N35
Conditions
Interventions
Group 1: Drug-coated balloon dilatation catheter
Group 2: Internal urethrotomy
Sponsors
Gesundheitsforen Leipzig GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Capacity to consent - Existence of a consent form dated and signed by the patient - Compliance of the patient - Willingness to participate in the one-year follow-up phase - Cystoscopic or urethrogram-confirmed diagnosis of symptomatic, short-segment recurrent stricture of the anterior urethra (= 2 cm) - At least 1 previous UI due to short-segment urethral stricture of the anterior urethra (= 2 cm)
Exclusion criteria
Exclusion criteria: - Previous or current participation in studies with the same indication - Previous Optilume® surgery - Known hypersensitivity and/or severe allergies to paclitaxel or structural analogues or other components of the medical device - Patients with strictures that cannot be passed with a 0.038-inch (0.97 mm) guidewire - History of anterior urethral urethroplasty - Previous hypospadias repair - Diagnosis of lichen sclerosus or stricture due to balanitis xerotica obliterans (BXO) - Presence of an artificial urethral sphincter, loops or stents in the urethra or prostate - Existing bladder or urinary tract infection - Obstructive voiding symptom not attributable to the stricture - Benign bladder neck stricture - Radical prostatectomy - Untreated stress incontinence - Radiation cystitis - Overactive bladder - Known neurogenic bladder, sphincter abnormalities or poor detrusor muscle function - Malignancy within the last two years - Chronic renal failure and treatment with haemodialysis - Currently uncontrolled diabetes (haemoglobin A1c > 8.0%) or signs of poor wound healing due to diabetes - Diagnosis or suspicion of primary neurological diseases such as multiple sclerosis or Parkinson's disease or other neurological diseases that impair bladder function, sphincter function or detrusor muscle function - Current use of alpha-blockers, anticonvulsants and antispasmodics, or use within the last 4 weeks prior to study inclusion - Regular use or planned use of Botox (onabotulinumtoxin A) in the urinary tract within the next 90 days - Invisible and visible haematuria - Unwillingness to have protected sexual intercourse for 30 days after treatment - Unwillingness to have protected sexual intercourse or to abstain for 90 days after treatment if the sexual partner is fertile - Existing PSA levels that are considered suspicious for prostate cancer according to current guidelines and clinical assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome consisting of two components (both components must be fulfilled to achieve the primary outcome) - Clinically relevant symptom improvement in the International Prostate Score (IPSS) of at least 6 points (15 % scale range) compared to baseline after 12 months and - Freedom from clinically indicated reinterventions within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual components of the primary outcome - Symptom improvement measured as a clinically relevant improvement in the International Prostate Score (IPSS) of at least 6 points (15% scale range) compared to baseline after 12 months - Freedom from clinically indicated reinterventions within 12 months - Urinary tract-related morbidity - Indicated reintervention - Time to reintervention - Recurrence of stricture symptoms - Recurrent urinary tract infections - Acute urinary retention - Pain before and after treatment measured on the visual analog scale (VAS) - Change in erectile dysfunction measured using the International Index of Erectile Function (IIEF-5) - Anatomical success measured by improvement in maximum urinary flow rate (Qmax including sonographic determination of residual urine volume) - Change in quality of life measured using the Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM) - Adverse events - Health economics - Duration of surgery - Type and number of personnel involved in the surgery - Postoperative outpatient visits due to the existing indication (number of visits and type of specialist) | — |
Countries
Germany
Contacts
Public ContactMelanie Penke
Gesundheitsforen Leipzig GmbH
Outcome results
None listed