enhance the original PISQ, specifically the ability
lapse to improve longer-term surgical outcomes [7]. to also assess sexual function outcomes in women who are
Although SCP has been associated with lower rates of dys- not sexually active with a partner. Sexual activity was based
pareunia than native tissue vaginal repair of vaginal vault on the response to question 1 on the PISQ-IR, which asks
prolapse [8], sexual outcomes after SCP with concomitant whether the respondent is sexually active or not. Dyspareu-
total hysterectomy (TLH) are unknown. Higher rates of nia was directly assessed with question 11 on the PISQ-IR,
mesh exposure related to performance of colpotomy may which asks, “How often do you feel pain during sexual
influence the incidence of dyspareunia and sexual dysfunc- intercourse?” A response of “Sometimes” or higher
tion [9]. United States Food and Drug Administration (“Usually,” “Always”) was considered positive.
actions relating to mesh prolapse repairs have heightened All participants underwent TLH with or without bilat-
awareness and concerns over prolapse repair and risks of eral salpingo-oophorectomy (BSO) (at the discretion of
adverse outcomes such as dyspareunia [10]. the patient and surgeon) before laparoscopic SCP, with
A systematic review by the Society of Gynecologic Sur- or without robotic assistance. All hysterectomies were
geons of mesh-specific complications for transvaginal mesh performed for the indication of prolapse. Surgeon prefer-
criticized the lack of validated measures in most studies, ence determined the method of vaginal cuff closure and
which typically only reported pain, to assess global sexual included interrupted vs continuous sutures using barbed,
function [11]. Although mesh complication rates are lower monofilament, or braided absorbable suture material.
with transabdominal pelvic mesh compared with transvagi- Upsylon mesh was used for SCP. Upsylon is a pre-
nal mesh, the same standards for comprehensive reporting formed type I polypropylene Y-mesh that is lightweight
of patient-centered outcomes such as sexual function are (25 g/m2), with a pore size of 2.8 mm2 and surface area
needed. ratio of 1.11. Optional additional procedures included
It is not fully understood what impact minimally inva- any full-length midurethral sling for treatment or pre-
sive TLH + SCP may have on sexual function. This infor- vention of stress incontinence that was placed through a
mation is necessary for preoperative surgical counseling. separate vaginal incision, retropubic urethropexy, and
Therefore, our primary objective of this secondary analysis distal posterior colporrhaphy per surgeon discretion. All
was to assess changes in sexual function from baseline to 1 intraoperative study variables, including intraoperative
year after minimally invasive SCP. Our secondary objective complications, were recorded in real time. Postoperative
was to assess the clinical factors associated with sexual complications were categorized using the Clavien-Dindo
function at 1 year after surgery, including sexual activity, surgical complication grading scale [14].
sexual quality, and dyspareunia. Sexual function as well as symptomatic and anatomic
improvement of POP were evaluated at 6 weeks and 1 year
after surgery with the PISQ-IR, pelvic examination, and
Materials and Methods
POP-Q. A blinded examiner completed the pelvic examina-
This was a planned secondary analysis of a 5-site random- tion and POP-Q. Any SCP mesh that was visible in the
ized trial comparing permanent (2-0 Gore-Tex; W. L. Gore vagina was reported as a mesh exposure. Permanent suture
& Associates, Inc., Newark, DE) vs absorbable suture (2-0 material that was visible in the vagina beyond 12 weeks
polydioxanone suture [PDS]) for vaginal attachment of a Y- was reported as a suture exposure.
mesh (Upsylon; Boston Scientific Corporation, Natick, MA) Means and standard deviations or counts and percen-
graft during TLH + SCP. The original study took place tages were computed for univariate analyses using continu-
between April 2015 and May 2019, and the methodology of ous and categorical data, respectively. The t test, chi-square
the primary study was previously published [12]. Institutional test, or Fisher exact test were used for bivariate analyses. A
review board approval was obtained at each clinical site. p-value ≤.05 was considered statistically significant. All
Randomization to permanent 2-0 Gore-Tex vs delayed- analyses were performed using version 27 IBM SPSS
Geller et al. Sexual Function after Minimally Invasive TLH and SCP 3
(Armonk, NY). The primary objective was to assess IQR −3 to 3). There were also no differences in surgical
changes in sexual function at 1 year after surgery. The sec- characteristics and concomitant procedures between the
ondary objective was to assess the factors associated with groups. Overall, 75.5% of the cases were performed with
the quality of sexual activity and changes in dyspareunia at robotic assistance, with no differences in concomitant pro-
1 year after surgery. cedures, surgical times, learner involvement, estimated
blood loss, length of stay, postoperative retention, or com-
plications between the Gore-Tex and PDS groups.
Results
Our primary outcome was change in sexual function at 1
Of the 200 participants enrolled in the original study, year after surgery. We found that, at baseline, 56% of the
182 (92.8%) completed 1 year follow-up (n = 95/99 Gore- women were sexually active, with no differences between
Tex, n = 87/101 PDS). There were no baseline differences the Gore-Tex and PDS groups. At 1 year after surgery, the
between the 2 groups (Table 1). The mean age was 60 § rate of sexually active women increased to 63%, with no
10 years, and most were Caucasian, overweight, postmeno- difference between the suture groups (p = .09). Of the
pausal, nonsmokers, privately insured, with low morbidity, women who were sexually active at baseline, 93%
and not likely to have had prior prolapse or incontinence remained sexually active at 1 year. Of those who were not
surgery. Median preoperative POP-Q showed stage III ante- sexually active at baseline, 24% were sexually active at 1
rior prolapse (Ba 2, IQR 0.9−4), stage II posterior prolapse year (p <.001). The incidence of de novo dyspareunia was
(Bp −1, IQR −2 to 0.1), and stage II apical prolapse (C 0, 8.2%.
Table 1
Baseline demographics
BMI = body mass index; IQR = interquartile range; POP-Q = pelvic organ prolapse quantification; SD = standard deviation.
Data are presented as n § SD or number (%).
* Fisher exact test (otherwise t test or chi-square test).
4 Journal of Minimally Invasive Gynecology. Vol 00, No 00, 00 2021
Table 2
Characteristics associated with sexual activity 1 year after surgery
BSO = bilateral salpingo-oophorectomy; PDS = polydioxanone suture; POP-Q = pelvic organ prolapse quantification; SCP = sacrocolpopexy; SD = standard deviation.
Data are presented as n § SD or number (%).
* Fisher exact test (otherwise t test or chi-square test).
Our secondary outcomes included the factors associated and those who were not at 1 year after surgery. There was a
with sexual function and dyspareunia at 1 year after surgery difference seen in vaginal cuff suture type and technique.
(Table 2). We found that the women who were sexually The women who were sexually active at 1 year after surgery
active 1 year after surgery were younger (56.8 § 9.6 years were more likely to have a barbed, continuous suture for
vs 65.4 § 9.2 years, p <.001), more likely to be premeno- cuff closure. Sexual activity at 1 year postoperatively was
pausal (31.6% vs 7.4%, p = .001), more likely to be sexually not associated with robotic route, concomitant anterior or
active before surgery, and less likely to undergo BSO posterior repair, perineorrhaphy, or mesh sling. Mesh or
(53.3% vs 78.9%, p <.001). There were no differences in suture exposure was also not associated with sexual activity
race, smoking status, baseline dyspareunia, or baseline gen- or dyspareunia. In addition, there was no difference in 1
eralized pain between the women who were sexually active year POP-Q stage between women who were sexually
Geller et al. Sexual Function after Minimally Invasive TLH and SCP 5
Table 3
Sexual function on the basis of PISQ-IR scores before and 1 year after surgery
PISQ domain scores Sexually active at baseline Sexually active at 1 year after surgery p-value
active and those who were not, with most of the women at Discussion
stage 0 or I in both groups. There was no difference in base-
line or 1-year total vaginal length between those who were Women undergoing minimally invasive TLH + SCP with a
sexually active and those who were not at 1 year. lightweight Y-mesh material reported significant improvement
We also assessed sexual function and quality of sexual in sexual function at 1 year after surgery, with increased rates
activity using responses to the PISQ-IR. Among the women of sexual activity, improved sexual quality and arousal/orgasm,
who were sexually active, sexual function showed a marked and lower rates of dyspareunia compared with before surgery.
improvement in both sexual activity and sexual quality at 1 Despite mesh exposure reported in 6% of the overall cohort
year after surgery compared with baseline (Table 3). The [12], there was no association between mesh exposure and any
areas of improvement in sexual function included the sexual function parameter.
impact of prolapse on sexual activity, the impact of pro- Certain characteristics, including younger age, pre-
lapse on sexual quality, the global rating of sexual quality, menopausal status, and baseline sexual activity, were
and sexual arousal/orgasm. There were no differences seen associated with being sexually active at 1 year after mini-
in sexual desire or partner-related impact (PR) compared mally invasive TLH + SCP. We may be reassured by the
with baseline. For non−sexually active women, there were fact that neither baseline generalized pain nor concomi-
also improvements in sexual function on the basis of the tant mesh sling were associated with dyspareunia at 1
PISQ-IR scores at 1 year after surgery compared with base- year after surgery because these are reported risk factors
line, including the impact of prolapse on sexual activity, for transvaginally placed mesh [15]. In addition, there
impact of prolapse on sexual quality, global rating of sexual was no difference in sexual desire or PR, which is helpful
quality, and PR scores (all p <.05). because it shows that women continue to have sexual
Among the women who were sexually active at 1 year after desire even if they are not sexually active and that PR is
surgery, the rates of dyspareunia decreased from 22% preoper- not affected by this surgery.
atively to 15% at 1 year (p = .65), with no difference between Surgical correction of POP seems to have a positive
the Gore-Tex and PDS groups (Table 4). In bivariate analyses, impact on sexual activity and dyspareunia, regardless of
dyspareunia at 1 year was associated with laparoscopic route surgical technique. The Pelvic Floor Disorders Network
compared with robotic route; interrupted vaginal cuff closure recently published a secondary analysis of 4 trials of dif-
technique compared with continuous; and vaginal cuff suture ferent methods of POP repair to assess sexual activity
closure material: “other” suture types had increased risk com- and dyspareunia, 1 of which was the Colpopexy and Uri-
pared with barbed suture, polyglactin, and polydioxanone. nary Reduction Efforts trial that included women under-
However, in a regression model, route of surgery and cuff going abdominal SCP [1]. Overall, dyspareunia resolved
suture type and technique did not remain significantly associ- in 3 out of 4 women, with no difference between women
ated with dyspareunia. Dyspareunia at 1 year was not associ- who had native tissue vs mesh-augmented repairs. Simi-
ated with race, smoking status, menopausal status, pre- or larly, Rogers et al [16] assessed sexual function after
postoperative POP-Q or total vaginal length, preoperative sex- surgery for stress urinary incontinence and/or POP using
ual activity, preoperative dyspareunia, preoperative generalized a variety of surgical interventions as a secondary analy-
pain, concomitant procedures for POP or urinary incontinence, sis. At 3 to 6 months after surgery, they report findings
or mesh/permanent suture exposure. In terms of sexual func- similar to ours, specifically improved sexual function on
tion, dyspareunia at 1 year was inversely associated with sexual the basis of the PISQ scores. However, the study popula-
arousal/orgasm on the PISQ-IR (p <.001), indicating less sex- tion was a heterogenous surgical group, including hyster-
ual arousal/orgasm in women who reported dyspareunia. ectomy, various types of prolapse repair, incontinence
6 Journal of Minimally Invasive Gynecology. Vol 00, No 00, 00 2021
Table 4
Characteristics associated with dyspareunia 1 year after surgery
BSO = bilateral salpingo-oophorectomy; PDS = polydioxanone suture; POP-Q = pelvic organ prolapse quantification; SCP = sacrocolpopexy; SD = standard deviation.
Analysis only includes sexually active women because dyspareunia only applies to this group.
Data are presented as n § SD or number (%).
* Fisher exact test (otherwise t test or chi-square test).
repair and/or BSO. Handa et al [17] reported sexual Similarly, they found no difference in sexual desire after
function 1 year after abdominal SCP and Burch urethro- surgery.
pexy as a secondary analysis of the Colpopexy and Uri- Two smaller, noncomparative trials of abdominal and
nary Reduction Efforts trial. Using the PISQ robot-assisted SCP have provided information about specific
questionnaire, they found results similar to ours; specifi- components of sexual function. Kuhn et al [18] reported an
cally an increase in sexual activity and a decrease in improvement in sexual desire, arousal, lubrication, satisfac-
dyspareunia. There was no difference in dyspareunia on tion, and pain at 2 years after surgery compared with baseline.
the basis of concomitant Burch colposuspension, which They found no difference in orgasm. Similarly, Geller et al
is similar to our finding for vaginal mesh sling. [19] noted an improvement 3 months after robotic SCP on the
Geller et al. Sexual Function after Minimally Invasive TLH and SCP 7