Introduction and Hypothesis: We
evaluate the 2 years outcome of Rolled Fortified Vaginal Flap (RFVF) operation
for the treatment of stress urinary incontinence (SUI) due to intirinsic
sphincteric deficiency (ISD).
Methods: A prospective
study of twenty women suffering from SUI due to ISD was conducted. All patients
were subjected to history taking, clinical examination, cough stress test, Q
tip test, and urodynamics. Quality of life (QoL) was assessed using the Arabic
version of the International Consultation on Incontinence Questionnaire –
Urinary Incontinence – Short Form (ICIQ-UI SF). All studied women were followed
up for a mean period of 24 months to detect success rate, any postoperative
complication, and reveal changes in the quality of life.
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Results: Mean age was
43 + 8.7 years. Preoperative Valsalva leak point pressure was 50.1 +
11.3 cmH2O. After a follow up period of 24 months, only 2 patients
(10%) showed mild stress incontinence with mean VLPP 80+ 3 cmH2O. Mean
maximum flow rate (Q-max) slightly decreased, but this wasn’t significant (P =
0.115). Max Pdet pressure showed a slight and insignificant increase (P =
0.187). The overall mean ICIQ-UI-SF score decreased from 73.5 + 12.1%
(preoperative) to 2.6 + 8.1% (1 year after follow up) and then showed
slight increase to 4.5 + 10.6 at 24 months of follow up, P < 0.001.
Conclusion: Rolled
Fortified Vaginal Flap (RFVF) operation has a success rate of 90% at 24 months
follow up. It significantly improved the quality of life of women with SUI due
to ISD.
Key Word: Stress
urinary incontinence - Rolled Fortified Vaginal Flap - Quality of
life
- Urodynamics
Abstract word count: 249
Brief Summary:
Rolled Fortified Vaginal Flap for treatment of intrinsic
sphincteric deficiency is safe, effective and improved the patients' quality of
life after 2 years follow up.
Introduction:
Stress urinary incontinence is the primary type of urinary
incontinence reported among younger women, with approximately 50% of urinary
incontinence being stress (1). It is defined as the
involuntary loss of urine during coughing, sneezing or physical exertion. The
overall prevalence of incontinence tends to increase in young adulthood, with a
steady increase seen among elderly women (2,3). This problem affects the
physical, mental, and sexual aspects of women and causes deprivation of social
status and decreases quality of life (4,5). In addition, it produces serious economic and
psychological problems with feelings of helplessness, depression, and anxiety (6).
At 1980, McGuire et al (7) recognized
the importance of urodynamic evaluation, which highlighted the concept of
intrinsic sphincter deficiency (ISD) as an important factor in the etiology of
stress incontinence. McGuire et al observed that some patients in whom multiple
retropubic operations failed had a deficient sphincteric mechanism
characterized by an open vesical neck and proximal urethra at rest, with
minimal or no urethral descent during stress. This led to the classification of
stress incontinence into mild and moderate (due to urethral hypermobility) and
severe (due to ISD).
For mild and moderate degrees of SUI, midurethral tapes are
commonly used with high degree of success and minimal postoperative
complications (8). On the other hand, severe cases of SUI due to intrinsic
sphincteric deficiency (ISD) are usually treated by bladder neck slings using biological
or synthetic materials, injectables, or artificial urinary sphincter (9).
However, the use synthetic materials carry the risk of erosion and
postoperative voiding dysfunction (10). Moreover, synthetic slings and
artificial sphincter are expensive and may not be affordable for patients in
low income countries. Thus, the current
study was conducted to evaluate the use of Rolled Fortified Vaginal Flap (RFVF)
operation in the treatment of stress urinary incontinence (SUI) due to ISD addressing
its technical feasibility, complications, outcome, and its impact on the
quality of life of those women.
Patients and methods:
After institutional review board approval, this prospective study
was conducted on 20 female patients suffering from Stress Urinary Incontinence
(SUI) due to Intrinsic Sphincter Deficiency (ISD) admitted to the Urology
Department, Main Alexandria University Hospital. Patients with clinical overactive
bladder (OAB), neurogenic bladder and/or pelvic organ prolapsed (POP) were
excluded.
All patients were submitted to history taking with objective
evaluation using the Arabic version of the International Consultation on
Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI SF) to
assess the degree of affection of urinary incontinence on the patient's quality
of life (QOL)(11,12) Appendicies 1&2 . This was followed by clinical examination in the form of abdominal
examination and vaginal examination to exclude POP. Special tests were used to
detect SUI in the form of: Cough stress test, Q tip test and Urodynamics. Filling
cystometry was done to detect degree of VLPP starting from 200 ml bladder
capacity, then repeated every 100 ml. Bladder capacity, compliance, sensations
and detrusor over-activity were also assessed. Pressure-flow studies were done
to detect changes in urinary flow rate, voiding pressure and detrusor pressure
at maximum flow (Pdet Qmax) that may indicate postoperative bladder outlet
obstruction. (13)
Operative Technique:
Rolled Fortified Vaginal Flap (RFVF) procedure was performed for
all patients. The procedure was done under spinal anesthesia in the dorsal
lithotomy position. A urethral catheter is inserted to keep the bladder empty
at all times. A rectangular anterior vaginal wall flap is fashioned such that
the top of the flap is approximately 2 centimeters below the urethral meatus
and the bottom of the flap is extended towards the bladder neck (Fig i).
Cauterization of the surface of the vaginal flap is done; this is followed by
placement of two diagonal rows of zero prolene sutures within the flap to
reinforce it (Fig ii). The next step is enrolling of the flap. The rolled flap
is now suspended by two threads from either side (Fig iii) that are passed into
the suprapubic region using Stamey needles from above through two abdominal
incisions. The 2 sutures are tied above the rectus sheath and are tied to each
other (Fig iv).
Follow up visits were conducted periodically at 6, 12 and 24 months
postoperatively and included history taking with questionnaire, clinical
examination and urodynamic evaluation. Success was defined as being dry at the
follow up visits without complications. Data were fed to the computer using
Statistical Package for Social Science (SPSS, version19). For comparative
purposes, paired t-test was utilized to compare pre- and post-operative
quantitative variables. Friedman test was utilized to compare pre- and
post-operative Qol score variables measured more than two times. Kendall's test
was utilized to measure pre- and post-operative qualitative variables.
Appropriate inferential statistics was done with ? 0.05 level of significance.
Results:
Age of studied women ranged from 20 to 58 years with a mean of
43.00 + 8.7 years. Gravidity ranged from 1 to 8 with a mean of 3.8 +
1.8, while parity ranged from 1-6 with a mean of 2.8 + 1.1. All the
studied women had at least one normal delivery, while three of them were
subjected to caesarean section. One woman had previous failed vaginal tape and
another one had total hysterectomy.
As expected all studied women had a positive cough test. Women with
positive urethral hypermobility constituted 45% (9) of the studied women. Preoperative urodynamic examination revealed that
Valsalva leak point pressure (VLPP) ranged from 20 to 58 cm H2O with
a mean of 50.05+8.2 cm H2O. Postoperatively, the success rate
was 90% based on our definition of clinical success (Dry women at follow up
with negative VLPP and no major complications) (Table 1). Stress Urinary
incontinence (SUI) was observed among three cases (15%) immediately
postoperatively, one of them could be corrected successfully by suprapubic
suture adjustment under local anesthesia.
The other 2 patients (10%) remained with SUI at 24 months follow up but
with a milder degree than before surgery (VLPP 80+ 3 cmH2O).
As regards postoperative complications, transient retention of
urine was observed immediately post operatively in only one women (5%) and
relieved by temporary urethral catheter, while no women suffered such symptom during
the whole period of follow up (P = 0.007). Four cases (20%) suffered from mild
urinary obstructive symptoms at 6 month of follow up. This number decreased to
just only 2 cases (10%) after 12 months of follow up.
Postoperative urodynamic evaluation revealed that mean maximum flow
rate (Qmax) slightly decreased from 23.1 + 4.6 ml/s preoperatively to 22.2
+ 3.5 ml/s, 21+ 3.4 ml/s and 19.1+ 2.2 ml/s at 6 months,
12 months and 24 months postoperatively, respectively. However, this decrease was
not statistically significant, P = 0.115. Max Pdet pressure showed a slight and
insignificant increase; as the studied women had a mean of 30.85 + 4.04 cmH2O
at 6 month of follow up and 33.17 + 3.88 cmH2O at 24 months follow up
compared to 28.1+ 3.2 cmH2O preoperatively (P = 0.187). (Table 1)
The ICIQ-UI SF score showed a significant improvement from a mean
percent score of 73.5 +12.1% preoperatively to 2.6 +8.09% at 6 months and 12 months follow up , then
showed little increase to 4.5+ 10.6 at 24 month follow up (P < 0.001).
(Table 1)
Discussion:
The goal of treatment for intrinsic sphincteric deficiency (ISD) is
to correct incontinence without creating outlet obstruction. Management of
intrinsic sphincteric deficiency generally falls into 1 of 3 categories: urethral
bulking agents, slings or artificial urinary sphincter. The pubovaginal sling
remains the gold standard of therapy for the surgical candidate with a long
term success rate up to 95%. (9) The transvaginal tape (TVT) procedure has
become one of the most popular techniques for treating SUI because of its ease
and effectiveness. A published series with a long follow-up duration showed
good continence rates after the TVT procedure (14). However, there is a
controversy about the long term efficacy of the TVT procedure in women with
ISD. Doo et al reported five year follow-up results of 31 patients with VLPP
below 60 cmH2O. Cure rates were 51.6% and the success rate of the ISD group was
significantly lower (15). Paick et al also reported significantly low
success rate in the group below 60 cmH2O compared the group above 60 cmH2O
(82% vs. 93.1%, P = 0.013) (16). In our series, RFVF showed 90% success rate at
2 years follow up which is comparable to the gold standard pubovaginal slings
(95%). However, still a longer follow up period of a larger group of patients
is needed.
Postoperative bladder outlet obstruction is a crucial problem after
anti-incontinence surgery. In our study, only one patient had transient
postoperative retention and 20% suffered from obstructive urinary symptoms 6
month following surgery, which decreased to only 10% later on. This reflects the
low incidence of obstruction after RFVF operation. For the gold standard bladder
neck sling operation, the reported incidence of postoperative obstruction
reached up to 30% (9).
One of the advantages of RFVF is the cost effectiveness of the
technique as it uses local tissues rather than external commercial devices like
the synthetic sings or artificial sphincter that are rather expensive. This is
very important in low income countries where the cost of the operation plays a
role in decision making. Another advantage is the zero incidence of vaginal
erosion or bladder perforation as there is no synthetic foreign material used.
Incontinence is considered as the main factor affecting quality of
life of women following surgery. Measuring QoL with different instruments poses
some challenges, namely: which is the better tool to assess patient oriented
outcomes? The ICIQ, used in the current study, is a brief 3-scored and
1-unscored self diagnostic item that assesses the prevalence, frequency and
volume of leakage as well as the QoL impact. The
ICIQ demonstrates good construct validity and reliability and high correlation
with the Sandvik severity index (17).
This study offered a unique opportunity to prospectively compare
quality of life for 24 months postoperatively. In this study the ICIQ score
improved from 73.57 + 12.015% (preoperative) to 2.62 + 8.098% (6
month after follow up) and then maintained at the same score at 12 months of
follow up, then showed little increase at 24 month follow up (4.5+ 9.3);
P < 0.001. Data from this study are consistent with prior findings that QoL
after SUI surgery is observed after a variety of surgical approaches including
Burch retropubic urethropexy, traditional sling operations, and mid-urethral
slings. Most reports support roughly a 70% to 80% improvement that is sustained
over time. (18,19)
Strengths of this study include the prospective design of the trial
and condition-specific measures of QoL. However, limitations of this study
include the lack of a control arm for a randomized controlled study and the
small number of patients included. Also, a longer duration of follow up would
better demonstrate the sustainment of the observed success and improvement in
the quality of life.
Conclusion
Rolled Fortified Vaginal Flap (RFVF) is a safe and cheap procedure
for treatment of female intrinsic sphincteric deficiency. It carries high
success rate and leads to improvement of the patients' quality of life after 2
years follow up.
