Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer

Non-Muscle Invasive Bladder Cancer Clinical Trial

Official title:

Study of the Effect of Neoadjuvant Low Energy Shock Wave Therapy on Non-Muscle Invasive Bladder Cancer: A Preliminary Pilot Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644835
• Other study ID #: LESW-NMIBC
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2020
• Est. completion date: November 28, 2023

Study information

• Verified date: December 2020
• Source: Mansoura University
• Contact: Ahmed Elkashef
• Phone: +201000428981
• Email: ahmed-elkashef[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that low energy shock wave therapy (LESW) might induce damage to the tumor tissues of non-muscle invasive bladder cancer (NMIBC), so they could be ablated and detached from the surface. The patients who are suffering from NMIBC will be randomly allocated into two groups: The first group (control group): 25 patients will be exposed to sham treatment before transurethral resection of bladder tumor (TURBT) without using LESW therapy. The second group (LESW group): 25 patients will be exposed to LESW therapy before TURBT. The apoptotic effect of LESW will be studied via histopathological examination and molecular studies of the resected bladder tissues. The patients will receive intravesical chemotherapy or BCG immunotherapy and they will be followed up at outpatient clinic for two years by MRI, outpatient cystoscopy and cytology to identify the recurrence and progression rate of NMIBC.

Description:

The investigators hypothesize that low energy shock wave therapy (LESW) might induce damage to the tumor tissues of non-muscle invasive bladder cancer (NMIBC), so they could be ablated and detached from the surface. The patients who are suffering from NMIBC will be randomly allocated into two groups: The first group (control group): 25 patients will be exposed to sham treatment before transurethral resection of bladder tumor (TURBT) without using LESW therapy. The second group (LESW group): 25 patients will be exposed to LESW therapy before TURBT. 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 (US 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. The apoptotic effect of LESW will be studied via histopathological examination for the type of bladder tumor, pathological stage, grade, association of carcinoma in situ and morphological features of apoptosis in terms of compaction of the nuclear chromatin (pyknosis), loss of cellular volume and chromatin condensation on the nuclear envelope (nuclear crescents), Immunohistochemical analysis of anti-caspase-3 antibody and molecular studies of Bax (an apoptotic promotor), BCL-2 and Survivin (apoptotic inhibitors) Relative Gene Expression in the resected bladder tissues. The patients will receive intravesical chemotherapy or BCG immunotherapy and they will be followed up at outpatient clinic for two years by MRI, outpatient cystoscopy and cytology to identify the recurrence and progression rate of NMIBC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• Low Energy Shock Wave Treatment
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.
• Sham Treatment
The patients will be exposed to the same therapy head, which will also be fitted with a stand-off without energy transmission.

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center, Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression survival.		2 years
Primary	Recurrence-free survival.		2 years