N32.0
Conditions
Interventions
Group 1: All consecutive patients with recurrent bladder neck stenosis who undergo endoscopic dilation using a drug-coated balloon (Optilume® Drug-Coated Balloon, DCB) will be enrolled in the study. N
Sponsors
Urologische Praxis
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent for study participation and for the processing of personal data. Presence of symptomatic, endoscopically confirmed bladder neck stenosis following previous prostate surgery (e.g., TURP, HoLEP, radical prostatectomy, or laser therapy) with planned treatment using Optilume® balloon dilation. Ability and willingness of the patient to participate in the scheduled follow-up assessments, including completion of the IPSS and ICIQ-UI SF questionnaires and measurement of post-void residual urine volume. Sufficient proficiency in the German language to understand the informed consent discussion and patient information materials.
Exclusion criteria
Exclusion criteria: Age below 18 years. Absence of written informed consent for study participation and/or the processing of personal data. Lack of a confirmed diagnosis of bladder neck stenosis (e.g., another form of bladder outlet obstruction without involvement of the bladder neck). Planned alternative treatment in which Optilume® balloon dilation is not performed (e.g., primary open reconstructive surgery). Active urinary tract infection at the time of the planned procedure requiring antibiotic treatment and not adequately controlled. Known hypersensitivity or contraindication to paclitaxel or any other component of the Optilume® system. Uncontrolled severe coagulation disorder or any condition in which perioperative adjustment of anticoagulation therapy is not feasible. Severe comorbidities or a general medical condition that, in the investigator’s judgment, precludes treatment with Optilume® balloon dilation or participation in the study. Concurrent participation in another clinical trial that could interfere with the assessment of the safety or effectiveness of Optilume® treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the recurrence rate within 12 months following Optilume® balloon dilation of the bladder neck. Recurrence is defined as the development of symptomatic bladder neck stenosis and/or the need for any repeat intervention within 12 months after the procedure, including repeat endoscopic treatment, open surgical reconstruction, initiation of intermittent self-catheterization, or placement of a suprapubic catheter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the International Prostate Symptom Score (IPSS) from baseline to 6, 12, and, if available, 24 months following Optilume® balloon dilation. Change in the IPSS Quality of Life score (IPSS-QoL) from baseline to 6, 12, and, if available, 24 months. Change in the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) from baseline to 6, 12, and, if available, 24 months. Change in maximum urinary flow rate (Qmax) between the preoperative assessment and follow-up evaluations at 12 months (and, if available, 24 months). Change in post-void residual urine volume (PVR, assessed by ultrasound) from baseline to follow-up evaluations at 6, 12, and, if available, 24 months. Occurrence of early and late complications during the follow-up period, including their type, frequency, and severity, as well as the type and timing of any reinterventions. | — |
Countries
Germany
Contacts
Public ContactGeorgi Tosev
Urologische Praxis
Outcome results
None listed