Original article by Menahem Neuman (*) - Yuval Lavy (**)
(*) Urogynecology, Dept. of Gynecology: “Shaare Zedek”, Ben-Gurion University of the Negev, “Hadassah-Har-Hazofim” and “Assuta” Medical Centers, “Leumit Advanced Personal Healthcare” and “Meuhedet Health Fund”
(**) The Hebrew University of Jerusalem, Women Health Centers of “Clalit Medical Services”
in Posterior Intra-Vaginal Slingplasty (PIVS) for vaginal apex suspension.
Objectives. Urogynecologists are
constantly looking for simple, safe and effective ways to cure vaginal
apex supportive defects. A novel surgical technique, Posterior
Intra-vaginal Slingplasty (PIVS), was described recently to concomitantly
achieve a high therapeutic efficiency with a low complication rate. Mesh
exposure was reported to complicate up to 16% of the operations. This
study evaluates surgical steps aimed to mesh exposure reduction in
PIVS-operated patients. Study design. A total of 140 patients with vaginal
apex prolapse were subjected to the PIVS operation in a daycare set-up by
one of two surgeons: In the first surgeon’s patients group (N=66) the
surgical vaginal incisions were made as small as feasible, the para-rectal
dissection was performed at the infra-fascial level, and the mucosal edges
were not trimmed. These surgical procedures, assumed to have some
anti-mesh exposure value, were not performed in the second group of
patients (N=74), who were operated by a different surgeon. Preoperative
demographics, operative details and postoperative follow-up data were
prospectively collected for all patients. Results. The demographics in
both PIVS patient’s groups were similar. A statistically non-significant
improvement regarding the mesh exposure rate was observed in the patient’s
group where the three anti-mesh-exposure surgical steps had been applied.
Conclusions. Reduction of vaginal mesh exposure rate following PIVS might
be achieved by performing three simple anti-exposure surgical steps.
However, more and long-term data is required for being able to draw solid
conclusions concerning the superiority of the discussed operative
techniques. Key words: Mesh exposure, Vaginal apical defect, Posterior
Pelvic organ prolapse is very common, and to some degree normal,
especially among older women. Yet, up to 30% of all females suffer
from pelvic floor relaxation advanced to a level, which has a
negative impact upon their quality of life. 1 The
affected women frequently require manual assistance to urinate and
to defecate, and report urinary and fecal frequency, urgency and
urge incontinence, as well as sex function-related symptoms.
The lifetime risk to undergo prolapse surgery is one in
eleven, and up to 30% of those who underwent surgery will have
repeat prolapse surgery. 5-8
There are two primary routes of access in reconstructive pelvic
surgery: the abdominal (either by laparotomy or laparoscopy)
9-10 and the vaginal approach. 11-12
Vaginal sacrospinal fixation and abdominal sacrocolpopexy have
remained the “gold-standard” for repair of vaginal apical suspension
defects. Yet, being less invasive, the vaginal approach offers a
safer option for the anatomical correction of this suspension
Though the best approach for
restoration of vaginal apical support among the commonly utilized
abdominal and vaginal routes remains controversial, the uterosacral
ligament vault suspension is the most anatomical among the repairs.
Hence, it is most unlikely that the uterosacral ligament support for
the vaginal apical prolapse will create a predisposition to future
anterior or posterior vaginal vault defects or compromise vaginal
Given that vaginal vault herniation is the result of separation of
the pubocervical fascia from the recto-vaginal and paracolpion
fascia, resulting in an apical enterocele, it should be corrected by
meticulous herniorraphy including reattachment of the vaginal vault
to the uterosacral ligaments. 23
These considerations encouraged Petros
to design an innovative procedure for the correction of the apical
vaginal support defect, through replacement of the uterovaginal
ligament encoding with a synthetic sling, positioned at the levator
plate level space via vaginal approach to the pararectal area,
performed in a daycare setting. 23-25
Mesh exposure has been described to complicate the
postoperative course of these and similar procedures in up to 16% of
the patients, necessitating additional operations. 26-29
The current study was conducted to evaluate the feasibility of
reducing the vaginal mesh exposure rate by three simple surgical
procedures: infra-fascial dissection, minimization of incisions and
non-trimming of the vaginal incision edges. These procedural steps
are intended at precluding mucosal mal-healing and hence to prevent
vaginal mesh exposure.
MATERIALS AND METHODS
Patients suffering from an advanced
vaginal apical supportive defect, diagnosed clinically according to
the International Continence Society (ICS) Pelvic Organ Prolapse
Quantification (POPQ) standard scoring system, were referred for a
PIVS (Tyco healthcare) operation. Between 1/2003 and 6/2005, 140
PIVS procedures were performed according to Petros by two surgeons
in daycare set-ups, after an informed consent form had been signed.
All patients were given one gram Monocef (Cefonicid, Beecham
Healthcare) intravenously, one hour prior to surgery. Prior to the
commencement of surgery, all patients were subjected to prophylactic
antiseptic iodine vaginal wash. The mode of anesthesia depended upon
the patient’s request. Patients presenting with additional
significant features of pelvic floor relaxation had anterior and
posterior colporrhaphy, concomitant with the apical supportive
surgery. Patients with uterine prolapse were asked to elect either
vaginal hysterectomy or preservation of the uterus, while the
uterine cervix was amputated if it dilated over more than half of
the vaginal length. 30
The first patient’s (study) group was subjected to three
anti-mesh-exposure surgical procedures: 1) The initial incision at
the posterior vaginal wall was minimized, ending more than 2 cm from
the tape anchoring point at the vaginal apex. 2) The
medial-to-lateral dissection developing the para-rectal space was
made under the fascia rather then the traditional supra-fascial
method of dissection. 3) The vaginal wall free edges were not
trimmed prior to incision closure as usually is done with
These 3 additional surgical procedures were not performed in the
second (control) group of patients. Intra-operative and
post-operative complications were prospectively recorded. The
patients were interviewed in the first and sixth postoperative month
and yearly thereafter, with 6 to 24 months follow-up. Subjective
data was prospectively recorded regarding urinal and fecal urgency,
frequency, stress and urge incontinence, sexual function
impairments, voiding habits and pelvic pain and bulging.
Objective findings, including verification of urine and feces
leakage, relaxation and prolapse of pelvic floor and organs, were
also prospectively collected through a physical pelvic examination
according to the ICS standards terminology. All statistical analyses
were performed with SPSS 10.1.4 (SPSS Inc, Chicago, IL). Student’s T
test was used for the quantitative variants analysis, while Fisher’s
exact test and the Chi-square test were applied for the categorical
variants. All statistical tests were evaluated at the 0.05
One hundred and forty patients diagnosed
with vaginal vault prolapse stage 3 or 4 according to the POPQ
standard scoring system (D point 1 cm or more beyond the hymeneal
ring) were enrolled into this study. All demographic and personal
details are tabulated in
Fifty-eight (41.4%) patients were 0.5 to 25 years post hysterectomy
(26 by abdominal and 32 by vaginal approach), 10 (7.1%) had
undergone previous pelvic floor reconstructive surgery and 7 (5.0%)
had undergone previous anti-incontinence surgery. One hundred
thirty-seven (97.9%) of the patients presenting with significant
features of pelvic floor relaxation underwent successful anterior
and posterior colporrhaphy.
Forty-four (31.4%) among those underwent vaginal hysterectomy and
nine (6.4%) underwent cervical amputation concomitantly with PIVS.
Thirty-five (25.0%) underwent anti-incontinence surgery (either TVT
or TVT-Obturator) in addition to PIVS (Table
The only statistically significant difference in pre-operative
details between the study and control patients groups found related
to bladder over-activity, 30% versus 94%, respectively.
The patients were operated on by one of two surgeons: one performed
the three anti-mesh-exposure surgical steps in the study group
(N=66); these were omitted by the second surgeon who operated on the
control group (N=74). When comparing the study and control patient
groups, no significant differences regarding operative details or
intra-operative complications were recorded with the exception of
the mode of anesthesia, general or regional: 78% and 22%
respectively for the study group, compared to 28% and 72%
respectively for the control group.
Two study group patients and four control group patients suffered
early post-operative hematoma within the para-rectal fossa. These
patients were treated orally with prophylactic broad-spectrum
antibiotics and recovered spontaneously without need for infusion of
blood products or bleeding control procedures.
Three (2.1%) patients, two of the
study group and one of the control group, presented with operative
failure, as the D point was found to be over 1 cm beyond the
hymeneal ring. Four patients (2.9%) had a significant postoperative
vaginal wall defect: three (of the control group) had cystocele and
one (of the study group) had rectocele beyond the hymeneal ring,
necessitating further corrective procedures. According to the POPQ
measurements of the post-operative procedures, the cystocele,
rectocele and vaginal vault prolapse corrections were satisfying in
93.9% of the study group patients and 95.9% of the control group
One patient of the control group, who developed post-operative
unilateral gluteal skin infection, was treated by surgical removal
of the affected hemi-tape; the vaginal apex remained well suspended.
Thirteen patients, four of the study group and nine of the control
group, had vaginal mesh exposure. Ten of these patients underwent
segmental tape resection at the outpatient clinic and three remained
without treatment. Two patients (1.4%), one of each patient group,
had complete spontaneous tape expulsion while the vaginal apex
remained well suspended. One control group patient suffered
post-operative fever of unknown origin, which recovered with oral
antibiotics. All patients desiring sexual intercourse were able to
do so, dyspareunia was not reported, and no de-novo post-operative
urinary incontinence was recorded.
Pelvic organ prolapse (POP) may occur in up to 50% of parous women.
It may cause a variety of urinary, bowel and sexual symptoms,
1-4 and is reported to necessitate surgical correction in 11%
of the female population.4 Previous hysterectomy, vaginal
rather than abdominal, aggravates the risk for further vaginal
prolapse. This probably is due to surgical damage as well as to
pre-existing weakness of the pelvic floor. 7
Neither simple colporrhaphy, with or without plication of the
uterosacral ligaments, nor sacrospinous and sacral colpopexies, seem
to be the preferred procedures for repairing vaginal prolapse. Some
authors observed that these procedures are associated with an up to
58% recurrence rate in terms of objective POPQ scoring and prolapse
related subjective symptoms, 6 while others reported a
recurrent surgery rate for pelvic floor reconstruction of 30%.
The use of mesh for fixing the vaginal apex to achieve sacral
anchorage frequently resulted in vaginal mesh erosion and
protrusion, complicating colposacral fixation.
Sacro-spinous colpopexy, thought to be
less invasive and safer than the abdominal route,11 was
reported to be complicated by post-operative dyspareunia, buttock
pain, urinary and fecal incontinence, cystocele and rectocele
formation, 17 altered defecation and constipation,
bladder injuries, urinary retention and infections. 14
Laparoscopic sacral colpopexy necessitates meticulous and
proper prior training 9-10 and, therefore, was unpopular.
Against this background, Petros was encouraged to develop the novel
PIVS, entailing minimal invasiveness via a vaginal approach together
with anatomical restoration of the uterosacral ligament suspension
of the vaginal apex, performed in a daycare set-up. 24-26
Magnetic resonance imaging showed that significant improvements in
the restoration of the vaginal configuration were achieved in
patients who underwent PIVS.21 The operative results in
the current series of patients are in agreement with previously
reported data regarding the safety and efficacy of the PIVS method
for vaginal apex support.24-26
The PIVS operation facilitates uterine conservation, even in the
event of advanced uterine prolapse. The restoration of the
uterosacral ligaments support enables the surgeon to re-suspend the
uterine isthmus, hereby avoiding the necessity to perform vaginal
hysterectomy for the treatment of uterine prolapse. In the current
series of patients, the restoration of the uterosacral ligaments
support along with uterine preservation was performed in 38 (27.1%)
of the women according to their personal preferences. One of the
repeatedly reported PIVS complications is post-operative vaginal
mesh exposure. 29-33
This study was aimed at evaluating the introduction of three
preventative surgical measures, namely infra-fascial undermining,
minimization of the incision and non-trimming. The study and control
group showed statistically significant differences regarding
preoperative bladder over-activity (30% versus 94% respectively) and
regarding the mode of anesthesia, being general or regional: 78% and
22% respectively in the study group versus 28% and 72% respectively
in the control group.
According to the POPQ measurements on the post-operative patients,
the cystocele, rectocele and vaginal vault prolapse corrections were
satisfactory in 133 (95%) of the patients, 93.9% in the study group
and 95.9% in the control group. Bladder over-activity symptoms,
preoperatively troublesome for 30% of the study group patients and
for 94% of the control group patients were reduced post-operatively
to 6.0% and 6.7% respectively. An explanation for this finding was
offered earlier by Petros, suggesting that the well supported
bladder tends to fire less neurological electrical activity than the
poorly supported one. 26
The two patients groups are similar, except for the bladder
over-activity and the mode of anesthesia. Those differences should
not bias the study conclusions regarding the value of the three
preventive steps to avoid tape protrusion, performed with the study
group patients, but not with those in the control group. This
included minimization of the incision at the posterior vaginal wall,
making the para-rectal space dissection below the fascial level
rather than the traditional supra-fascial method and not trimming
the vaginal wall free edges.
These steps, which seemingly improve mesh covering and mucosal
healing, and might bring about some reduction of the tape exposure
rate, do not seem to interfere with the well-proven efficacy and
safety of the PIVS operation. The fact that the difference between
the study and control group exposure rates (6.0% and 12.2%
respectively) was not statistically significant might be attributed
to the rather relatively small patient groups. It was
retrospectively calculated that, for the above-reported exposure
percentages, a sample size of 280 women per group would be required
to prove a significant difference in mesh exposure rate between the
two patient groups at a power of 80% (alpha=5%).
Implementation of the above
mentioned anti-exposure surgical procedures might ameliorate the
patient’s satisfaction and reduce the need for reparations after
PIVS. This should be proved by additional studies before being
adopted as proven preventive measures for vaginally implanted mesh
Three simple surgical steps, which are
safe, effective and easy-to-perform procedures, might reduce mesh
exposure after Posterior Intravaginal Slingplasty. If supported by
additional and long-term data, this might be adopted for other
vaginal mesh implants to cure pelvic floor supportive defects, to
avoid one of the rather frequent complications of these operations.
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