Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Cancer
About this trial
This is an interventional treatment trial for Non-Muscle Invasive Bladder Cancer focused on measuring NMIBC; LESW; TURBT
Eligibility Criteria
Inclusion Criteria:
- Patients with ≤ T1, de novo, single and small (<3cm) papillary lesions will be included in the study.
Exclusion Criteria:
- Patients with ≥ T2 bladder cancer, evidence of nodal metastasis, associated upper tract urothelial carcinoma, morbidly obese patients, patients with absolute contraindication for shock wave therapy or those who refuse will be excluded from the study.
Sites / Locations
- Urology and Nephrology Center, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
LESW group
Control group
The shock wave applicator (Dornier AR2, shock wave device, Dornier MedTech 2010, Wessling, Germany) will be gently placed directly on the ultrasound transmission gel over the skin surface of the suprapubic region above the urinary bladder at the site of the papillary lesion (ultrasound guided) and at other five points. Points 1 and 2 will be at the level of transverse crease 2 cm above the pubic bone and 5 cm from each, points 3 and 4 will 2 cm above points 1 and 2, and point 5 will be centered of points 1-4. A total of 2000 pulses at 0.25 mJ/mm2 will be delivered with a frequency of 3 pulses per second. The position of the shock wave applicator will be changed after every 400 pulses.
This group of patients will be exposed to the same therapy head, which will also be fitted with a stand-off without energy transmission.