Influence of the frequency of shock waves on the effectiveness of extracorporeal shock wave lithotripsy in distal ureteral calculi

ISRCTN	ISRCTN02582855
DOI	https://doi.org/10.1186/ISRCTN02582855
Secondary identifying numbers	N/A

Submission date: 11/05/2010
Registration date: 07/06/2010
Last edited: 07/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francisco Anglada-Curado
Scientific

Av Menendez Pidal sn
Reina Sofia Universitary Hospital
Urology Unit
Cordoba
14011
Spain

Phone	+34 (0)957 01 10 57
Email	ancusr@ono.com

Study information

Study design	Randomised single-blind single centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised single-blind study to assess if a decreased shock wave frequency implements the efficacy of fragmentation rate in distal ureteral calculi
Study objectives	Extracorporeal lithotripsy devices apply treatment in a wide range of frequencies. Several studies in animals and humans have shown that the fragmentation is greater with decreasing frequency, in the lithiasis located in kidney and/or proximal urether. This study aims to demonstrate that the application of lithotripsy in distal ureter is more efficient at 60 beats per minute, compared with treatments applied at 80 pulses per minute.
Ethics approval(s)	Universitary Hospital Reina Sofia Ethics Board approved in July 2008
Health condition(s) or problem(s) studied	Ureteral lithiasis
Intervention	Higher frequencies are often used in lithotripsy because they consume less time. Lithotripsy is performed in this study within the specifications allowed by the equipment. Patients are randomised into two arms: 1. Patients receive lithotripsy at 60 beats per minute 2. Patients receive lithotripsy at 80 beats per minute In the two treatment arms pethidine is used as analgesic. The maximum duration of each session is fifty minutes. The maximum number of sessions is three. The estimated maximum follow-up is for three months.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Pethidine
Primary outcome measure	Number of pulses required for treatment success, measured at the end of follow-up.
Secondary outcome measures	1. Days to total expulsion of fragments: days required from first session to total elimination of stones, measured at the end of follow-up 2. Total number of sessions required: one to three, measured at the end of the follow-up 3. Success rate, measured at the end of the follow-up
Overall study start date	01/09/2008
Completion date	15/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	154 patient, 77 in each arm
Key inclusion criteria	1. Patients with ureteral radiopaque lithiasis subsidiary of lithotripsy treatment 2. Aged greater than 18 years, either sex 3. Lithiasis located in distal ureter 4. Lithiasis size greater than 0.5 cm and less than 1 cm
Key exclusion criteria	1. Aged less than 18 years 2. Medical contraindication for lithotripsy 3. Lithiasis less than 0.5 cm and greater than 1 cm 4. Other localisation than distal ureter 5. Indwelling ureteral catheter 6. Nephrostomy catheter 7. Severe hydronephrosis with kidney function impairment
Date of first enrolment	01/09/2008
Date of final enrolment	15/01/2010

Locations

Countries of recruitment

Spain

Study participating centre

Av Menendez Pidal sn

Cordoba
14011
Spain

Sponsor information

Association of Urology Research and Development (Asociacion de Urologia y Desarrollo de la Investigacion) (Spain)
Research organisation

Av Menendez Pidal sn.
Reina Sofia Universitary Hospital
Urology Unit
Cordoba
14011
Spain

Phone	+34 957 01 10 57
Email	ancusr@ono.com
"ROR"	https://ror.org/039xbga15

Funders

Funder type

Hospital/treatment centre

Reina Sofia Universitary Hospital (Spain) - Urology Unit

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan