SAFETY, FEASIBILITY AND PATIENT’S SUBJECTIVE SATISFACTION OF INTRADETRUSORIAL ONABOTULINUMTOXIN A TREATMENT IN OUTPATIENT CLINIC SETTING IN A LONG- TERM FOLLOW- UP

Gubbiotti M1, Giommoni V1, Bigazzi B1, Rosadi S1

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 493
Open Discussion ePosters
Scientific Open Discussion Session 104
Friday 19th September 2025
10:35 - 10:40 (ePoster Station 2)
Exhibition
Overactive Bladder Quality of Life (QoL) Urgency/Frequency Detrusor Overactivity
1. S. Maria la Gruccia Hospital, dept. of Urology, Montevarchi (Ar), Italy
Presenter
Links

Abstract

Hypothesis / aims of study
To evaluate the feasibility, safety and patient’s subjective satisfaction of intradetrusorial OnabotulinumtoxinA (Onabot/A) treatment performed in outpatient clinic setting, in both patients with idiopathic (i) and neurogenic (n) OAB.
Study design, materials and methods
Between July 2019 to March 2025, iOAB and nOAB patients were selected and treated with Onabot/A intradetrusorial injections in outpatient clinic setting (100 U in iOAB or 200 U in nOAB). Exclusion criteria were: spinal cord injury at or above the sixth thoracic segment, recurrent urinary tract infections (UTIs). Baseline and follow-up evaluation included: 3-day voiding diary, urinalyses and culture, uroflowmetry with post-void residual volume (PVR). The surgical protocol was performed as following: intravesical local anesthesia (lidocaine 2% diluted in 50 ml of normal saline) instilled into the bladder for 20 min; antibiotic prophylaxis for 3 days. Patients remained under observation for 60 minutes. The rate of intraoperative and postoperative complications, patients’ subjective satisfaction (VAS#1), and pain during the procedure (VAS#2) was assessed. The follow-up visit was scheduled as follows: at 1, 3 months after procedure and then every 6 months. Feasibility and safety were considered as the lack of major complications (bleeding, urosepsis, fever, symptomatic UTI, urinary retention lasting more than 10 days). Subjective patient’s satisfaction was achieved when VAS#1 and #2 were >6 (0: worse; 10: best). We also asked patients whether they would repeat the treatment with the same procedure protocol.
Results
We treated 80 patients (50 females, 30 males). Mean ± SD age was 62.8 ± 14.6. 62/80 (77.5%) were iOAB. Baseline and at last follow-up results are reported in Table 1. Mean ± SD follow- up: 60.2 ± 8.3 months. All findings were statistically improved. Repeated injections were performed in 47/80 patients (58.7%) with mean ± SD number of injections: 2.14 ± 0.4. Mean ± SD of VAS#1 and VAS#2 were 7.7 ± 0.4 and 4.9 ± 1.2, respectively. VAS#1 increased in patients underwent to repeated injections (p<0.001). No statistical differences were found between VAS#1 and VAS#2 in iOAB and nOAB (p<0.2, p<0.4). 29/80 (36.2%) had previous received Onabot/A injections in an in- patient setting, and VAS#1 score significantly increased (p< 0.001) in outpatient clinic setting. None of patients had episodes of bleeding or other major complications, during or after treatment. All the patients stated that they will repeat this procedure in local anesthesia.
Interpretation of results
Our results demonstrated that Onabot/A intradetrusorial injections in outpatient clinic setting is effective, well accepted and safe the long term follow- up. No relevant side effects and major complications occurred Level of referred pain was low, and compliance to the procedure was high.
Concluding message
To our knowledge this is one of the first study proposing a new treatment protocol of Onabot/a injections in outpatient clinic setting. This procedure was feasible, safe and well tolerated by patients.
Figure 1 Table 1. Baseline and last follow-up results.
Disclosures
Funding none Clinical Trial No Subjects Human Ethics Committee Review Institutional Board of S. Maria la Gruccia Hospital Helsinki Yes Informed Consent Yes
03/07/2025 08:47:54