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

Primary Purpose

Non-Muscle Invasive Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low Energy Shock Wave Treatment
Sham Treatment
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Muscle Invasive Bladder Cancer focused on measuring NMIBC; LESW; TURBT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Sham Comparator

Arm Label

LESW group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression survival.
Recurrence-free survival.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2020
Last Updated
December 17, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04644835
Brief Title
Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2020 (Actual)
Primary Completion Date
November 28, 2022 (Anticipated)
Study Completion Date
November 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Muscle Invasive Bladder Cancer
Keywords
NMIBC; LESW; TURBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LESW group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
This group of patients will be exposed to the same therapy head, which will also be fitted with a stand-off without energy transmission.
Intervention Type
Device
Intervention Name(s)
Low Energy Shock Wave Treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Treatment
Intervention Description
The patients will be exposed to the same therapy head, which will also be fitted with a stand-off without energy transmission.
Primary Outcome Measure Information:
Title
Progression survival.
Time Frame
2 years
Title
Recurrence-free survival.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elkashef
Phone
+201000428981
Email
ahmed-elkashef@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Mosbah
Phone
+201062525591
Email
amosbah64@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A. Shokeir
Organizational Affiliation
Urology and Nephrology Center, Mansoura University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Mosbah
Organizational Affiliation
Urology and Nephrology Center, Mansoura University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Elkashef
Organizational Affiliation
Urology and Nephrology Center, Mansoura University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center, Mansoura University
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Elkashef
Phone
+201000428981
Email
ahmed-elkashef@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan for whether to share IPD or not.

Learn more about this trial

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

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