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

NCT04644835 | Unknown

• 1 other identifier: LESW-NMIBC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Muscle Invasive Bladder Cancer

Keywords

NMIBC; LESW; TURBT

Outcome Measures

Primary Outcomes (2)

• Progression survival.

  2 years

• Recurrence-free survival.

  2 years

Study Arms (2)

LESW group

EXPERIMENTAL

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.

Device: Low Energy Shock Wave Treatment

Control group

SHAM COMPARATOR

This group of patients will be exposed to the same therapy head, which will also be fitted with a stand-off without energy transmission.

Device: Sham Treatment

Interventions

Low Energy Shock Wave Treatment DEVICE

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.

LESW group

Sham Treatment DEVICE

The patients will be exposed to the same therapy head, which will also be fitted with a stand-off without energy transmission.

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ≤ T1, de novo, single and small (\<3cm) papillary lesions will be included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ahmed A. Shokeir

  Urology and Nephrology Center, Mansoura University, Egypt

  STUDY CHAIR

• Ahmed Mosbah

  Urology and Nephrology Center, Mansoura University, Egypt

  STUDY DIRECTOR

• Ahmed Elkashef

  Urology and Nephrology Center, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Elkashef

CONTACT

+201000428981; ahmed-elkashef@hotmail.com

Ahmed Mosbah

CONTACT

+201062525591; amosbah64@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Urology, Urology and Nephrology Center, Principal Investigator

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: November 25, 2020
• Study Start: November 28, 2020
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2023
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)