Association of urodynamics and lower urogenital tract nerve growth factor after synthetic vaginal mesh implantation on a rat model.

AIM: By investigating the association of urodynamics and urogenital nerve growth factor (NGF) levels in vaginal mesh surgery, we may be able to associate the likelihood of postoperative lower urinary tract symptoms developing as a result of synthetic mesh implanted for pelvic floor reconstructive surgery. METHODS: Thirty-eight female Sprague-Dawley rats were divided into three groups: mesh, sham (no mesh), and control. Urodynamic study and NGF analysis of the urogenital tissues were done and results were compared among all groups. The urodynamic studies of the mesh and sham groups were further divided into the 4th and 10th days. A P-value < 0.05 was considered statistically significant. RESULTS: All rats survived and no complications were observed during the post-implantation period. Histological evaluation showed intense acute inflammatory reaction on days 4 and 7 in the mesh and sham groups when compared to the control. The mesh group showed a larger area of inflammation as compared to the sham. The NGF levels increased significantly in the mesh and sham groups on the 4th and 10th days when compared to the control (P < 0.001, P < 0.001, respectively). Both the mesh and sham groups had shorter voiding interval and lower voiding volume on days 4 and 10 when compared to the control group (P < 0.001, P < 0.001, respectively). The magnitude on increasing NGF level and decreasing voiding interval and voiding volume was significantly more on the mesh group than the sham group. CONCLUSION: A higher level of NGF in the early days post-transvaginal mesh implantation is associated with a shorter voiding interval and a smaller bladder capacity, which represents abnormal lower urinary tract symptoms following transvaginal mesh implantation.

Clinical Relevance and Treatment Selection of Ureteral Injury After Cesarean Section.

INTRODUCTION: The aim of this case series was to report the clinical relevance and management outcomes of ureteral injuries acquired secondary to cesarean section. METHODS: This was a retrospective case series from January 2007 to September 2014. Description of the patients' characteristics, diagnostic tools for investigation, management, and postoperative follow-up was conducted on postcesarean section patients who developed symptoms of urine leakage after cesarean section and necessitated secondary surgery for ureteral injury. Descriptive statistics was used for demographics and operative data. RESULTS: A total of 5619 cases were managed by cesarean section during the study period. Six (0.107%; 95% confidence interval [CI], 0.1069%-0.1071%) patients had ureteral injury related to the cesarean section. Of 6 cases, 3 (0.053%; 95% CI, 0.0529%-0.0531%) had ureterouterine fistula. Three cases were managed by ureteroneocystostomy, 1 by ureteroneocystostomy with Boari flap, 1 by transureteroureterostomy, and the other one by ureteral stenting via ureterocystoscopy. Three patients had immediate operation because of an acute abdomen and 3 patients had delayed operation. The left ureter was the most common site of ureteral injury (5/6). The postoperative course was uneventful for all cases. CONCLUSIONS: Continuous urinary leakage and acute abdominal distention associated with fluid accumulation after emergency cesarean section should be considered as "red flag" symptoms of ureteral injury and ureterouterine fistulae complications. Delayed management for ureteral repair may not be associated with bad outcomes for management of ureterouterine fistula. Delayed management was associated with less blood loss, less operating time, and acceptable outcome among patients with ureterouterine fistulae when the renal function is not compromised.

Assessment of collagen versus non collagen coated anterior vaginal mesh in pelvic reconstructive surgery: prospective study.

OBJECTIVE: To evaluate the sonologic and clinical outcome of collagen coated (CC) versus non-collagen coated (NC) anterior vaginal mesh (AVM) for pelvic organ prolapse (POP) surgery. STUDY DESIGN: The study is a prospective observational study which included 122 patients who had symptomatic POP stage III and IV. AvaultaPlus™ (collagen coated, CC group) was compared to Perigee™ (non collagen coated, NC group). Introital ultrasound morphology, measure of neovascularization by color Doppler and clinical outcomes were assessed. Student t test was used for comparison of pre- and post-operation continuous data (p value of <0.05). RESULTS: A total of 110 (CC group=50, NC group=60) women completed the study. A woman in the CC group developed ureteral injury. Both groups had comparable morphologic and clinical outcomes however, the onset of changes in mesh thickness and neovascularization occurred earlier in the NC group (1 month) compared to the CC group (6 months to 1 year). CONCLUSION: CC group was comparable to the NC group in terms of erosion rate, ultrasound and clinical assessment. Collagen coating may induce delayed inflammatory response however may also delay tissue integration. The onset of changes in mesh thickness and neovascularization may give us an insight toward utilization of collagen coated mesh for host-tissue integration.

Clinical outcomes of mesh exposure/extrusion: presentation, timing and management.

BACKGROUND: The Food and Drug Administration has recently highlighted an increase in reported complications associated with the use of transvaginal mesh. AIMS: To describe the clinical outcomes, presentation, timing and management of mesh exposure/extrusion MATERIALS AND METHODS: Retrospective study from December 2006 to March 2012. A total of 40 women had vaginal mesh exposure/extrusion secondary to prior transvaginal mesh (TVM) surgery. Descriptive statistics were used for demographics and pre-operative data. Paired-samples t-test was applied for comparison of pre- and postoperation. A P value of <0.05 was considered statistically significant. RESULTS: The mesh exposure/extrusion rate was noted to be 2.64% (17/642). Vaginal bleeding in 29 of 40 (72.5%) and hispareunia in 12 of 13 (92.3%) were identified as the most common symptoms for mesh exposure/extrusion. The onset of complications occurred in two peaks: between 3 and 4 months and after 1-year of follow-up. Initial conservative treatment was given for 12.5% (5/40) of women, while 87.5% (35/40) had undergone repair for mesh exposure/extrusion (21 outpatient and 14 inpatient cases). Among those who had conservative treatment, 80% (4/5) had persistent mesh exposure. CONCLUSION: Persistent or new-onset abnormal vaginal bleeding and hispareunia after TVM surgery should be considered as 'red flag' symptoms for mesh exposure/extrusion. Frequent follow-up from the first 3-4 months up to 1 year postoperative may identify complications. Utilisation of mesh excision or trimming as the initial means of treatment may yield a better outcome.

Outcome after conservative management for mixed urinary incontinence.

AIM: Recommended initial treatment for mixed urinary incontinence involves behavioral therapy, and drug and pelvic floor muscle exercises. Our objective is to evaluate the outcome of these conservative treatments in our patients with mixed urinary incontinence. METHODS: A retrospective review was conducted in patients with mixed urinary incontinence who were offered sequential conservative treatment modalities comprised of medication and physiotherapy. Outcome was defined as a score of 1 or less for questions 2 and 3 on the six-item Urodynamic Distress Inventory (UDI-6) and seven-item Incontinence Impact Questionnaire, in addition to clinical symptomatic improvement with no urgency, urge incontinence and voiding frequency of less than eight times per 24 h on a 3-day bladder diary after treatment. Treatment outcome of patients opting for medication plus physiotherapy (M + P) were analyzed against patients preferring medication only (M). RESULTS: Sixty-two mixed urinary incontinent patients received an initial treatment with conservative measures with mean follow-up of 14 months. A total of 61.2% (30/49) and 56.3% (9/13) subjects had improved symptoms in the M + P and M group, respectively. There was significant improvement in UDI-6 total score in the M + P group after conservative treatment, despite no significant difference when compared to the M group. Only 6.45% required subsequent anti-incontinence surgery after conservative treatment, amongst whom only half showed improvement after the surgery. CONCLUSION: Combined treatment with medication and physiotherapy is highly recommended for patients with mixed urinary incontinence. Conservative measures should still precede any surgical intervention. Further studies are needed to evaluate the long-term efficacy.

Comparison between Elevate anterior/apical system and Perigee system in pelvic organ prolapse surgery: clinical and sonographic outcomes.

OBJECTIVE: The aim of this study was to assess the incidence of de novo stress urinary incontinence (SUI) and sonographic features of implanted transvaginal mesh in continent women treated with Elevate(™) anterior/apical [single-incision mesh (SIM-A)] or Perigee(™) [transvaginal mesh with sacrospinous fixation (TVM + SSF)] in extensive pelvic organ reconstruction surgery. METHODS: This prospective observational study was done from May 2010 to January 2013. Patients were recruited from two tertiary centers, and the Elevate(™) and Perigee(™) systems were compared. Patients who had overt or occult SUI, previous prolapse or mesh insertion were excluded. RESULT: Fifty-seven patients in the SIM-A group and sixty-one in the TVM + SSF group were analysed. All completed a minimum of 1-year follow-up. Groups were demographically and statistically similar. There was a significantly high incidence of de novo SUI postoperatively in the SIM-A group. The objective and subjective cure rate of pelvic organ prolapse (POP) were comparable between groups, with incidence of mesh erosion in the SIM-A group and three in the TVM + SSF group. Sonographic evaluation showed significant increase in mesh length in the SIM-A group. CONCLUSION: Elevate(™) a offered lower incidence of mesh erosion and comparable results on anatomical POP correction; however, incidence of de novo SUI was high. There is an apparent lengthening of implanted Elevate® mesh sonographically.

Anterior-apical single-incision mesh surgery (SIMS): surgical and functional outcomes at 1 year.

STUDY OBJECTIVES: To study the surgical and functional outcomes of single-incision mesh surgery for treatment of advanced pelvic organ prolapse (POP). DESIGN: Case series (Canadian Task Force classification II-3). SETTING: University hospital. PATIENTS: Sixty-five patients who underwent surgery to treat symptomatic POP greater than stage II according to the Pelvic Organ Prolapse Quantification System (POP-Q). INTERVENTION: All patients underwent anterior-apical single-incision mesh surgery using the Elevate Anterior and Apical Prolapse Repair System. MEASUREMENTS AND MAIN RESULTS: The primary objectives were anatomical correction of anterior and apical prolapse of POP stage I or greater and absence of voiding dysfunction reported via multi-channel urodynamic study at 6 months after surgery. Subjective outcome was measured via patient feedback using questions 2 and 3 of the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6). The secondary outcome was quality of life using the following: Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire 7 (IIQ-7), POPDI-6, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Two-dimensional introital ultrasonography was performed in the first and third months after surgery and at 1-year follow-up. Descriptive statistics were used for demographic and perioperative data. The paired-samples t test was used for comparison of preoperative and postoperative continuous data. For all comparisons, a value of p < .05 was considered statistically significant. All statistical methods were performed using commercially available software (SPSS version 17). Postoperative data were available for 64 patients. The objective outcome was 96.9%, and the subjective outcome was 93.8%. All patients demonstrated significant improvement in anatomical outcomes after prolapse surgery (p < .05), and none experienced recurrence requiring further surgery. There was concomitant significant improvement in POPDI-6, UDI-6, IIQ-7, and PISQ-12 scores after surgery. A subanalysis of POP quantification measurements immediately after surgery and at 1-year postoperative follow-up demonstrated deepening of the C point and total vaginal length. Ultrasound evaluation demonstrated a significant increase in the length and thickness of mesh at 1-year follow-up. There has been no documented mesh extrusion to date. However, the number of patients with stress urinary incontinence has increased. Four patients received treatment, whereas in the remaining patients the condition was not severe enough to require surgical intervention. CONCLUSIONS: Single-incision mesh surgery for treatment of advanced POP results in improvement in anatomical and quality-of-life outcomes. No mesh exposure was recorded in the first year after surgery; however, new onset of stress urinary incontinence may occur. Ultrasound evaluation demonstrated an increase in mesh length and thickness over time, with concurrent calculated lengthening of the C point and total vaginal length.

Ultrasonography and clinical outcomes following surgical anti-incontinence procedures (Monarc vs Miniarc).

OBJECTIVE: To evaluate the ultrasound morphology and its clinical outcome among women who had undergone Miniarc™ vs Monarc™ in the treatment of stress urinary incontinence (SUI). STUDY DESIGN: This was a prospective study on 140 patients with USI and undergone either Miniarc or Monarc surgery. From March 2010 to December 2011, patients with clinically SUI and urodynamic stress incontinence (USI) were included in the study. Objective cure of SUI was defined as no urinary leakage on provocative filling cystometry and 1-h pad test of <2 g. Subjective cure of SUI was the negative response to UDI-6. Introital ultrasound at one-year explored the sling and bladder neck's position, mobility, sling tension, percentile of urethra where the sling was located and urethral kinking. RESULTS: Postoperative data was available from 130 women. The ultrasound objective data for successful treatment post-operative follow-up was available from 119 women (46 Monarc, 73 Miniarc), the rest failed to follow-up. A bladder perforation was diagnosed in the Monarc group and 15 cases (7.1% of Monarc and 16.3% of Miniarc, p=0.082) of urinary retention was reported due to over-tensioning of the sling, majority of cases came from the Miniarc group. At rest and during Valsalva, analogous distances of the bladder neck and sling as well as the center of the urethral core were similar for both procedures. In both groups, shortest (Us) and longest diameters (Ul) of the urethral core were comparable at Valsalva which was significantly shorter and longer, respectively, compared to the values at rest. Sling position and percentage of urethral kinking were similar. Statistical analysis failed to detect any significant difference between the two groups with regards to the objective and subjective cure (p>0.05). CONCLUSIONS: In conclusion, a Miniarc and Monarc exhibit similar mechanism of action with comparable subjective and objective clinical outcomes. Majority of urethral impingement was noted in the Miniarc group. A higher maximum urethral closure pressure (MUCP), longer resting Ul, and shorter resting Us suggested these observations. Postoperative ultrasonographic evaluation may give a promising future perspective for the evaluation of sling tension.

Assessment of collagen-coated anterior mesh through morphology and clinical outcomes in pelvic reconstructive surgery for pelvic organ prolapse.

STUDY OBJECTIVE: To assess the morphologic features of anterior armed transobturator collagen-coated polypropylene mesh and its clinical outcomes in pelvic reconstructive surgery to treat pelvic organ prolapse. DESIGN: Evidence obtained from several timed series with intervention (Canadian Task Force classification II-3). SETTING: Chang Gung Memorial Hospital, Taoyuan, Taiwan, China. PATIENTS: Between April 2010 and October 2012, 70 patients underwent surgery to treat symptomatic pelvic organ prolapse, stage III/IV according to the POP-Q (Pelvic Organ Quantification System). INTERVENTION: Anterior armed transobturator collagen-coated mesh. MEASUREMENT AND MAIN RESULTS: Morphologic findings and clinical outcome were measured. Morphologic features were assessed via 2-dimensional introital ultrasonography and Doppler studies. Clinical outcome was measured via subjective and objective outcome. Objective outcome was assessed via the 9-point site-specific staging method of the International Continence Society Pelvic Organ Prolapse Quantification before the operation and at 1-year postoperative follow-up. Subjective outcome was based on 4 validated questionnaires: the 6-item UDI-6 (Urogenital Distress Inventory), the 7-item IIQ-7 (Incontinence Impact Questionnaire), the 6-item POPDI-6 (Pelvic Organ Prolapse Distress Inventory 6), and the 12-item PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire), at baseline and at 12 months after the operation. Data were obtained for 65 patients who underwent the combined surgery and were able to comply with follow-up for >1 year. Ultrasound studies reveal that mesh length tends to shorten and decrease in thickness over the 1-year follow-up. Vagina thickness also was reduced. Neovascularization through the mesh was observed in <8.5% of patients in the first month and at 1 year, and was evident in approximately 83%. The mesh exposure rate was 6.4%. The recorded objective cure was 90.8% (59 of 65 patients), and subjective cure was 89.2% (58 of 65 patients) at mean (SD) follow-up of 19.40 (10.98) months. At 2 years, UDI-6, IIQ-7, and POPDI-6 scores were all significantly decreased (p < .001), whereas the PISQ-12 score was significantly increased (p = .01). CONCLUSIONS: Ultrasound features suggest that the degeneration of collagen barrier may be longer than expected and that integration of collagen-coated mesh could occur up to 1 year. A substantially good clinical outcome was noted.