# Outcome of Treatment of Anterior Vaginal Wall Prolapse and Stress Urinary Incontinence with Transobturator Tension-Free Vaginal Mesh (Prolift) and Concomitant Tension-Free Vaginal Tape-Obturator

Authors: Ashraf Abou-Elela; Essam Salah; Haitham Torky; Sameh Azazy
Journal: Advances in Urology
 (2009)

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## Abstract

Objective. It is to assess the feasibility, effectiveness, and safety of transobturator tension-free vaginal mesh (Prolift) and concomitant tension-free vaginal tape-obturator (TVT-O) system as a treatment of female anterior vaginal wall prolapse associated with stress urinary incontinence (SUI). Patients and Methods. Between December 2006 and July 2007, 20 patients with anterior genital prolapse and voiding dysfunction were treated with the transobturator tension-free vaginal mesh (Prolift) and concomitant tension-free vaginal tape-obturator (TVT-O). Sixteen patients had stress urinary incontinence and 4 patients were considered at risk for development of de novo stress incontinence after the prolapse is repaired. All patients underwent a complete urodynamic assessment. All the patients underwent pelvic examination 4–6 weeks after the operation, and anatomical and functional outcomes were recorded. Results. Twenty cystocoeles were repaired: 6 grade II, 12 grade III, and 2 grade IV. There were no vessel or bladder injuries. Eighteen patients had optimal anatomic results and 2 patients had persistent asymptomatic stage I prolapse. Conclusion. These preliminary results suggest that Prolift system offers a safe and effective treatment for female anterior vaginal wall prolapse. However, a long-term followup is necessary in order to support the good result maintenance.


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## Body

## 1. Introduction

Genital prolapse affects the quality of life of women [1]. More than 50% of multiparas suffer this problem [2]. The estimated
lifetime risk of surgery for prolapse or incontinence is 11%, with one of three
patients requiring more than one surgical repair [3]. Pathogenesis of
genital prolapse is the result of the weakness of any or all of the pelvic
support structures, that is, levator ani muscle, connective tissue, uterosacral
and cardinal ligaments, and rectovaginal fascia [4]. Anterior vaginal
wall prolapse may coexist with disorders of micturition. Mild anterior vaginal
wall prolapse usually presents few problems. As prolapse progresses, symptoms
may develop and worsen, and treatment becomes indicated. The classic surgical
techniques have a high recurrence rate that could be between 5 and 40% for
cystocel [5, 6]. Considering pelvic organ prolapse as a hernia through
the genital hiatus, nonabsorbable mesh has been advocated for high-grade genital
prolapse, based on its use in general surgery for hernia repair [7]. The perfect mesh must be biocompatible, inert, sterile, not carcinogenous,
not allergenic, and resistant. Currently, polypropylene macrospore monofilament
gynecological mesh has been used as fascial strengthening, with tension-free technique,
reducing the possibility of relapse. A new mesh system for treatment of genital
prolapse is the system Prolift [8]. It is a wide mesh with an anchor
system that provides a complete support and is applied with a minimal invasive technique.
We used the new system Prolift with the objective of reviewing the safety and
effectiveness for the treatment of female anterior vaginal wall prolapse.


## 2. Patients and Methods

Between December 2006 and July 2007, twenty patients affected with
anterior prolapse were included in this prospective survey. All the patients
were referred to our Urology Unit because of their voiding problems. Mean age
was 52 years (36–76). Mean parity,
3 vaginal childbirths. Sixteen patients with anterior vaginal wall prolapse
reported
socially annoying type II or III urinary stress incontinence, 4 patients
reported voiding difficulty and related a history of urinary incontinence that
has resolved with worsening of their prolapse. These patients were considered
at risk for development of de novo stress incontinence after the prolapse is
repaired. Twelve patients reported symptoms
related to prolapse including the sensation of a vaginal mass
or bulge, pelvic pressure, low back pain, and sexual difficulty. Twelve
patients were sexually active, 8 had sexual difficulty (Table1). The examination was
first performed with the patient supine in lithotomy position. A retractor or
Sims speculum was used to depress the posterior vagina to aid in visualizing
the anterior vagina. After the resting examination, the patient was instructed
to strain down forcefully or to cough vigorously. During this maneuver, the order of descent of the pelvic organs and their relationship at the peak of straining were noted. If physical findings did not correspond to symptoms or if the
maximum extent of the prolapse could not be confirmed, the woman was reexamined
in the standing position.Table 1
Demographic and clinical
characteristics of the patients.
CharacteristicsPatientsMedian age (y) (range)52 (36–76)Median parity (range)3 (0–9)Median BMI (range)31.2 (21.4–41.5)Prior surgery for prolapse including hysterectomy (n, %)3 (15)Prior hysterectomy for benign tumor (n, %)4 (20)Stage of prolapseStage II (n, %)6 (30)Stage III (n, %)12 (60)Stage IV (n, %)2 (10)Urinary incontinence (n, %)16 (80)A urinalysis was performed to evaluate for urinary tract
infection. In all patients, whether with stress urine incontinence or voiding
dysfunction and probability to develop incontinence after the repair, a
complete urodynamic assessment was performed. In women with grade III and IV
prolapse, the urethral function was checked after the prolapse is repositioned.
Urodynamic evaluation confirmed the diagnosis of SUI in 16 patients, and in the
remaining 4 patients after repositioning of the prolapse Valsalva, leak point pressure was obtained with the
patient standing, filled to bladder capacity, and the urethral catheter
removed. It was defined as the lowest abdominal pressure occurring during the
Valsalva maneuver that resulted in leakage of fluid per urethra. Based on
preoperative urodynamics, we defined genuine stress incontinence as a Valsalva
leak point pressure of greater than 50 cm H2O.Completeness of bladder
emptying was measured with a timed void followed by bladder ultrasonography to
measure residual urine volume. In menopauses women with atrophic status, the
vaginal mucosa was prepared using local estriol 21 days before the procedure.Surgical Technique
All patients received spinal anesthesia and cephalosporin and
metronidazol as antibiotic prophylaxis. The patient is placed in the lithotomy
position and her thighs flexed approximately 90 degrees. A 16 Fr Foley catheter
is placed to empty the bladder.
The technique involves implantation of a large sheet of
high-porosity monofilament polypropylene “tension-free” mesh featuring anterior
intervesicovaginal prosthesis. The anterior prosthesis is retained by two nonsecured
bilateral transobturator arms anteriorly at a point 1 to 2 cm from the proximal
arcus tendineus fasciae pelvis and posteriorly at a point 1 to 2 cm distal from
the arcus tendineus fasciae pelvis (Figure1). Four cannulas are inserted at the fixation points
with the use of a single trocar needle; the mesh arms are retrieved with a plastic
loop and secured after implantation of the mesh and removal of the cannulas (Figure 2). In
all patients, a tension-free vaginal tape-obturator (TVT-O) procedure
was performed in all cases through a separate incision at the mid urethra after
the mesh procedure for proper positioning and to avoid displacement. The
hospital discharge was at 48 hours. All intraoperative and postoperative
complications were recorded. All the patients underwent pelvic examination 4–6 weeks after the
operation, and anatomical and functional outcomes were recorded. The patients
estimated the severity of their prolapse symptoms before and after the
operation, together with lifestyle and urinary and sexual discomfort, on a visual analog scale with a score range
of 0 to 10 (0 corresponding to no discomfort, and 10 to maximum discomfort).
Postoperative followup consisted of clinical control at 6 weeks and 6 months
assessing the results of the prolapse treatment. Also, a satisfaction
questionnaire was required.Figure 1
Bladder dissected from the anterior vaginal wall and 3 of the 4 cannulas and retrieval device in Prolift anterior mesh.Figure 2
Prolift in place after reduction of the cystocoele.


## 3. Results

Twenty cystocoeles were repaired: 6 grade II, 12 grade III, and
2 grade IV. In all patients, we carried out simultaneous procedure TVT-O for
type II and III stress incontinence.Surgical mean time for anterior Prolift and TVT-O was 45
minutes (30–55 minutes). Anterior
Prolift was 40 minutes (range 30–50). No
intraoperative complications were registered. There were no vessel or bladder
injuries. During the immediate postoperative period, a case of moderate
perivesical hematoma was registered. The patient was a 62-year-old woman
operated with anterior Prolift due to a grade II cystocoele and TVT-O. Oral
analgesic and anti-inflammatory treatment was instituted with complete
resolution. No reoperation was required.Regarding to the satisfaction grade at 6 weeks and 6 months,
all the patients answered are
to be satisfied. The
lifestyle discomfort score and the urinary discomfort score fell significantly
after surgery while the sexual discomfort score did not change significantly
after the operation in sexually active patients. One patient experienced
dyspareunia after the procedure.Eighteen patients had optimal anatomic results (Figure3) and 2 patients
had persistent asymptomatic stage I prolapse. Mean following time was 8 months
(6–14 months). No
infection or rejection of the mesh occurred during followup. With regard to the
simultaneous correction of the urine incontinence, in all the patients, it was
successful. A patient was considered cured of SUI if she reported no leakage and
satisfaction with the surgical outcome on questionnaire analysis, plus no urine
loss on provocative physical examination. No cases of urine incontinence were
observed after the procedure.(a), (b) Preoperative ascending cystogram of a patient with G III
cystocoele and severe SUI. (c), (d) Postoperative ascending cystogram of the same patient, 6 weeks after Prolift and TVT-O insertion.
(a)(b)(c)(d)


## 4. Discussion

Anterior vaginal wall prolapse occurs commonly and may coexist
with disorders of micturition. Mild anterior vaginal wall prolapse often occurs
in parous women but usually presents few problems. As prolapse progresses,
symptoms may develop and worsen, and treatment becomes indicated.Nichols and Randall [9] described two types of anterior
vaginal wall prolapse: distention and displacement. Distention was thought to
result from overstretching and attenuation of the anterior vaginal wall, caused
by overdistention of the vagina associated with vaginal delivery or atrophic
changes associated with aging and menopause. The distinguishing physical
feature of this type was described as diminished or absent rugal folds. The
other type, displacement, was attributed to pathologic detachment or elongation
of the anterolateral vaginal supports to the arcus tendineus fasciae pelvis,
resulting in descent of the anterior segment with the rugae intact.Another theory ascribes most cases of anterior vaginal wall
prolapse to disruption or detachment of the lateral connective tissue
attachments at the arcus tendineus fasciae pelvis, resulting in a paravaginal
defect and corresponding to the displacement type discussed above. This was
described by Richardson et al. in 1976 [10]. These
researchers described transverse defects, midline defects, and defects
involving isolated loss of integrity of pubourethral ligaments. Transverse defects
were said to occur when the “pubocervical” fascia separated from its insertion
around the cervix, whereas midline defects represented an anteroposterior
separation of the fascia between the bladder and vagina.More recent innovative approaches for anterior vaginal wall
repair anchor an allograft, xenograft, or polypropylene mesh without tension
via strips placed through the obturator foramen with a special device (Anterior
Prolift, Gynecare). These techniques await safety and efficacy studies but are
increasing in use. The advantage of this approach is that all defects (central,
lateral, proximal, and distal) can be treated in a time-efficient manner.Placement of nonabsorbable mesh into an anterior vaginal wall
prolapse repair is a promising but more controversial variation. Polypropylene
mesh has limited foreign body reaction in general and is probably the best
choice. Technique variations include mesh overlays, modified four-corner
attachments, transobturator attachments, and anterior flaps as part of an
apical mesh procedure. Cure rates appear high but comparative trials with more
traditional sutured repairs have not been done. The goal of the procedure is to
reestablish level II support of the vagina. In our preliminary study of
patients with stage II, III, or IV prolapse, 90% of women had an optimal
anatomic outcome, while the remaining 10% had persistent but asymptomatic
anterior vaginal wall prolapse. These results are in keeping with those of Migliari,
who reported the persistence of asymptomatic grade 1 cystocele after
tension-free vaginal mesh repair of anterior vaginal wall prolapse (grade 3 in
25% of cases) [11].In our study with a relatively short-term followup, the
subjective anterior vaginal wall prolapse cure rate was 100%. A significant
improvement in quality of life was also obtained. Ruparelia et al. reported a
patient satisfaction rate of 85% twenty months after anterior vaginal wall
repair with porcine skin collagen implants [12].Short-term patient satisfaction rates range from 74% to 100%
after vaginal wall repair with nonabsorbable synthetic mesh [6, 13, 14].
Functional results should be considered as important as anatomic outcomes. All
urinary symptoms decreased after surgery. The risk of new functional symptoms
was low, in particular, no de novo dyspareunia was observed. There are
conflicting reports regarding sexual function in patients who underwent
transvaginal polypropylene mesh surgery for pelvic organ prolapse [7, 15].
The surgical technique may be one of many underlying causes. In fact, wide
proximal vaginal dissection or dissection of prolapsed vagina after
hysterectomy could cause injury to distal pelvic perineal and cavernous nerves,
which reach the clitoral tissue, and lead to difficulty in achieving female
orgasm or satisfactory sexual activity. However, we believe that by avoiding
plication of fascial tissue or levator muscles and also by avoiding excision of
vaginal skin or mucosa, excessive folding and scarring in the anterior and
posterior compartments can be prevented.Salomon et al. used the transobturator route to secure the
anterior end of the implant for the repair of genital prolapse [16, 17],
and reported that among the nine patients who complained of cystocele with SUI,
seven were cured with no further treatment [16]. David-Montefiore et al.
found that of the 13 patients with preoperative SUI associated to genital
prolapse, 8 were cured following surgery [17]. The remaining five
women had improvement and did not require additional surgery [17]. In
our study, we found that transvaginal mesh with concomitant anti-incontinence TVT-O
procedure significantly decreased SUI and possibility of incontinence after the
correction of prolapse. All 16 patients with preoperative SUI were cured and no
patient of the remaining 4 developed incontinence after correction. These
results are in accordance those of Solà Dalenz et al. who demonstrated the
possibility to treat the prolapse and the incontinence simultaneously with two
meshes without adding morbidity [18]. We believe that the strategy for
management of concomitant SUI improves the results by the restoration of the
defective connection between the urethra and the vagina and, therefore, via the
reinforcement of the suburethral hammock.High recurrence rates of anterior vaginal wall prolapse with or
without the use of absorbable mesh have prompted most surgeons to use non-absorbable
materials such as polypropylene. However, polypropylene can cause foreign-body reactions,
infection, and erosion through the vagina. Reported rates of erosion associated
with polypropylene range from 2.1 to 25% [6, 19, 20]. A significant
number of these patients require reoperation for mesh removal. Analysis of the
first 100 Prolift vaginal mesh procedures revealed a 17.5% erosion rate, which
fells to 2.7% with limitation of the number and extent of colpotomies and
avoidance of concomitant hysterectomy and perineal incisions [20].  In our study, creation of vaginal flaps that
are thicker with an attached fibromuscularis, antibiotic prophylaxis, and
vaginal preparation with estriol reduced the mesh erosion rate.Sexual function may
be positively or negatively affected by vaginal operations for anterior vaginal
wall prolapse. The current popularity of synthetic or allograft mesh to augment
vaginal prolapse repairs could improve sexual function if cure rates improve or
could worsen function if vaginal stiffness, mesh erosions, or draining sinuses
result. More data with careful followup after surgery are needed.Efficacy and safety long-term trials are paramount prior to
widespread adoption. Emerging techniques must be compared with gold-standard
procedures in well-designed, long-term trials for anatomic and functional
outcomes.


## 5. Conclusions

These preliminary results suggest that tension-free vaginal mesh
(Prolift) placement by the transobturator route is a safe and effective
treatment for symptomatic anterior vaginal wall prolapse. Stress urinary
incontinence may be treated and avoided by simultaneously placing a transobturator
TVT-O without adding morbidity However, further studies are warranted to
determine long-term outcomes and to compare this approach with previously
accepted surgical procedures.



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