Intravesical BoNT-A Research Articles

Effects of onabotulinum toxin-A injection on sexual function in women with refractory interstitial cystitis/bladder pain syndrome: A prospective study.

To determine the effect of intravesical onabotulinum toxin-A (BoNT-A) treatment on sexual functions in female patients with refractory interstitial cystitis/bladder pain syndrome (IC/BPS). Female patients with IC/BPS refractory to previous treatments were included in the study between January 2020 and April 2022. Patients were treated with the trigone-sparing injection (Group 1) or trigone-included injection (Group 2) techniques. 100 Units of BoNT-A was applied submucosally on 20 different points. The patients were evaluated with visual analog scale (VAS), O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI), Interstitial Cystitis Problem Index (ICPI), Female Sexual Function Index (FSFI) questionnaires, 3-day voiding diary, uroflowmetry, and post-voiding residual volume analysis in the preoperative period, as well as on the 30th and 90th days postoperatively. For the repeated measurements, analysis of variance was used to assess the time-dependent variation across groups. The baseline FSFI score of the patients was 15.96 ± 3.82. Following the treatment, the FSFI scores were 22.43 ± 4.93 and 24.41 ± 5.94 on the 30th and 90th days, respectively (p < .001). We observed statistically significant improvement in all FSFI subdomains (p < .05). Statistically significant improvements with treatment on ICSI, ICPI, and VAS scores were achieved (p < .05). Preoperative FSFI scores were similar in Group 1 and Group 2 (p = .147). While the preoperative FSFI scores were 17.00 ± 3.73 and 14.84 ± 3.72 for Group 1 and Group 2, respectively, the scores after the treatment were 22.85 ± 5.01 and 21.98 ± 5.01 on the 30th day, and 24.62 ± 6.06 and 24.19 ± 6.05 on the 90th day postoperatively. Significant improvement was observed in FSFI scores with treatment, and no difference was observed between the two groups in terms of treatment response (p = .706). Intravesical BoNT-A injection in the treatment of women with refractory IC/BPS improves sexual functions. It also significantly improves pain and symptom scores. Both trigone-sparing and trigone-including injections are similarly safe and effective.

Impact of the suspension of neurogenic detrusor overactivity treatment with botulinum toxin due to the COVID-19 pandemic.

The COVID-19 pandemic has imposed an additional pressure on health systems worldwide. Patients with neurogenic detrusor overactivity (NDO) were especially vulnerable to inadequate care. This study aims to evaluate the impact of the suspension of NDO treatment with Botulinum Toxin (BONT-A) due to the COVID-19 pandemic. Cross-sectional study of patients with spinal cord injury and NDO, who underwent BONT-A treatment in 2018 or 2019 and, whose administration programed for 2020 or 2021 was suspended. The study protocol was divided into two parts. Phase 1 consisted of data collection from the clinical processes and in phase 2 a standardized telephone questionnaire was applied. Information was collected at 3 time points: (1) before the last BONT-A treatment, (2) after the last BONT-A treatment and (3) at the time of the telephone call. Statistical analysis used the McNemar and the Wilcoxon test with a p-value ⩽ 0.05 as level of significance. 21 patients with mean age of 42.0 years and disease duration of 16.9 years were included. On average patients were undergoing treatment with BONT-A for 7.6 years and mean inter-treatment frequency was 2.3 years. Mean time since the last BONT-A administration was 2.3 years and mean reported BONT-A effect duration was 11.9 months. A significant increase in the percentage of patients with involuntary urinary loss (p = 0.004) and urgency (p = 0.031) was found. A significant decrease in mean catheterization interval from 4.5 to 3.6 h (p = 0.002) and an increase in daily oxybutynin dosage from 8.5 to 12.1 mg (p = 0.002) was also found. The COVID-19 pandemic originated clinical worsening of patients undergoing regular BONT-A treatment for NDO. These patients presented a significant increase in involuntary urinary loss, urgency and medication dosage and a decrease in catheterization interval. Thus, interruption of intravesical BONT-A treatment severely affected these patients and needs to be avoided.

P0022 - 5-year continuation rate of intra-vesical BoNTA injections in multiple sclerosis patients with lower urinary tract dysfunction: A retrospective study from the French Committee of Neuro-Urology

P0022 - 5-year continuation rate of intra-vesical BoNTA injections in multiple sclerosis patients with lower urinary tract dysfunction: A retrospective study from the French Committee of Neuro-Urology

Factors predicting the success of intradetrusor onabotulinum toxin-A treatment in children with neurogenic bladders due to myelomeningocele: The outcomes of a large cohort

This study aimed to determine the effectiveness of intradetrusor injections of onabotulinum toxin-A (BoNT-A) in pediatric patients with neurogenic bladders (NB) due to myelomeningocele (MMC). The factors predicting success were also evaluated. We retrospectively identified 62 patients with NB due to MMC who underwent intravesical BoNT-A injection (100-300 U) between May 2013 and December 2018. Indications for BoNT-A injection were according to the European Association of Urology guidelines and included children for whom clean intermittent catheterization (CIC) and anticholinergic therapy had failed. Children who had previous bladder surgery or anti-reflux operations, coagulation disorders, myasthenia gravis, and non-neurogenic bladders were excluded. Twenty-one patients had accompanying vesicoureteral reflux (VUR). Preoperative and postoperative urodynamic parameters, clinical success, and VUR grades for all patients were recorded. Clinical success was defined as 4h of dryness or bladder control between CICs. Logistic regression analysis was performed to evaluate the factors affecting treatment success. The mean age of the children was 9±3.36 years. The mean follow-up was 28.5±12.2 months. Clinical success was achieved in 64.5% (n: 40) of the patients. The mean maximal cystometric capacity increased from 172.4±45.6mL to 236.3±67.2mL. The mean bladder compliance increased from 14.8±8.1mL/cm H2O to 19.3±7.4mL/cm H2O, and the mean maximal detrusor pressure decreased from 56.7±18.8cmH2O to 36.6±10.1cmH2O. Urodynamic parameters did not improve in patients with hypocompliant (fibrotic) bladders. In patients with accompanying VUR, reflux was completely resolved in 53.8% (n: 14) of the ureters, improved in 26.9% (n: 7) of the ureters, and remained unchanged in 19.2% (n: 5) of the ureters after subureteral injection. Intradetrusor BoNT-A injections provide excellent outcomes in children with NB refractory to conservative treatments. Poor responses were observed in patients who had low-compliant bladders without detrusor overactivity.

Long-term Follow-up of Intravesical Onabotulinum Toxin-A Injections in Male Patients with Idiopathic Overactive Bladder: Comparing Surgery-naïve Patients and Patients After Prostate Surgery

BackgroundEvidence regarding long-term results in male idiopathic overactive bladder (iOAB) patients is limited and rarely focuses on the effects of prior prostatic surgery. ObjectiveThis study aims to identify the long-term treatment persistency and occurrence of adverse events of intravesical onabotulinum toxin-A (BoNT-A) injections in male iOAB patients after prostatic surgery (ie, transurethral resection of the prostate [TURP] or radical prostatectomy [RP]) compared with surgery-naïve patients. Design, setting, and participantsIn this retrospective, single-centre study, data from 477 patients treated with intravesical BoNT-A injections were collected. Outcome measurements and statistical analysisOutcome data of 120 male patients with iOAB, with collectively 207 BoNT-A injections, were analysed and presented in this study. Results and limitationsAt the last point of follow-up, 35 patients (29.2%) were still on active treatment. Twenty patients (16.7%) required de novo clean intermittent self-catheterisation (CISC). Three groups were identified: 56 patients without prostate surgery, 40 patients with TURP, and 24 patients with RP prior to treatment. Discontinuation rates and patient-reported outcomes of BoNT-A treatment (none, insufficient, or satisfactory) were similar, but a significant difference was seen in de novo CISC (p=0.004): 28.6% in the group without prior surgery, 7.5% in the TURP subgroup, and 4.2% in the RP subgroup. Odds of de novo CISC was significantly higher for the group without prior surgery than for both the TURP subgroup (odds ratio [OR] 4.9; 95% confidence interval [CI]: 1.33–18.31; p=0.017) and the RP subgroup (OR 9.2; 95% CI: 1.14–73.96; p= 0.037). ConclusionsThe data of this retrospective, single-centre cohort suggest that BoNT-A treatment leads to lower CISC rates in male patients after prior desobstructive surgery than in surgery-naïve patients. Patient summaryThis study describes the results of onabotulinum toxin-A (BoNT-A) injections in the bladder of male patients with idiopathic overactive bladder after initial prostate surgery compared with surgery-naïve patients. The results showed that BoNT-A treatment leads to lower catheterisation rates in patients after prior prostate surgery than in men without prior prostate surgery.

Real-World Retention Rates After Intravesical OnabotulinumtoxinA for Idiopathic Overactive Bladder

(Abstracted from Female Pelvic Med Reconstr Surg 2018;24:404–407) Intravesical onabotulinumtoxinA (BoNT-A) is used for treatment of idiopathic overactive bladder (iOAB) when conservative measures and medications fail to improve symptoms. After intravesical BoNT-A, the risk of incomplete bladder evacuation (IBE) requiring catheterization is well established.

Novel Applications of OnabotulinumtoxinA in Lower Urinary Tract Dysfunction.

OnabotulinumtoxinA (BoNT-A) was first used to treat neurogenic lower urinary tract dysfunction (LUTD) 30 years ago. Recently, application of BoNT-A in LUTD have become more common since the approval of intravesical BoNT-A injection for patients with both overactive bladders (OAB) and neurogenic detrusor overactivity (NDO) by regulatory agencies in many countries. Although unlicensed, BoNT-A has been recommended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS) under different guidelines. BoNT-A delivery with liposome-encapsulation and gelation hydrogel intravesical instillation provided a potentially less invasive and more convenient form of application for patients with OAB or IC/BPS. BoNT-A injections into the urethral sphincter for spinal cord injury patients with detrusor-sphincter dyssynergia have been used for a long time. New evidence revealed that it could also be applied to patients with non-neurogenic dysfunctional voiding. Previous studies and meta-analyses suggest that BoNT-A injections for patients with benign prostate hyperplasia do not have a better therapeutic effect than placebo. However, new randomized and placebo-controlled trials revealed intraprostatic BoNT-A injection is superior to placebo in specific patients. A recent trial also showed intraprostatic BoNT-A injection could significantly reduce pain in patients with chronic prostatitis. Both careful selection of patients and prudent use of urodynamic evaluation results to confirm diagnoses are essential for successful outcomes of BoNT-A treatment for LUTD.

The use of urodynamic studies for the followup of neurogenic bladders treated with onabotulinumtoxinA

Intradetrusor injection of onabotulinumtoxinA (BoNTA) is well-established as treatment for patients with neurogenic bladders. Urodynamics (UDS) is used at regular intervals during followup to monitor intravesical pressure. With regards to the discomfort and risks associated with UDS, our objective was to assess if UDS done at regular intervals in the followup of neurogenic bladders treated with BoNTA had an impact on management. We retrospectively analyzed the medical records of adult patients with neurological disorders treated with BoNTA for either detrusor overactivity or low bladder compliance at the Institut de Réadaptation en Déficience Physique de Québec (IRDPQ). At our centre, UDS was routinely performed at baseline, three months after the first treatment, then three months after every fifth set of injections. We identified 57 patients with neurological disorder treated with intravesical BoNTA. Each patient had between one and 19 sets of injections (mean 5.61 injections) and 1-6 followup UDS (mean 2.09). Of the 119 followup UDS reviewed at our centre, three UDS (2.5%) resulted in a modification of the urinary tract management from BoNTA to bladder augmentation. Two regimens were suspended and one was ended due to patient preference. Our study showed that UDS at pre-set intervals for followup of patients receiving BoNTA injections were rarely associated with modifications in the treatment course. Therefore, UDS should only be performed in cases where there are changes in the patient's symptoms or if the urologist suspects that the treatment response is suboptimal.

Long-term follow-up of intravesical botulinum toxin-A injections in women with idiopathic overactive bladder symptoms.

Intravesical botulinum toxin (BoNT-A) is a safe and effective treatment for overactive bladder syndrome. There are many reports on the clinical experience with BoNT-A, especially in patients with neurogenic detrusor overactivity. The US Food and Drug Administration has recently approved its use for idiopathic overactive bladder (iOAB). Various studies have reported positive results for iOAB in the short-term. Yet little is known about the results after repeated BoNT-A injections. In this study, we evaluated the long-term results of botulinum toxin (BoNT-A) in women with iOAB. Patients treated with BoNT-A from 2004 until 2009 were evaluated in a non-academic teaching hospital (Zuyderland MC, Heerlen, the Netherlands). All female patients with a follow-up of >5years with idiopathic bladder dysfunction were included. All patients received 200U of onabotulinum toxin-A in 20 intradetrusor injections. In some patients, we applied a dose adjustment for repeated injections. Patients were instructed how to use clean intermittent self-catheterization (CISC) before the treatment. We advised patients to commence CISC if post-void residual exceeded 150ml. A total of 128 women were included. All patients had at least 5-year follow-up after their first injection. The mean follow-up was 97 (60-125) months. The mean age was 67 (46-88) years. Of all patients, 30% were still on BoNT-A treatment at the last follow-up visit. Of the 70% that discontinued treatment, 27% had insufficient effect and 43% had tolerability issues. Most patients discontinued treatment after the first (79%) and second (19%) injections. Only 2% of patients discontinued treatment after more than two injections during follow-up. Intravesical BoNT-A is an effective treatment for women with idiopathic OAB. However, in time, almost two-thirds of patients in our study discontinued therapy. Most patients discontinue treatment after one or two injections and mainly due to tolerability issues.

Intravesical OnabotulinumtoxinA Injection for Overactive Bladder Patients with Frailty, Medical Comorbidities or Prior Lower Urinary Tract Surgery.

Overactive bladder (OAB) symptoms increase with age and involve several comorbidities. OnabotulinumtoxinA (BoNT-A) intravesical injection is a treatment choice for patients who are intolerant of or refractory to antimuscarinics. However, the increased risk of urinary tract infection and elevated post-void residual (PVR) volume post-treatment require resolution. Male sex, baseline PVR > 100 mL, and comorbidities are independent risk factors of adverse events (AEs) such as acute urinary retention (AUR). Intravesical BoNT-A injection is safe and effective for OAB patients with frailty, medical comorbidities such as Parkinson’s disease (PD), chronic cerebrovascular accidents (CVA), dementia, or diabetes, or a history of prior lower urinary tract surgery (prostate or transvaginal sling surgery). Post-treatment, 60% of frail elderly patients had a PVR volume > 150 mL and 11% had AUR. Although intravesical BoNT-A injection is safe for PD patients, CVA patients had higher strain voiding rates. Diabetic patients were at increased risk of large PVR urine volume and general weakness post-treatment. Treatment results were similar between patients with and without a history of prostate or transvaginal sling surgery. Possible AEs and bladder management strategies should be conveyed to patients before treatment. Careful patient selection is important, and therapeutic safety and efficacy should be carefully balanced.

Practical Aspects of Botulinum Toxin-A Treatment in Patients With Overactive Bladder Syndrome.

Intravesical onabotulinumtoxinA (BoNT-A) injection is an effective treatment for overactive bladder syndrome (OAB) that is refractory to antimuscarinics. An injectable dose of 100 U has been suggested to achieve the optimal balance of benefit and safety in patients with OAB. BoNT-A (total volume of 10 mL) was administered as evenly distributed intradetrusor injections (5 U) across 20 sites approximately 1 cm apart (0.5 mL per site) using a flexible or rigid cystoscope. Treatment with BoNT-A was generally well tolerated by most patients, and most treatment-related adverse events were localized to the urinary tract. The prevalence of OAB increases with age, and elderly patients are more vulnerable to complications. The short-term efficacy of intravesical BoNT-A injection for refractory OAB with no treatment-related complications in the elderly population has been documented. Frail elderly patients can experience the same treatment results, such as significantly improved urgent urinary incontinence and quality of life, as young and nonfrail elderly patients with 100-U BoNT-A injections. However, increased risk of larger postvoid residual (PVR) urine and lower long-term success rates were noted in frail elderly patients; around 11% had acute urinary retention, while 60% had PVR urine volume >150 mL after treatment. In addition, intravesical injection of BoNT-A effectively decreased urgency symptoms in elderly patients with OAB and central nervous system lesions. The adverse effects were acceptable, while the long-term effects were comparable to those in patients with OAB without central nervous system lesions. Nonetheless, the possibility of longstanding urinary retention and chronic catheterization in this vulnerable population requires careful evaluation before treatment with intravesical BoNT-A. In conclusion, the current findings indicate that intravesical BoNT-A is an effective and safe treatment for OAB in elderly patients.

Long-Term Efficacy and Safety of Repeated Intravescial OnabotulinumtoxinA Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome.

Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), but lacks sustainability. Repeated injections have been shown to provide a superior outcome to a single injection, but data on long-term efficacy and safety is limited. In this prospective study, we enrolled patients with refractory IC/BPS, and treated them with 100 U of BoNT-A injection plus hydrodistention followed by repeated injections every six months for up to two years or until the patient wished to discontinue. A “top-up” dose was offered after the fourth injection. Of these 104 participants, 56.7% completed four BoNT-A injections and 34% voluntarily received the fifth injection due to exacerbated IC symptoms. With a follow-up period of up to 79 months, O’Leary-Sant symptom and problem indexes (ICSI, ICPI, OSS), pain visual analogue scale (VAS) functional bladder capacity, frequency episodes, and global response assessment (GRA) all showed significant improvement (p < 0.0001). Those who received repeated injections had a better success rate during the long-term follow-up period. The incidence of adverse events did not rise with the increasing number of BoNT-A injections. A higher pre-treatment ICSI and ICPI score was predictive for successful response to repeated intravesical BoNT-A injections plus hydrodistention.

Predictive factors of adverse events after intravesical suburothelial onabotulinumtoxina injections for overactive bladder syndrome-A real-life practice of 290 cases in a single center.

Patients often experience adverse events (AEs) after intravesical onabotulinumtoxinA (BoNT-A) treatment for overactive bladder refractory to antimuscarinic agents. We investigated the prevalence and predictive factors of AEs in such patients. A total of 290 patients underwent intravesical BoNT-A (100 U) suburothelial injection. The age, gender, overactive bladder subtypes, medical co-morbidities, and neurological diseases of the patients were recorded. The maximum flow rate (Qmax ), voided volume, post-void residual (PVR) volume, and voiding efficiency (VE) at baseline were analyzed to identify adverse events within 3 months after treatment. Acute urinary retention (AUR) developed in 24 patients (8.3%), and urinary tract infection (UTI) occurred in 44 (15.2%) within 3 months of treatment. Large PVR volume (>200 ml) occurred in 81 (27.9%), 68 (24.3%), and 49 (18.4%) patients 1, 3, and 6 months after treatment, respectively. AUR developed significantly more often in men, patients >61 years old, those with a baseline Qmax ≤15 ml/sec, PVR ≥100 ml, and VE <90%. Patients older than 61 years had a higher incidence of large PVR 1 month after treatment. Female gender and a baseline PVR volume ≥100 ml had a greater incidence of UTI. Age >61 years, low Qmax , low voiding efficiency, and large PVR at baseline were also risk factors for adverse events. AUR, UTI, and large PVR volume are common AEs after BoNT-A treatment. Patients with overactive bladders that are at risk of developing AEs after BoNT-A injection should be informed of the possible AEs. Neurourol. Urodynam. 36:142-147, 2017. © 2015 Wiley Periodicals, Inc.

Intravesical botulinum toxin-A injections reduce bladder pain of interstitial cystitis/bladder pain syndrome refractory to conventional treatment - A prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial.

Intravesical onabotulinumtoxinA (BoNT-A) injection is a beneficial treatment for interstitial cystitis/bladder pain syndrome (IC/BPS), yet its therapeutic efficacy remains to be validated. This study tests efficacy and safety of intravesical BoNT-A injections for treatment of IC/BPS. A multicenter, randomized, double-blind, placebo-controlled trial in patients with IC/BPS refractory to conventional treatment. Patients were randomized in a 2:1 ratio to hydrodistention plus suburothelial injections of BoNT-A 100 U (Botox group) or the equivalent amount of normal saline (N/S group). The primary endpoint was a decrease in pain assessed using a visual analog scale (VAS) at week 8 after treatment. Secondary endpoints included voiding diary and urodynamic variables. The Wilcoxon sign rank and rank sum tests were used for statistical analyses. A total of 60 patients (8 males, 52 females, age 50.8 ± 13.9 years) including 40 in the Botox and 20 in the N/S groups were enrolled. At week 8, a significantly greater reduction of pain was observed in the Botox group compared to the N/S group (-2.6 ± 2.8 vs. -0.9 ± 2.2, P = 0.021). The other variables did not differ significantly between groups except for cystometric bladder capacity, which was increased significantly in the Botox group. The overall success rates were 63% (26/40) in the Botox group and 15% (3/20) in the N/S group (P = 0.028). Adverse events did not differ between the groups. Intravesical injections of 100 U of BoNT-A effectively reduced bladder pain symptoms in patients with IC/BPS. The adverse events were acceptable. Neurourol. Urodynam. 35:609-614, 2016. © 2015 Wiley Periodicals, Inc.

Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity.

To assess the efficacy and morbidity of alkalinized lidocaine solution compared to lidocaine gel for intra-vesical anesthesia during botulinum toxin (BoNTA) injections in a statistically powered, prospective, parallel group, double-blind randomized controlled trial. Fifty-four patients of either sex were randomized to receive either alkalinized lidocaine (AL) solution (10 ml 8.4% sodium bicarbonate + 20 ml 2% lidocaine solution + 22 ml sterile Aquagel®) or lidocaine gel (LG) (22 ml standard 2% lidocaine gel Instillagel® + 30 ml 0.9% normal saline solution). Primary outcome was average pain (assessed by 100 mm visual analog score) felt during intra-vesical BoNTA injections performed at least 20 min after instillation. Secondary outcome was the rate of adverse events. Of 60 randomized patients 54 received the allocated intervention and were analyzed. Mean pain score in the AL group was 17.11 mm (95%CI 8.65-25.57 mm) and in the LG group was 19.53 mm (95%CI 13.03-26.03mm) with no significant difference between the groups. Cost of interventional medication in the AL group was almost double that of the LG group. No adverse events were attributable to local anesthetic instillation in either group. Alkalinized lidocaine solution is not superior to lidocaine gel for anesthesia during intra-vesical BoNTA injections, and the higher cost precludes its use over lidocaine gel at our centre. We have used the results of this study to adapt our local protocol for BoNTA injections and continue to use lidocaine gel as the local anesthetic of choice. Neurourol. Urodynam. 35:522-527, 2016. © 2015 Wiley Periodicals, Inc.

Repeated intravesical onabotulinumtoxinA injections are effective in treatment of refractory interstitial cystitis/bladder pain syndrome

To evaluate the efficacy and safety of repeated intravesical onabotulinumtoxinA (BoNT-A) injections for treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). Patients confirmed to have IC/BPS and refractory to conventional treatments were treated with intravesical injections of 100 U of BoNT-A plus hydrodistention every 6 months for up to four times. Primary end-point was 6 months after the fourth BoNT-A injection. Measured parameters included O'Leary-Sant symptom score (OSS) including symptom and problem indexes (ICSI/ICPI), visual analogue score (VAS) for pain, voiding diary variables, urodynamic parameters, maximal bladder capacity (MBC), glomerulation grade, and global response assessment (GRA). Multiple measurements and Wilcoxon rank-sum test were used for comparison between groups. In overall patients, GRA, OSS, ICSI and ICPI scores, VAS, functional bladder capacity (FBC) and cystometric bladder capacity (CBC) all showed significant improvement. The glomerulation grade decreased (1.77 ± 1.06 vs. 1.19 ± 1.05, p = 0.026), but MBC remained unchanged. Among 31 patients, 19 (61%) had a GRA ≥ 2 and 12 (39%) had a GRA < 2 at end-point. Patients with a GRA ≥ 2 had significantly greater changes in OSS, ICPI, VAS, FBC and CBC than patients with a GRA < 2. Extended study revealed that persistent symptomatic improvement lasted 6-12 months in seven, 13-22 months in six and 23-51 months in six after the fourth BoNT-A injection. Five women who had GRA < 2 were found to have Hunner's ulcer. Lack of control is the main limitation. Four repeated intravesical BoNT-A injections were safe and effective for symptom and pain relief and increased bladder capacity for treatment of IC/BPS.

Intravesical OnabotulinumtoxinA Injections for Refractory Painful Bladder Syndrome

Background: Bladder pain associated with interstitial cystitis and painful bladder syndrome (IC/PBS) is frequently excruciating and intractable. The use of onabotulinumtoxinA (BoNT-A) for relief of this type of bladder pain has not been well described. Objectives: To evaluate the efficacy and safety of intravesical BoNT-A injection for treatment of IC/PBS refractory to conventional treatment. Study Design: Prospective, non-randomized study. Setting: A tertiary medical center in Taiwan. Methods: Sixty-seven patients with characteristic IC/PBS were enrolled. Intravesical injection of 100U of BoNT-A immediately followed by cystoscopic hydrodistention under intravenous general anesthesia. Changes of the urodynamic parameters, O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI), visual analog score (VAS) for pain, functional bladder capacity, and global response assessment (GRA) were evaluated at baseline and 6 months after BoNT-A injection. Adverse events that occurred after this procedure were also assessed. Results: Significant improvement was shown after intravesical injection of 100 U of BoNT-A. Baseline and 6 months after injection scores were: ICSI and ICPI (23.6 ± 5.9 versus 15.2 ± 8.5, P = 0.000), VAS (5.3 ± 2.2 versus 3.3 ± 2.4, P = 0.000), functional bladder capacity (136 ± 77.6 versus 180 ± 78.2, P = 0.000) and GRA (0.3 ± 0.8 versus 1.4 ± 1.0, P = 0.000). Limitations: This study lacks a placebo control group so the placebo effect cannot be eliminated. This study also does not provide information about the efficacy of this treatment after 6 months. Conclusion: Intravesical onabotulinumtoxinA injection appears to be a safe and effective therapeutic option for analgesia and increased bladder capacity for patients with IC/PBS. Institutional Review: This study was approved by the Institutional Review Board of the Buddhist Tzu-chi General Hospital. Key words: Botulinum toxin, interstitial cystitis/painful bladder syndrome, intravesical treatment, bladder pain

2314 BASELINE URODYNAMIC PARAMETERS DO NOT AFFECT THE TREATMENT OUTCOME OF INTRAVESICAL 100U ONABOTULINUMTOXINA INJECTION FOR PATIENTS WITH IDIOPATHIC DETRUSOR OVERACTIVITY

INTRODUCTION AND OBJECTIVES: Intravesical injection of onabotulinumtoxinA (BoNT-A) provides effective treatment for idiopathic detrusor overactivity (IDO). However, not all patients have successful long-term therapeutic effect. This study investigated the affect of baseline urodynamic parameters on the therapeutic effect and adverse events after injecting 100U onabotulinumtoxinA in patients with IDO refractory to antimuscarinics. METHODS: A total of 174 patients who received the first single intravesical BoNT-A 100U injection for refractory IDO were included. The success rate was determined based on patient perception of bladder condition (PPBC) improved by 2 scales. The short-term (3 months) and long-term (up to 24 months) success rates were analyzed according to the baseline urodynamic parameters including cystometric bladder capacity, maximum flow rate, postvoid residual, voiding efficiency, and DO subtypes. The BoNT-A related adverse events were also reported. RESULTS: A successful outcome was reported by 138 (79.3%) patients at 3 months. The baseline urodynamic parameters did not affect the success rates except that patients with phasic DO had a significantly higher success rate at 3 months than patients with terminal DO. Patients with a baseline PVR 100ml had a higher rate of acute urinary retention and needed straining to void. However, long-term success rates upto 24 months showed no significant difference between patients with different urodynamic parameters. CONCLUSIONS: Except for patients with phasic DO, the baseline urodynamic parameters did not affect the treatment outcome of intravesical injection of 100U onabotulinumtoxinA for IDO. However, the occurrence of AUR and difficult urination were significantly greater in patients with baseline PVR of 100ml.

Do baseline urodynamic parameters affect the treatment outcome after intravesical 100 U onabotulinumtoxinA injection in patients with idiopathic detrusor overactivity?

ObjectivesIntravesical injection of onabotulinumtoxinA (BoNT-A) provides effective treatment for idiopathic detrusor overactivity (IDO). However, not all patients have successful long-term therapeutic effects. This study investigated the effects of baseline urodynamic parameters on the therapeutic outcome, after injecting 100 U BoNT-A in patients with IDO. Materials and MethodsA total of 174 patients who received a first single intravesical BoNT-A 100 U injection for refractory IDO were included. A successful outcome was defined as an improvement of at least two points on a patient perception of bladder condition scale, which was scored from 0 to 6. The short-term (3 months) and long-term (up to 24 months) success rates were analyzed according to baseline urodynamic parameters, including cystometric bladder capacity, maximum flow rate, postvoid residual, voiding efficiency, and detrusor overactivity (DO) subtypes. BoNT-A- related adverse events were also reported. ResultsA successful outcome was reported by 138 (79.3%) patients at 3 months. The baseline urodynamic parameters did not affect the success rates, except that patients with phasic DO had a significantly higher success rate at 3 months than patients with terminal DO. Patients with a baseline postvoid residual (PVR) > 100mL, had higher rates of acute urinary retention and need to strain to void. However, long-term success rates up to 24 months showed no significant differences between patients with different urodynamic parameters. ConclusionsExcept for patients with phasic DO, the baseline urodynamic parameters did not affect the treatment outcome of intravesical injection of 100 U BoNT-A for IDO. However, acute urinary retention and difficult urination occurred more often in patients with a baseline PVR of > 100mL.

Reduction of urgency severity is associated with long‐term therapeutic effect after intravesical onabotulinumtoxina injection for idiopathic detrusor overactivity

Intravesical onabotulinumtoxin A (BoNT-A) injection is a promising treatment for refractory detrusor overactivity (DO). This study investigated the long-term success rate of BoNT-A injection for patients with idiopathic DO and its association with reduction of urgency severity. This study was a retrospective analysis of 174 patients with idiopathic DO who received first-time 100 U BoNT-A injections. The patients were collected from several previous clinical trials. The therapeutic effects were classified as significant sensory effects with urgency severity score reductions of ≥2 and/or significant motor effects with cystometric bladder capacity increases of ≥25%. The treatment results based on patients' perceptions of bladder conditions and long-term success rates were analyzed among the different therapeutic-effect subgroups. A successful outcome was reported by 138 (79.3%) patients at 3 months. Seventy-seven (44.3%) patients had both sensory and motor effects, 5 (2.9%) had sensory effects alone, 83 (47.7%) had motor effects alone, and 9 (5.2%) had no sensory or motor effect. All 82 patients with sensory with/without motor effects reported a successful result. In contrast, only 50 (60.2%) patients with motor effects alone reported success at 3 months. Increased cystometric bladder capacity and postvoid residual and decreased voiding efficiency were noted in patients with motor with/without sensory effects. The therapeutic results lasted significantly longer in patients with sensory with/without motor effects than those with motor effects alone. Improvement of urgency severity is significantly associated with a higher success rate at 3 months and longer therapeutic duration after intravesical BoNT-A injection for IDO.