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The effect of stress urinary incontinence in women with mixed urinary incontinence on catheterization rates following intradetrusor onabotulinumtoxina injection: Benefit or burden? [Meeting Abstract]

Brandon, C; Glass, D; Oh, C; Kreines, F; Thakker, S; Brucker, B M; Rosenblum, N; Nitti, V W; Malacarne, Pape D
Objective: Intradetrusor onabotulinumtoxinA (ONA) is an effective treatment for urgency urinary incontinence (UUI). A possible adverse effect of ONA is incomplete bladder emptying requiring temporary clean intermittent catheterization (CIC). The goal of this study was to determine whether uncorrected patient-reported stress urinary incontinence (SUI) in those with urgency predominant mixed urinary incontinence (MUI) had an effect on CIC rates.
Method(s): This was a retrospective chart review conducted at a single academic institution between 1/2010 and 12/2019. Unique female subjects were identified by CPT and/or J codes for intradetrusor injection of ONA. Charts were reviewed for demographic information, past medical and surgical history, symptoms of SUI, post void residual (PVR) before and after ONA injection, and whether catheterization was required after index ONA 100 unit injection. Subjects with a diagnosis of neurogenic bladder, urethral stricture, and baseline catheterization requirement were excluded from this analysis. Anti-stress incontinence (ASI) procedures were historic as documented in urogynecologic history prior to index ONA injection. CIC was at the discretion of the clinician, typically with CIC recommended if PVR>350 mL. Patient characteristics and CIC rates were analyzed using descriptive statistics after assessing for normality. Two-sided P values <0.05 were considered to be statistically significant.
Result(s): Of 517 charts, 178 females were included for analysis. The mean age of women was 68.63 (+/-15.2) years. A total of 78 (41.6%) women had UUI but no SUI, 57 (32.0%) reported SUI along with UUI (ie, MUI) without any prior ASI procedure, and 47 (26.4%) reported SUI with prior ASI procedure. Demographic and outcome data are demonstrated in table 1. The overall CIC rate following ONA was 11.23%. We found that a lower proportion of women with uncorrected SUI required CIC following ONA compared to women without SUI or women with previous ASI procedure (P=0.017). The pre-ONA PVR was not significantly different between all three groups (P=0.12) while the post-ONA PVR was significantly higher among women with prior ASI procedure (P<0.001).
Conclusion(s): Rates of CIC are lower among women with uncorrected SUI, despite an overall significantly older population and similar baseline PVRs. This would suggest that a decreased outlet resistance may be protective against urinary retention. This is an important finding to consider when counseling our patients on the risks and benefits of ONA for the treatment of urge-predominant mixed urinary incontinence
EMBASE:633958692
ISSN: 2154-4212
CID: 4789322

Rectus Fascia Versus Fascia Lata for Autologous Fascial Pubovaginal Sling: A Single-Center Comparison of Perioperative and Functional Outcomes

Peng, Michelle; Sussman, Rachael D; Escobar, Christina; Palmerola, Ricardo; Pape, Dominique M; Smilen, Scott S; Rosenblum, Nirit; Brucker, Benjamin M; Peyronnet, Benoit; Nitti, Victor W
OBJECTIVE:To compare perioperative and functional outcomes of autologous fascia lata versus rectus fascia pubovaginal sling in female patients with stress urinary incontinence (SUI). METHODS:The charts of all patients undergoing pubovaginal sling for SUI from 2012 to 2017 at a single center were retrospectively reviewed. Patients were divided into 2 groups: those with the sling harvested from the fascia lata (FL group) and those with the sling harvested from the rectus fascia (RF group). RESULTS:Between 2012 and 2017, 105 women underwent pubovaginal slings: 21 using FL and 84 using RF. Operative time did not differ significantly between the FL and RF groups (84 vs 81.9 minutes; P = 0.68). Estimated blood loss was lower in the FL group (91.7 vs 141.6 mL; P = 0.04). There were more wound complications in the RF group, although this was not statistically significant (0% vs 14.3%; P = 0.12). Overall complications were comparable between FL and RF groups (52.4% vs 48.9%; P = 0.81), but the proportion of Clavien grade 2 or greater were higher in the RF group (4.8% vs 20.2%; P = 0.11). Overall, wound complications accounted for 29.3% of postoperative complications in the RF group (12/41). Functional outcomes were comparable between FL and RF groups, with similar rates of patients without SUI symptoms after 1 month (82.4% vs 76.4%; P = 0.74), 1 year (55.6% vs 63.8%; P = 0.76), and at the latest follow-up (66.7% vs 65.8%; P = 0.87). CONCLUSIONS:When compared with rectus fascia for pubovaginal sling, fascia lata may decrease perioperative morbidity, especially wound complications, without compromising functional outcomes.
PMID: 31343622
ISSN: 2154-4212
CID: 3987442

Impact of preoperative urodynamics on women undergoing pelvic organ prolapse surgery

Glass, Dianne; Lin, Frank C; Khan, Aqsa A; Van Kuiken, Michelle; Drain, Alice; Siev, Michael; Peyronett, Benoit; Rosenblum, Nirit; Brucker, Benjamin M; Nitti, Victor W
INTRODUCTION AND HYPOTHESIS/OBJECTIVE:Preoperative urodynamic studies (UDS) are frequently performed before pelvic organ prolapse (POP) surgery to assess urethral and bladder function. The primary goal of this study is to examine how preoperative UDS are utilized and what value these studies have in patient treatment and/or counseling. METHODS:We retrospectively reviewed patients who underwent prolapse surgery and had preoperative UDS between June 2010 and February 2015. Indications for UDS were classified into four categories: (1) occult stress urinary incontinence only, (2) overactive bladder symptoms, (3) mixed or insensible urinary incontinence, and (4) voiding symptoms and/or elevated post-void residual. We identified changes in management or counseling that were directly attributable to UDS results prior to surgery. RESULTS:Three hundred ninety-two patients underwent urodynamic testing for indications 2-4 above, and 316 met the inclusion criteria. Fifty-seven percent (180/316) had OAB symptoms (34.4% wet, 65.6% dry), 40.2% (127/316) had mixed incontinence, and 17.1% (54/316) had voiding symptoms and/or elevated PVR. A total of 3.5% (11/316) patients had alteration in their management or counseling based on the results of the UDS; 29.4% (50/170) of the women evaluated for occult SUI alone or with other symptoms demonstrated it and 41 underwent sling placement. CONCLUSIONS:UDS did not have a significant impact on preoperative management or counseling in POP surgery if demonstration of occult SUI was not the indication for preoperative study in women committed to POP surgery. Major alterations in treatment were rare and occurred mostly in women with stress incontinence that also had concomitant voiding symptoms and/or elevated PVR.
PMID: 31456030
ISSN: 1433-3023
CID: 4092412

Current Role of Urethrolysis and Partial Excision in Patients Seeking Revision of Anti-incontinence Sling

Drain, Alice; Enemchukwu, Ekene; Shah, Nihar; Syan, Raveen; Rosenblum, Nirit; Nitti, Victor W.; Brucker, Benjamin M.
SCOPUS:85092146889
ISSN: 0029-7828
CID: 4648332

Radiation exposure during videourodynamic testing: Is dose reduction possible using a standardized protocol?

Hoffman, Daniel; Sussman, Rachael D; Pape, Dominique M; Smilen, Scott W; Rosenblum, Nirit; Nitti, Victor W; Brucker, Benjamin M
AIMS/OBJECTIVE:To evaluate the impact of a protocol for standardized image capture during video urodynamics (VUD) on radiation exposure. Secondly, to categorize radiation exposure by condition warranting VUD and to identify clinical variables that correlate with increased radiation exposure. METHODS:One hundred fifty patients underwent VUD using our standardized protocol. All images were taken using low dose and pulsed settings. Four images are captured: one scout image, one filling image, one voiding image, and one post-void image. If the patient is unable to void with the catheter in place, the catheter is removed and a second image is taken during an attempt at unintubated flow. If vesicoureteral reflux (VUR) is identified, an alternate protocol is entered to document parameters. The mean radiation exposure measured in dose area product (DAP), fluoroscopy time, and number of images were noted and compared with previously published fluoroscopy data collected at our institution before protocol implementation. RESULTS:taking 5.2 images in 4.5 seconds. Protocol implementation leads to a 51.2% reduction in radiation exposure calculated by mean DAP (P < .0001) and a 96.5% reduction in fluoroscopy time (P < .0001). The presence of VUR, fluoroscopy time, and body mass index (BMI) > 25 were associated with higher radiation exposure (P < .0001). CONCLUSION/CONCLUSIONS:Implementation and adherence to a standardized protocol for fluoroscopy led to a reduction in radiation exposure fluoroscopy time. The presence of VUR, fluoroscopy time, and BMI > 25 were associated with higher radiation exposure.
PMID: 31846117
ISSN: 1520-6777
CID: 4242412

Evaluating the safety and potential activity of URO-902 (hMaxi-K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non-neurogenic) overactive bladder syndrome and detrusor overactivity from two double-blind, imbalanced, placebo-controlled randomized phase 1 trials

Rovner, Eric; Chai, Toby C; Jacobs, Sharon; Christ, George; Andersson, Karl-Erik; Efros, Mitchell; Nitti, Victor; Davies, Kelvin; McCullough, Andrew R; Melman, Arnold
AIMS/OBJECTIVE:Two phase 1 trials were performed in healthy women with the overactive bladder (OAB) syndrome and urodynamically demonstrated detrusor overactivity (DO), with the aim to demonstrate the safety and potential efficacy of URO-902, which comprises a gene therapy plasmid vector expressing the human big potassium channel α subunit. METHODS:ION-02 (intravesical instillation) and ION-03 (direct injection) were double-blind, placebo-controlled, multicenter studies without overlap in enrollment between studies. Active doses were administered and evaluated sequentially (lowest dose first) for safety. ION-02 participants received either 5000 µg or 10 000 µg URO-902, or placebo. ION-03 participants received either 16 000 or 24 000 µg URO-902, or placebo, injected directly into the bladder wall using cystoscopy. Primary outcome variables were safety parameters occurring subsequent to URO-902 administration; secondary efficacy variables also were evaluated. RESULTS:Among the safety outcomes, there were no dose-limiting toxicities or significant adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs. For efficacy, in ION-02 (N = 21), involuntary detrusor contractions on urodynamics at 24 weeks in patients receiving URO-902 (P < .0508 vs placebo) and mean urgency incontinence episodes in the 5000 µg group (P = .0812 vs placebo) each showed a downward trend. In ION-03 (N = 13), significant reduction versus placebo in urgency episodes (16 000 µg, P = .036; 24 000 µg, P = .046) and number of voids (16 000 µg, -2.16, P = .044; 24 000 µg, -2.73, P = .047) were observed 1 week after injection. CONCLUSION/CONCLUSIONS:Promising safety and efficacy results in these preliminary phase 1 studies suggest gene transfer may be a promising therapy for OAB/DO, warranting further investigation.
PMID: 31945197
ISSN: 1520-6777
CID: 4292552

Post-ptns trends-who commits? a prospective cohort study evaluating post-PTNS treatment in overactive bladder [Meeting Abstract]

Brandon, C; Brucker, B; Smilen, S; Rosenblum, N; Ferrante, K; Nitti, V; Malacarne-Pape, D
Introduction: Percutaneous tibial nerve stimulation (PTNS) is an efficacious treatment option for overactive bladder syndrome (OAB). There is a paucity of data surrounding long-term efficacy of PTNS and limited studies are aimed at characterizing those patients who seek post-PTNS follow up maintenance. The aim of this study was to evaluate those who completed PTNS treatment and continued with posttreatment PTNS maintenance versus alternative therapeutic options.
Method(s): This is a prospective cohort study at a single academic institution. Ninety patients started PTNS according to our clinical protocol. The Patient Global Impression of Severity (PGIS) and Patient Global Impression of Improvement (PGII), and OAB Short Form (OABq-SF) questionnaires were used to assess OAB symptom severity and improvement, respectively. Following 12 sessions, patients were given the choice to continue maintenance PTNS or to pursue other options.
Result(s): Our completion rate was 70/90 (77.8%). Of all patients who continued some type of therapy for OAB, significantly more patients went on to monthly PTNS maintenance compared with all other options (54.3% vs 37.1%, P=0.02). There were no differing demographic features between those who pursued Post-PTNS maintenance and those who chose an alternative therapy. Overall OABq-SF scores improved significantly by the end of treatment but did not differ between those who chose PTNS maintenance and those who pursued another treatment. Medications did not improve the perception of improvement when added to PTNS (P=0.45). Individuals who chose PTNS maintenance showed significant improvement in urgency (3.4 (0.89) to 2.6 (0.89); P=0.049) and incontinence (3.2 (1.72) to 2.7 (1.37); P=0.038) over the initial 12 weeks, while those who chose otherwise did not. Individuals who went on to monthly maintenance showed lower PGII scores compared with those who sought alternatives (2.70 (1.6) vs 3.81 (1.07); P=0.01), despite no difference in starting severity of OAB symptoms (PGIS score 3.33 (0.72) vs 3.33 (0.70); P=1).
Conclusion(s): Patients were more likely to continue maintenance PTNS than any other form of treatment. Despite no predictive characteristics found, favorable improvement subscores in urgency and incontinence were associated with those pursuing maintenance therapy. Overall, those who perceived greater improvement were more likely to pursue long-term PTNS therapy as their OAB treatment of choice
EMBASE:632157592
ISSN: 1520-6777
CID: 4549992

Current Role of Urethrolysis and Partial Excision in Patients Seeking Revision of Anti-Incontinence Sling

Drain, Alice; Enemchukwu, Ekene; Shah, Nihar; Syan, Raveen; Rosenblum, Nirit; Nitti, Victor W; Brucker, Benjamin M
OBJECTIVES/OBJECTIVE:Stress urinary incontinence is highly prevalent and sling surgery has increased since 2000. Urethrolysis traditionally had been standard management of complications after anti-incontinence surgery; however, partial excision is a less aggressive option. This study describes the different populations in a contemporary cohort that undergo sling excision and urethrolysis and their surgical outcomes. METHODS:Chart analysis was performed on patients assigned Current Procedural Terminology codes for removal or revision of sling for stress incontinence, urethrolysis, or revision of graft at our institution from 2010 to 2015. Demographics, indications, outcomes, and subsequent treatment were evaluated. RESULTS:A total of 110 patients underwent surgery and were included. Partial excision was performed on 82 patients and urethrolysis on 28 patients. About 32.7% had prior revision, and median length to revision was 3.1 years. Overall success was 75.0% for urethrolysis and 86.6% for partial excision. Without concomitant sling placement, stress incontinence developed in 25.0% of urethrolysis and 21.6% of partial excision patients. New onset overactive bladder symptoms developed in 21.4% of urethrolysis patients and 7.3% of partial excision, which was significantly different (P = 0.039). CONCLUSIONS:Both approaches had good success, 75.0% for formal urethrolysis and 86.6% for partial excision. New onset urgency was lower for partial excision, but rates of all other complications were similar. These procedures are often used for different patient populations, and thus, outcomes are not meant to be directly compared. Future work on sling revision should report these procedures separately.
PMID: 29787462
ISSN: 2154-4212
CID: 3165342

Exploring stress urinary incontinence outcomes after sling excision for perforation or exposure

Syan, Raveen; Peyronnet, Benoit; Drain, Alice; Enemchukwu, Ekene; Malacarne, Dominique R; Rosenblum, Nirit; Nitti, Victor W; Brucker, Benjamin M
OBJECTIVE:This study assessed stress urinary incontinence (SUI) outcomes after sling excision for urinary tract perforation or vaginal exposure, and compared the outcomes of concomitant versus staged autologous fascia pubovaginal sling (AFPVS). METHODS:A retrospective chart review of all patients who underwent midurethral sling (MUS) excision for urinary tract perforation or vaginal exposure at a tertiary referral center between 2010 and 2015 was performed. Therapeutic strategies were categorized as concomitant AFPVS, staged AFPVS, and no anti-incontinence procedure. RESULTS:In all, 32 patients were included for analysis: 13 with vaginal tape exposure (40.6%) and 19 with urinary tract tape exposure (59.4%). In patients who had SUI prior to sling excision (43.8%), the rate of resolved or improved SUI postoperatively was higher in the concomitant AFPVS group than in those who underwent sling excision alone (83.3% vs 12.5%, respectively; P = 0.03). Of 18 patients with no SUI prior to sling excision, 12 experienced recurrent SUI after sling removal (66.7%). The rate of recurrent SUI was lower in patients with vaginal MUS exposure than urinary tract MUS perforation, but this did not reach statistical significance (57.1% vs 72.7%, respectively; P = 0.63). The rates of resolved SUI after AFPVS were comparable in patients with concomitant and staged AFPVS (66.7% vs 71.4%, respectively; P = 0.99). CONCLUSIONS:Many patients with MUS perforations or exposures will have SUI at initial presentation or develop SUI after removal of the synthetic sling. The decision to perform a concomitant AFPVS or to stage the surgical management of SUI can be individualized.
PMID: 30900401
ISSN: 1757-5672
CID: 3735312

Trends In Stress Urinary Incontinence Surgery at a Tertiary Center: Midurethral Sling Use Following The AUGS/SUFU Position Statement

Palmerola, Ricardo; Peyronnet, Benoit; Rebolos, Mark; Khan, Aqsa; Sussman, Rachael D; Escobar, Christina; Smith, Shannon; Rosenblum, Nirit; Nitti, Victor W
OBJECTIVES/OBJECTIVE:To investigate trends in stress urinary incontinence (SUI) surgery before and after the 2011 FDA notification and the 2014 AUGS/SUFU position statement. METHODS:A retrospective chart review was performed to identify patients presenting for evaluation of SUI by two Female Pelvic Medicine and Reconstructive Surgery (FPMRS) specialists between June 1, 2010 and May 31, 2017. Rates of surgical treatment modality (synthetic midurethral slings (MUS) vs. autologous fascial pubovaginal sling (AFPVS) vs. bulking agents) were analyzed at 6 month intervals. RESULTS:Over 14 six-month intervals, the number of new patients presenting for evaluation of SUI increased consistently. There was a decrease in the proportion of new patients who underwent anti-incontinence surgical procedures, specifically MUS, between December 2011 and December 2013. After the integration of the 2014 AUGS/SUFU position statement in patient counseling, this trend reverted and we noted a sustained increase in the proportion of patients electing surgical management. This paralleled an increase in new patient visits for SUI and MUS. The number AFPVS remained stable throughout the study period. Conversely, MUS composed the highest proportion of procedures performed, accounting for 60 % to 87.2% off all anti-incontinence procedures. CONCLUSION/CONCLUSIONS:After the FDA Public Health Notification in 2011, we observed a decline in the number of new patients presenting with SUI electing surgical management, specifically MUS. However, after the AUGS/SUFU position statement publication and integration into counseling, we observed a reversal in the previous year's trends, noting a resurgence of MUS utilization.
PMID: 31229514
ISSN: 1527-9995
CID: 3954872