Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: The optimal number of onabotulinumtoxinA injections for the treatment of refractory overactive bladder syndrome is unknown. Our primary objective was to determine whether 10-injections sites with 100 units of onabotulinumtoxinA each were associated with less pain than 20-injections sites. METHODS: In a single-blinded randomized trial, 100 units of onabotulinumtoxinA was administered, either as 10 × 1 ml or as 20 × 0.5 ml injections following the instillation of 30 ml of bupivacaine and 5 ml of NaHCO3 solution for 15 min. The primary outcome was procedural pain, as measured on an 11-point Numerical Pain Rating Scale (NPRS) immediately following the procedure. A power calculation estimated that 16 subjects in each arm were needed to detect a mean difference of 1 with a standard deviation of 1, on the NPRS score between the two treatment groups, with α 0.05 and power 80%. To adjust for an estimated 20% dropout rate, the final sample size was planned for 20 patients per group. RESULTS: From October 2020 to November 2022, a total of 56 patients were approached and 40 were enrolled and randomized to two groups (21 in the 10-injections group and 19 in 20-injections group). The difference in the median pain score between the group was not statistically significant (4 [1.5-5] for 10 injections vs 3 [1-4] for 20 injections, p=0.823). CONCLUSION: Patients' perception of pain, efficacy, and adverse events did not significantly differ between patients receiving 10 and those receiving 20 injections of 100 units of onabotulinumtoxinA.

Financial analysis of minimally invasive sacrocolpopexy compared with native tissue vaginal repair with concomitant hysterectomy.

INTRODUCTION: Minimally invasive sacrocolpopexy (MISCP) is increasingly used for uterovaginal prolapse, but comparative cost data of MISCP versus native tissue vaginal repair (NTR) are lacking. The objective was to determine the cost difference, from a hospital perspective, between MISCP and NTR performed with hysterectomy for uterovaginal prolapse. METHODS: This was a retrospective cohort study at a tertiary care center of women who underwent NTR or MISCP with concomitant hysterectomy in 2021. Hospital charges, direct and indirect costs, and operating margin (revenue minus costs) were obtained from Strata Jazz and compared using SPSS. RESULTS: A total of 82 women were included, 33 MISCP (25 robotic, 8 laparoscopic) versus 49 NTR. Demographic and surgical data were similar, except that MISCP had younger age (50.5 vs 61.1 years, p<0.01). Same-day discharge and estimated blood loss were similar, but operative time was longer for MISCP (204 vs 161 min, p<0.01). MISCP total costs were higher (US$17,422 vs US$13,001, p<0.01). MISCP had higher direct costs (US$12,354 vs US$9,305, p<0.01) and indirect costs (US$5,068 vs US$3,696, p<0.01). Consumable supply costs were higher with MISCP (US$4,429 vs US$2,089, p<0.01), but the cost of operating room time and staff was similar (US$7,926 vs US$7,216, p=0.07). Controlling for same-day discharge, anti-incontinence procedures and smoking, total costs were higher for MISCP (adjusted beta = US$4,262, p<0.01). Mean charges (US$102,060 vs US$97,185, p=0.379), revenue (US$22,214 vs US$22,491, p=0.929), and operating margin (US$8,719 vs US$3,966, p=0.134) were not statistically different. CONCLUSION: Minimally invasive sacrocolpopexy had higher costs than NTR; however, charges, reimbursement, and operating margins were not statistically significantly different between the groups.

Chemokine therapy for anal sphincter injury in a rat model: a pilot study.

INTRODUCTION AND HYPOTHESIS: To determine whether delayed administration of CXCL12 alters anorectal manometric pressures and histology in rats following anal sphincterotomy compared to primary surgical repair alone. METHODS: Adult female rats were divided into three groups: A, a control group that did not undergo surgery; B, anal sphincterotomy with primary surgical repair; C, anal sphincterotomy with primary surgical repair and intra-sphincteric injection of CXCL12 at 6 weeks post-injury. All rats underwent anal manometry measurements at baseline and at 6 and 12 weeks post-injury. Histologic analysis of the anal sphincters was also performed. RESULTS: At baseline and 6 weeks, there were no statistically significant differences among D, Tmax and P∆ of Groups A, B and C. At 12-week manometry, the total duration of contractions on anal manometry was significantly less in Group C compared to Groups A and B (3.65, 5.5, 5.3 p < 0.01) as was time to peak of contraction at 12 weeks (1.6, 2.1, 3.1, p < 0.01); however, group C had a significantly higher P∆ at 12 weeks compared to Groups A and B (2.25, 1.4, 0.34, p < 0.01). There were no statistically significant differences in the ratio of muscle to collagen at the site of injury; however, muscle fibers were significantly smaller in group C and less per bundle than the other groups. CONCLUSIONS: Administration of chemokine therapy at 6 weeks post-repair using CXCL12 enhanced the magnitude of anal sphincter contractions in a rat model of anal sphincter injury but decreased overall duration of contraction. Increased anal sphincter contraction magnitude was not explained by histologic differences in explanted specimens.

Mesh Exposure Following Vaginal Versus Laparoscopic Hysterectomy at the Time of Sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: To compare vaginal mesh exposure rates, adverse events and composite failure within 1 year postoperatively in patients who undergo vaginal hysterectomy with vaginal mesh attachment (TVH) versus laparoscopic hysterectomy with abdominal mesh attachment (TLH) for minimally invasive sacrocolpopexy. METHODS: This multicenter retrospective cohort study is a secondary analysis of data collected retrospectively at one institution and the multicenter randomized control PACT trial. Women were excluded for no follow-up between 9 months and 2 years postoperatively or undergoing concurrent non-urogynecologic procedures. RESULTS: Between 2010 and 2019, 182 patients underwent TLH and 132 TVH. There were 15 (4.8%) vaginal mesh exposures: 12 (6.6%) in the TLH and 3 (2.3%) in the TVH group (p = 0.133) with zero mesh erosions. Logistic regression analysis for mesh exposure in the TLH vs. TVH groups controlling for BMI, posterior repair and surgeon training also showed no significant difference (OR 4.8, 95% CI 0.94, 24.8, p = 0.059). The overall intraoperative complication rate was low (19/314, 6.1%) with a higher rate of bladder injury in the TLH group (4.4% vs. 0.8%, p = 0.049). The TLH group had a higher rate of UTI (8.2% vs. 2.3%, p = 0.027) and clean intermittent catheterization (11% vs. 3%, p = 0.009). At 1-year follow-up, there was no difference in composite failure (6%), bulge symptoms (5%) or retreatment (1%) between groups. CONCLUSIONS: At 1 year, there is no significant difference in vaginal mesh exposure rates between vaginal hysterectomy with vaginal mesh attachment and laparoscopic hysterectomy with abdominal mesh attachment. Both groups have equal efficacy with low rates of complications.

Voiding function after sacrocolpopexy versus native tissue transvaginal repair for apical pelvic organ prolapse in an ERAS era: A retrospective cohort study.

OBJECTIVE: The objectives of this study were to compare time to return of voiding function and associated complications in women undergoing minimally invasive sacrocolpopexy (SCP) versus transvaginal native tissue repair in patients with same-day or early discharge. METHODS: This was a retrospective cohort study conducted at a tertiary care center. The electronic medical record system was queried for women who underwent native tissue vaginal repair or SCP for apical prolapse between March and December 2020 using CPT codes for sacrocolpopexy (57425), extraperitoneal (57282), and intraperitoneal colpopexy (57283). Voiding success was our primary outcome and was defined by a postvoid residual < 150 ml. Secondary outcomes included catheter days and urinary tract infections. The total number of participants was based on a power calculation using internal institutional rates. Participants were compared based on the surgical approach. A multivariate regression analysis was performed to assess for confounding factors. RESULTS: We included 134 women: 63 SCP and 71 native tissue. The failure rate of the first postoperative voiding trial was 34 vs. 11% (odds ratio: 4.91; 95% CI 1.96-12.3, p < 0.01) in the vaginal and SCP groups, respectively. Both groups had a similar success rate of a second voiding trial (100% in SCP group vs. 95.7% in the vaginal repair group, p = 1). The total number of days (3.108 vs. 1.603 days, p < 0.01) to return of bladder function, postoperative urinary tract infections (23.9 vs. 6.35%, p < 0.01) and emergency department visits (15.5 vs. 1.59%, p < 0.01) were all higher in the vaginal repair group. CONCLUSIONS: Vaginal apical native tissue repair had a fivefold greater risk of acute postoperative urinary retention compared to sacrocolpopexy in addition to increased rates of post-operative urinary tract infection and emergency department visits for urinary tract concerns.

Validation of an educational simulation model for vaginal hysterectomy training: a pilot study.

INTRODUCTION AND HYPOTHESIS: The Miya Model ™ (Miyazaki Enterprises, Winston-Salem, NC, USA) was designed as a realistic vaginal surgery simulation model. Our aim was to describe this model and present pilot data on validity and reliability of the model as an assessment tool of vaginal hysterectomy skills. METHODS: We video recorded ten obstetrics and gynecology residents (novice group) and ten practicing gynecologists (expert group) performing vaginal hysterectomy using the Miya model. Blood loss and time taken to complete the procedure were documented. Participants evaluated the model using a postsimulation survey. In addition, two experienced gynecologic surgeons independently evaluated video recordings of each participant's performance using two previously validated global rating scales: Reznick's Objective Structured Assessment of Technical Skill (OSATS) and Vaginal Surgical Skills Index (VSSI). RESULTS: Most participants (80% of novice and 100% of expert group) rated the model as effective or highly effective for vaginal hysterectomy training and assessment. Median time to procedure completion was significantly higher in the novice group, whereas median estimated blood loss was no different between groups. No significant differences were observed in the composite median OSATS or VSSI scores between groups. The interrater reliability indices for subscales and composite scores of the OSATS and VSSI were high and ranged from 0.79 to 0.90 and 0.77 to 0.93, respectively. CONCLUSIONS: With further study, the Miya Model may be a useful tool for teaching and assessing vaginal surgical skills.

Neoadjuvant chemotherapy and primary debulking surgery utilization for advanced-stage ovarian cancer at a comprehensive cancer center.

OBJECTIVE: The aim of this study was to evaluate the use of neoadjuvant chemotherapy (NACT) and primary debulking surgery (PDS) before and after results from a randomized trial were published and showed non-inferiority between NACT and PDS in the management of advanced-stage ovarian carcinoma. METHODS: We evaluated consecutive patients with advanced-stage ovarian cancer treated at our institution from 1/1/08-5/1/13, which encompassed 32 months before and 32 months after the randomized trial results were published. We included all newly diagnosed patients with high-grade histology and stage III/IV disease. Associations between the use of NACT and clinical variables over time were evaluated. RESULTS: Our study included 586 patients. Median age was 62 years (range, 30-90); 406 patients (69%) had stage III disease, and 570 (97%) had disease of serous histology. Twenty-six percent (154/586) were treated with NACT and 74% (432/586) with PDS. NACT use increased significantly from 22% (56/256) before 2010 (at which point the results of the randomized trial were published) to 30% (98/330) after 2010 (p=0.037). Although patients who underwent PDS were more likely to experience grade 3/4 surgical complications than those who underwent NACT, those selected for PDS had a median OS of 71.7 months (CI, 59.8-not reached) compared with 42.9 months (CI 37.1-56.3) for those selected for NACT. CONCLUSIONS: In this single-institution analysis, the best survival outcomes were observed in patients who were deemed eligible for PDS followed by platinum-based chemotherapy. Selection criteria for NACT require further definition and should take institutional surgical strategy into account.