Refractory Urgency Urinary Incontinence Research Articles

Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial.

To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy. A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications. Both participants and providers were blinded to medication treatment allocation. Participants were randomized (1:1) to PTNS plus mirabegron or PTNS plus placebo. Participants completed a 3-day bladder diary prior to and after 12-week treatment. Validated symptom distress and impact questionnaires were obtained pre- and post-treatment. The primary outcome was change in mean number of UUIEs on a 3-day bladder diary pre- versus post-treatment between arms. Primary and secondary outcomes were analyzed via sample t tests. Fifty-four subjects were randomized, mean ± SD baseline age 56.2±15.6 years and body mass index 35.0±9.4 (kg/m2); no differences were noted in any clinical-demographic characteristics. There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). Significant differences were found pre- compared with post-treatment in urinary frequency, Overactive Bladder Questionnaire Short Form Symptom Bother and Symptom Health-Related Quality of Life scores. In subjects undergoing PTNS treatment for refractory UUI and OAB-wet symptoms, the addition of a β-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo.

Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence

ObjectiveTo evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence in patients with overactive bladder.The one-year pivotal study was extended through two years. The ITNS is a novel and recently FDA-approved therapy. MethodsA prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory urgency urinary incontinence to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the overactive bladder questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of urgency urinary incontinence episodes. The primary safety measure was device-related adverse events. Results72 subjects completed the 96-week evaluation. 78% (95% CI: 67% - 87%) experienced at least 50% reduction in urgency urinary incontinence episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their urgency urinary incontinence episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. 91.3% did not require additional medications for overactive bladder. No serious or unanticipated adverse events were reported in this extension phase. ConclusionsThe eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating overactive bladder patients with urgency urinary incontinence. The findings support it as an excellent treatment option for refractory patients.

Flat Magnetic Stimulation for Urge Urinary Incontinence.

Background and Objectives: Strategies for overactive bladder syndrome (OAB) management involve, among others, strengthening the bladder outlet to suppress urgency and neuromodulating the sacral roots. Magnetic stimulation (MS) is a technology that involves an extracorporeal device that is able to provide an electromagnetic field specifically designed to interact with pelvic floor neuromuscular tissue. The resulting tissue electrical activity induces contraction of the pelvic muscle and neuromodulation of the S2-S4 sacral roots. Flat Magnetic Stimulation (FMS) is a relevant advancement involving homogeneous electromagnetic fields, which are able to optimize the effect on the entire pelvic area. However, the benefits of this new technology for OAB syndrome are poorly known. Consequently, the aim of our study is to analyze the outcomes and quality of life (QoL) impact of FMS with Dr. Arnold (DEKA, Calenzano, Italy) in women suffering from OAB syndrome associated with urinary incontinence. Materials and Methods: This prospective study included patients with OAB, urge urinary incontinence, and no ongoing OAB treatments. At baseline (T0), the Incontinence Impact Questionnaire (IIQ-7), the Female Sexual Function Index (FSFI-19), and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) were collected. Patients underwent 8 FMS sessions of 25 min each in one month. At the termination of the therapy (T1), women repeated the ICIQ-UI SF, FSFI-19, and IIQ-7 tools. Moreover, the Patient Global Impression of Improvement (PGI-I) questionnaire was collected to evaluate the cure rate. Results: Our study enrolled a total of 57 consecutive patients. Most women had at least one second- or third-line treatment before FMS, while the remaining naive patients had contraindications to pharmacological treatments. No women reported adverse effects during the treatment. After the treatment, we observed a decrease in the IIQ-7 (p < 0.001) and ICIQ-UI SF scores (p < 0.001) and an improvement in sexual function (p < 0.001) evaluated with FSFI-19. According to PGI-I scores, 42 (73.7%) women referred to some kind of improvement, scoring ≤ 3 points. Specifically, 8.7% of patients considered themselves very much improved, 29.8% much improved, 35.1% minimally improved, and 26.3% found no changes. FMS was effective in treating OAB symptoms without any adverse effects. The mechanism is supposed to be related to suppressing the initiation of micturition. This makes FMS a promising device for treating naive and refractory urge urinary incontinence. Conclusions: The new FMS represents a promising non-pharmacological option for the treatment of naive and refractory OAB.

Long-term results of clam enterocystoplasty in non-neurogenic refractory urge incontinence.

This study aims to assess the efficacy of Clam enterocystoplasty (CECP) surgery for the treatment of non-neurogenic refractory urgency urinary incontinence (UUI). We conducted a retrospective evaluation of 17 female patients who underwent CECP for non-neurogenic refractory UUI between May 2010 and November 2022. The median of ICIQ-SF was 19 (15-21) before treatment, which decreased to a median of 0 (0-5) after treatment (p = 0.01). The average preoperative pad use among the participants was 4 (3-6), while it became 0 postoperatively (p < 0.01). The median preoperative cystometric bladder capacity was 251 ml (100-350 ml), increasing to 456 ml (400-650 ml) postoperatively (p < 0.01). According to the Clavien-Dindo classification system, the majority of patients experienced either no complications (66%) or minor complications (CD I/CD II) (33%) within the initial 90 days following surgery. "Clam" iliocystoplasty emerges as a secure and successful treatment option in the patient group whose symptoms persist after first, second, and third-line treatments with the diagnosis of urge incontinence.

Effect of Neuro-Adaptive Electrostimulation Therapy versus Sham for Refractory Urge Urinary Incontinence Due to Overactive Bladder: A Randomized Single-Blinded Trial.

This randomized clinical trial evaluates the success rate of neuro-adaptive therapy (NAT), applied with a specific neuro-adaptive regulator device, the Self-Controlled Electro Neuro-Adaptive Regulation (SCENAR), versus a sham for urge incontinence due to an overactive bladder (OAB). From February 2019 to May 2021, 66 patients were recruited. All subjects were randomized 1:1 at the first intervention visit to the NAT or sham procedure. Inclusion criteria were females between 18 and 80 years old with leakages due to an overactive bladder with unresponsiveness to medical therapy. Subjects were scheduled to receive up to eight weekly 20 min intervention sessions to obtain a complete (CR) or partial response (PR). Patients with no response after three sessions were considered as a failure. The primary end point of this trial was to assess the efficacy of NAT compared to an inactive sham intervention, evaluated 1 month after the last session. Analysis showed 23 (70%) patients responded (20 complete and 3 partial response) in the NAT group compared to 16 (48%) patients (all complete response) in the placebo arm (p = 0.014). Significant differences were maintained after the intervention, with persistent response at 3 months in 19 (58%) patients after active treatment and 14 (42%) after the placebo (p < 0.001), and at 6 months in 18 (55%) vs. 11 (33%) (p = 0.022), respectively. The number of sessions to achieve CR was similar in both arms, with 4.3 ± 1.9 in NAT and 3.9 ± 1.8 in the sham group (NS). Significant differences were observed between both groups for patients' satisfaction (p = 0.01). The binary model selected age as a predictor of response at the last follow-up. The odds ratio indicates that each year of increase in age, the probability of a positive response to treatment at 6 months decreases 0.95 (95% CI 0.9-0.99) times (p = 0.03). In conclusion, this pilot randomized trial gives evidence that neuro-adaptive electrostimulation is effective to treat refractory urge urinary incontinence due to OAB. The security and long-term efficacy of this treatment merits further evaluation. Moreover, its favorable profile and the economic advantages of the device make the evaluation of this promising technique mandatory in a primary therapeutic scenario.

Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence.

ObjectiveThe eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation.MethodsThis was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline.ResultsParticipants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%–90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%–95%) of participants were considered responders with 36% (95% CI, 20%–57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study.ConclusionsThe reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

Feasibility, Safety and Efficacy of Fractional Micro-Ablative CO2 Vaginal (FxCO2) Laser Treatment and Platelet-Rich Plasma (PRP) in Women with Urge Urinary Incontinence

Background: Urge urinary incontinence (UUI) is the involuntary loss of urine associated with urgency, frequency, and nocturia. Current management involves behavioural therapies, which can be time-consuming and costly to the patient, and medications, which can have side effects. Fractional micro-ablative CO2 laser (FxCO2) and platelet-rich plasma (PRP) are two novel approaches that may offer symptomatic relief for women with UUI. Objectives: To evaluate the feasibility, safety, and efficacy of FxCO2 vaginal laser treatment and PRP in women with refractory UUI with urinary function and sexual function as secondary outcome measures. Study Design: This was a single-centre prospective cohort study. Participants with UUI underwent three treatments of transvaginal FxCO2 laser and PRP, administered at 4–6-week intervals. Outcomes were assessed with the Australian Pelvic Floor Questionnaire (APFQ) at baseline (T1), 3-6 months (T2), and ≥12 months follow-up (T3). The 12-month follow up data were obtained by face-to-face visit or follow up telephone call. The primary outcome was change in UUI symptoms. Secondary outcomes were related to overall bladder function and sexual function. Outcomes were assessed using Wilcoxon signed-rank test. Results: In this study, 121 participants underwent treatment with FxCO2 laser and PRP for UUI. There was a significant reduction in the average severity of all self-reported measures of primary and secondary outcomes from T1 to T2 (p&lt;0.02). Improvements in all bladder function outcomes remained statistically at T3 (p&lt;0.04). There were no adverse events in this cohort. Conclusion: This study suggests that FxCO2 laser with PRP appears to be a safe, feasible, and effective treatment for UUI, bladder function, and sexual function. FxCO2 laser and PRP may have a role as an alternative therapy for severe and refractory UUI.

PD06-09 PATIENT EXPERIENCE WITH A LEADLESS TIBIAL NERVE STIMULATOR FOR URGENCY URINARY INCONTINENCE

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (PD06)1 Sep 2021PD06-09 PATIENT EXPERIENCE WITH A LEADLESS TIBIAL NERVE STIMULATOR FOR URGENCY URINARY INCONTINENCE Alexandra Rogers, Rebecca McCrery, James Lukban, Scott MacDiarmid, Subhro Sen, James Lukban, Bilal Kaaki, Andrew Shapiro, Thomas Guidice, John Nguyen, Joseph Gauta, Scott Serels, Chris Threatt, Jed Kaminetsky, Vincent Lucente, Sonia Dutta, Peter Sand, and Kimberly Ferrante Alexandra RogersAlexandra Rogers More articles by this author , Rebecca McCreryRebecca McCrery More articles by this author , James LukbanJames Lukban More articles by this author , Scott MacDiarmidScott MacDiarmid More articles by this author , Subhro SenSubhro Sen More articles by this author , James LukbanJames Lukban More articles by this author , Bilal KaakiBilal Kaaki More articles by this author , Andrew ShapiroAndrew Shapiro More articles by this author , Thomas GuidiceThomas Guidice More articles by this author , John NguyenJohn Nguyen More articles by this author , Joseph GautaJoseph Gauta More articles by this author , Scott SerelsScott Serels More articles by this author , Chris ThreattChris Threatt More articles by this author , Jed KaminetskyJed Kaminetsky More articles by this author , Vincent LucenteVincent Lucente More articles by this author , Sonia DuttaSonia Dutta More articles by this author , Peter SandPeter Sand More articles by this author , and Kimberly FerranteKimberly Ferrante More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001974.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Third line therapies for refractory overactive bladder (OAB) undertreat patients with only 5% of patients progressing to these invasive and/or burdensome therapies (Du et al.).A novel leadless, fully-implantable tibial nerve stimulator has unique attributes compared to current OAB treatments including automated compliance, a brief procedure using only local anesthetic and reliance on minimal resources. Patient experience with this device (eCoin®) was evaluated after 48 weeks of therapy. METHODS: A prospective, multi-center, single-arm trial was conducted to evaluate the eCoin in treatment of refractory urgency urinary incontinence (UUI). The device is slightly larger than a United States nickel and is implanted subcutaneously in the medial lower leg during an office procedure under local anesthetic, and once activated delivers automated 30-minute therapy sessions every 3-4 days. After 48 weeks of therapy, subjects were queried in a survey about their satisfaction and experience with the device and procedure and their attitudes about the study device as it compares to other therapies. RESULTS: Of the 132 subjects in the intent-to-treat population, 98% were female, mean (SD) age was 63.9 (10.9), and mean (SD) baseline UUI daily episodes was 4.3 (3.1). The primary efficacy analysis showed 68% (95% CI: 60%, 76%) of subjects experienced at least a 50% reduction in UUI episodes at 48 weeks. Patient experience is in line with efficacy results. 89% indicated they would recommend eCoin to friends and family with overactive bladder, and 93% indicated the procedure was easy enough to go through every five years. When directly compared to other OAB treatments, patients chose eCoin over OAB medications (84%), percutaneous tibial nerve stimulation (80%), onabotulinumtoxinA (74%), and sacral neuromodulation (82%). See the figure for response proportions. CONCLUSIONS: The data shows this maintenance-free device with a brief and minimally invasive implantation is well tolerated by patients. Compared to sacral neuromodulation (SNM), in which a recent study on the human experience with SNM surgery demonstrated 50% of subjects post IPG placement would not recommend the surgery to friend/family, eCoin may more effectively penetrate as a third line therapy for refractory UUI (Cohen et. al). Source of Funding: Valencia Technologies © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e103-e103 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alexandra Rogers More articles by this author Rebecca McCrery More articles by this author James Lukban More articles by this author Scott MacDiarmid More articles by this author Subhro Sen More articles by this author James Lukban More articles by this author Bilal Kaaki More articles by this author Andrew Shapiro More articles by this author Thomas Guidice More articles by this author John Nguyen More articles by this author Joseph Gauta More articles by this author Scott Serels More articles by this author Chris Threatt More articles by this author Jed Kaminetsky More articles by this author Vincent Lucente More articles by this author Sonia Dutta More articles by this author Peter Sand More articles by this author Kimberly Ferrante More articles by this author Expand All Advertisement Loading ...

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study

To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

The Safety and Efficacy of Sacral Neuromodulation on Refractory Urgency Urinary and Fecal Incontinence in Iraqi Patients

Background: Urinary urgency incontinence is characterized by symptoms of involuntary loss of urine thatpreceded or accompanied by sudden desire to void. Fecal incontinence is defined as involuntary passage ofstool through the anus. It may vary from soiling to complete evacuation. This involuntary loss of feces, flatusor urge incontinence adversely affects quality of life.Objectives: To evaluate the efficacy and safety of sacral neuromodulation on these pathologies.Method: Following a detailed investigation, 21 patients with either urinary incontinence, or both urinaryand fecal, who did not respond to medical and behavioral treatment were offered the sacral neuromodulationtherapy and followed for at least 12 months post implant regarding response and development of complicationif any found.Results: In the period from November 2015 to May 2017. The unit of neurogenic bladder and neuromodulationin surgical subspecialty hospital, medical city complex had implanted 21 Patients with urinary incontinencewere using from (4-17) pads/day (mean of 10.5/day) presacral neuromodulation which were declinedsignificantly to (0-3) pads/day (mean of 2.2/day).From the eighteen patients who presented with fecal incontinence after the implantation of sacralneuromodulation interstim 11 permanent devices only four remained incontinent .and from the nine patientswho presented with erectile dysfunction only two remained impotent.Conclusion: The use of Sacral Neuromodulation in Iraqi patients with Urinary and Fecal Incontinence issafe and effective

The evolution of incontinence into resolved, refractory and de novo urgency urinary incontinence following sling placement at time of prolapse repair in a large urodynamic cohort.

PurposeTo improve counseling in women at risk of refractory and/or de novo urgency urinary incontinence (UUI) following sling placement at time of prolapse repair, we created an outcome model to characterize changes in storage dysfunction.Materials and MethodsWe identified 139 women who underwent urodynamics followed by sling or no sling placement at the time of prolapse repair over a 6-year period. Our primary outcome was the presence of UUI following sling placement. Data were analyzed in SAS using chi-square, Fisher's exact, Student's t-test, and Kaplan-Meier methods.ResultsAt baseline, the sling group had significantly higher subjective (62/81 [76.5%] vs. 18/58 [31.0%]; p<0.001), objective (62/81 [76.5%] vs. 6/58 [10.3%]; p<0.001), and occult (41/81 [50.6%] vs. 6/58 [10.3%]; p<0.001) stress urinary incontinence (SUI); and rates of subjective and objective UUI were similar to the no sling group prior to surgery. After surgery (mean follow-up 859 days) there was no difference with or without sling, in the rate of SUI (subjective, objective) and further SUI treatments (bulking agent, repeat sling). Higher rates of de novo (13/81 [16.0%] vs. 6/58 [10.3%]; p=0.454) and refractory (31/81 [38.3%] vs. 14/58 [24.1%]; p=0.048) UUI were noted in the sling group following surgery. On Kaplan-Meier analysis, a greater proportion of women in the no sling group did not report UUI at longest follow-up (hazard ratio 0.63; 95% confidence interval 0.37–1.06; p=0.081).ConclusionsWomen should be counseled on the risk of de novo and refractory UUI following sling placement at time of prolapse repair.

526 - Surgical treatment of refractory urgency urinary incontinence in females with pelvic organ prolapse: A prospective randomized study in a tertiary care center

526 - Surgical treatment of refractory urgency urinary incontinence in females with pelvic organ prolapse: A prospective randomized study in a tertiary care center

PD06-09 THE POSTOPERATIVE PHENOTYPE OF RESOLVED, REFRACTORY AND DE-NOVO URGENCY URINARY INCONTINENCE FOLLOWING SLING PLACEMENT AT TIME OF PELVIC ORGAN PROLAPSE REPAIR WITH A MEDIAN FOLLOW-UP OF 1 YEAR

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Incontinence: Evaluation (Urodynamic Testing) (PD06)1 Apr 2020PD06-09 THE POSTOPERATIVE PHENOTYPE OF RESOLVED, REFRACTORY AND DE-NOVO URGENCY URINARY INCONTINENCE FOLLOWING SLING PLACEMENT AT TIME OF PELVIC ORGAN PROLAPSE REPAIR WITH A MEDIAN FOLLOW-UP OF 1 YEAR Xinyuan Zhang*, Robyn K. Shaffer, and Amy D. Dobberfuhl Xinyuan Zhang*Xinyuan Zhang* More articles by this author , Robyn K. ShafferRobyn K. Shaffer More articles by this author , and Amy D. DobberfuhlAmy D. Dobberfuhl More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000833.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To improve counseling in women at risk of refractory and/or de-novo urgency urinary incontinence following sling placement at time of prolapse repair, we created a two-by-two subjective outcome model to characterize changes in storage dysfunction following surgery. METHODS: We identified 139 women who underwent urodynamics (UDS) followed by prolapse repair with or without sling placement. Inclusion criteria included POP-Q stage 2+ cystocele and at least 7 days of follow-up. Our primary outcome was the presence of refractory and/or de-novo urgency urinary incontinence (UUI) following surgery. Data were analyzed using t-test, Chi-square and Fisher’s exact test. RESULTS: 139 women (age 62.6 ± SD 11.4 years old, BMI 27.0 ± SD 5.34) had pre-operative UDS which revealed a mean: [email protected] 20.5 ± SD 13.7 cmH2O, Qmax 17.7 ± SD 10.0 mL/s, capacity 528.7 ± SD 218.2 mL, PVR 117.1 ± SD 182.3 mL. Women underwent anterior only (n=64), apical only (n=19) or anterior/apical (n=56) prolapse repair for overall POP-Q stage 2 (n=55), 3 (n=77) or 4 (n=7) prolapse. A majority underwent sling placement (n=82; [email protected] 17.5 ± SD 11.0 cmH2O, Qmax 19.3 ± SD 10.0 mL/s, capacity 531.3 ± SD 221.3, PVR 88.2 ± SD 163.4 mL), versus the remaining who did not undergo sling placement [n=57; [email protected] 24.9 ± SD 16.0 cmH2O (p = 0.002), Qmax 15.3 ± SD 9.6 mL/s (p = 0.018), capacity 525.1 ± SD 215.7 mL (p = 0.870), PVR 158.7 ± SD 200.7 mL (p = 0.018)]. Following surgery (median 369 days), sling failure, defined as recurrence of objective stress urinary incontinence symptoms, at 3, 6, 12 were 8%, 10%, and 13% respectively. In those women who underwent sling placement, following surgery they developed de-novo (13/82, 15.9%), resolved (15/82, 18.3%), and refractory (31/82, 37.8%) UUI at a similar rate compared to those women who did not undergo sling placement [de-novo (6/57, 10.5%, p=0.293), resolved (15/57, 26.3%, p=0.232), and refractory (14/57, 24.6%, p=0.067) UUI]. CONCLUSIONS: Rates of de-novo, resolved and refractory urgency urinary incontinence following prolapse repair did not differ regardless of concurrent sling placement at time of prolapse surgery. Source of Funding: NIH 1L30DK115056-01 © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e157-e157 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Xinyuan Zhang* More articles by this author Robyn K. Shaffer More articles by this author Amy D. Dobberfuhl More articles by this author Expand All Advertisement PDF downloadLoading ...

82: Effectiveness of reduced site injection protocol of intra-detrusor onabotulinumtoxin A

To examine the effectiveness and patient satisfaction associated with the use of a 5-site intra-detrusor injection protocol of onabotulinumtoxin A among women with urgency urinary incontinence. We performed a prospective cohort study of women undergoing intra-detrusor injection of onabotulinumtoxinA (Botox) for treatment of refractory urgency urinary incontinence (UUI) from 11/1/18 to 6/1/19. A 5-site injection protocol using 100 units (U) Botox was performed as opposed to the standard 10-20 injection site protocol. Women were included if they underwent the 5-site injection protocol and completed pre-treatment (baseline), 2-week post-treatment, and 3-month post-treatment voiding diaries and questionnaires. Demographic data, rates of post-procedure voiding dysfunction and urinary tract infection were collected. Three-day voiding diaries were collected at baseline, 2 weeks and 3 months post-procedure. The primary outcome was number of UUI episodes/day at 3 months. Each set of questionnaires consisted of the Incontinence Impact Questionnaire short version (IIQ-7) and Urogenital Distress Inventory short form (UDI-6) at baseline, 2 weeks post-procedure and 3 months post-procedure, as well as the Patient Global Impression of Improvement (PGI-I) at 2 weeks and 3 months. We compared baseline UUI episodes/day and questionnaire scores with matching parameters at 3 months using the Wilcoxon rank-sum test. A total of 19 women met inclusion criteria during the study period. The median age was 68 years [interquartile range, IQR 57-72], median BMI was 33 kg/m2 [IQR 28.3-36]. Sixteen (84.2%) patients identified as white, while 2 (10.5%) were black. Sixteen patients (84.2%) were menopausal, and 6 (31.6%) were diabetic. There was a statistically significant decrease in the median number of UUI episodes per day from baseline (median 4 [IQR 3-10.5]) to 3 months post-procedure (median 1 [IQR 0-2], p=0.007). There was also a statistically significant improvement in IIQ-7 scores from baseline (median 9 [IQR 7-15]) to 3 months post-procedure (median 3 [IQR 1-9], p=0.001). There was no difference in UDI-6 scores from baseline (median 7 [IQR 5-10]) to 3 months (median 5 [IQR 2-8], p=0.307). Five patients (26.3%) had post-procedure voiding dysfunction, while 2 (10.5%) had a post-procedure urinary tract infection. Fifteen patients (79%) reported symptoms were at least a little better based on the PGI-I at 2 weeks and at 3 months. A 5-site injection protocol of intradetrusor Botox resulted in statistically significant improvements in UUI episodes/day and quality of life at 3 months compared to baseline. These findings suggest that 5 injections are comparable to 10-20 in terms of published outcomes and complications.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function

Women with refractory urgency urinary incontinence can be treated with onabotulinumtoxinA or sacral neuromodulation. Little data exists on the comparative effects of treatment of refractory urgency urinary incontinence on other pelvic floor complaints, such as bowel and sexual function. The objective of this study was to compare the impact of these treatments on fecal incontinence and sexual symptoms. This was a planned supplemental analysis of a randomized trial in women with refractory urgency urinary incontinence treated with onabotulinumtoxinA (n= 190) or sacral neuromodulation (n= 174). Fecal incontinence and sexual symptoms were assessed at baseline and at 6, 12, and 24 months. Fecal incontinence symptoms were measured using the St Mark's (Vaizey) Fecal Incontinence severity scale. Sexual symptoms were measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The PISQ-IR allows measurement of sexual symptoms in both sexually active and non-sexually active adults. Primary outcomes were change in Vaizey and PISQ-12 scores between baseline and 6 months. Secondary outcomes were change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12, and PISQ-IR scores between baseline and 12 and 24 months. Intent-to-treat analysis was performed using repeated measures mixed model to estimate change in all parameters from baseline while adjusting for the baseline score. A subgroup analysis of women with clinically significant bowel symptoms was conducted based on baseline Vaizey score of ≥12. At baseline, mean Vaizey scores were indicative of mild fecal incontinence symptoms and were not different between onabotulinumtoxinA and sacral neuromodulation groups (7.6 ± 5.3 vs 6.6 ± 4.9, P= .07). The proportion of sexually active women (56% vs 63%, P= .25), mean PISQ-12 score (33.4 ± 7.5 vs 32.7 ± 6.7, P= .55), or PISQ-IR subscores were also not different between the onabotulinumtoxinA and sacral neuromodulation groups at baseline. There was no difference between women treated with onabotulinumtoxinA and those treated with sacral neuromodulation at 6 months in terms of improvement in fecal incontinence symptom score (Vaizey: -1.9, 95% confidence interval -2.6 to -1.2 vs -0.9, 95% confidence interval -1.7 to -0.2, P= .07) or sexual symptoms score (PISQ-12: 2.2, 95% confidence interval 0.7 to 3.7 vs 2.2, 95% confidence interval 0.7 to 3.7, P= .99). There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months. Similar findings were noted at 12 and 24 months. In a subgroup (onabotulinumtoxinA= 33 and sacral neuromodulation= 22) with clinically significant fecal incontinence at baseline (Vaizey score ≥12), there was a clinically meaningful improvement in symptoms in both groups from baseline to 6 months, with no difference in improvement between the onabotulinumtoxinA and sacral neuromodulation groups (-5.1, 95% confidence interval -7.3 to -2.8 vs -5.6, 95% confidence interval -8.5 to -2.6, P= .8). There were no differences in improvement of fecal incontinence and sexual symptoms in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation. Women with significant fecal incontinence symptoms at baseline had clinically important improvement in symptoms, with no difference between the treatments. Our findings can help clinicians counseling women considering treatment for refractory urgency urinary incontinence.

73: Impact of refractory urgency urinary incontinence treatment on bowel and sexual function

73: Impact of refractory urgency urinary incontinence treatment on bowel and sexual function

Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence

BackgroundWe conducted a clinical feasibility trial to evaluate the safety and efficacy of a fully-implanted, primary battery-powered, nickel-sized and shaped neuromodulation device called the eCoinTM (Valencia Technologies Corp., Valencia, CA, USA) for tibial nerve stimulation to treat refractory urgency urinary incontinence. MethodsThis was a prospective, single-arm, open-label study including 46 participants with refractory UUI, conducted at multiple sites in the US and New Zealand. The eCoinTM was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3 and 6 months post-activation, were compared to baseline. ResultsMean age was 63.4 ± 11.5 years and 45 (98%) participants were female. Episodes of urgency urinary incontinence were reduced by a median 71% after 3 months of treatment (4.2 versus 1.7 daily episodes at 3 months; P=.001). A ≥50% reduction in reported episodes of urgency urinary incontinence was observed in 32/46 participants (69.6%) at 3 months with more than 20% of participants dry at 3 and at 6 months. Incontinence quality of life (I-QOL) scores improved by an average of 25.9 points, and 33/46 patients (72%) indicated improvement in symptoms. A single serious adverse event, secondary to wound care, resolved with intravenous antibiotics. ConclusionsThe implantable neuromodulation device was a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or resolution of symptoms and no significant safety concerns.

Does Urodynamics Impact the Outcomes of Third-line Therapy of Refractory OAB (or Refractory Urgency Urinary Incontinence)?

Overactive bladder (OAB) is highly prevalent with increasing age. Conservative management including lifestyle adaptation, controlled fluid intake, and bladder training are considered first-line therapeutic options. Second-line options are medication such as antimuscarinics or beta-3 adrenergic receptor agonists. Therapy refractory patients should be referred to a specialist for further evaluation. It currently remains unclear if patients should undergo routine urodynamic investigation (UDI) before offering third-line therapies like sacral neuromodulation (SNM) or intradetrusor injection of onabotulinumtoxinA (IdetInBotA). The aim of this narrative review was to assess if the presence of detrusor overactivity (DO) can predict treatment success of third-line therapies for OAB. There is only limited evidence available for both IdetInBotA and SNM, but treatment success does not appear to be related to the presence of DO in baseline UDI. Hence, routine UDI is not mandatory in patients with OAB but remains an option when its outcome is likely to change the treatment strategy or to assess the risk of upper urinary tract deterioration.

Characteristics Associated With Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence

(Abstracted from J Urol 2017;198:890–896) Primary treatment approaches for women with urgency urinary incontinence (UUI) include medications and behavioral therapy. Patients with UUI refractory to primary treatments may be offered third-line treatment options such as sacral neuromodulation (SNM) or onabotulinumtoxinA.