Introduction 24 months of follow up, P

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.