Condition category
Urological and Genital Diseases
Date applied
11/05/2010
Date assigned
07/06/2010
Last edited
07/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francisco Anglada-Curado

ORCID ID

Contact details

Av Menendez Pidal sn
Reina Sofia Universitary Hospital
Urology Unit
Cordoba
14011
Spain
+34 (0)957 01 10 57
ancusr@ono.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

Universitary Hospital Reina Sofia Ethics Board approved in July 2008

Study design

Randomised single-blind single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Pethidine

Primary outcome measures

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 trial start date

01/09/2008

Overall trial end date

15/01/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

154 patient, 77 in each arm

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

15/01/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Av Menendez Pidal sn
Cordoba
14011
Spain

Sponsor information

Organisation

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

Sponsor details

Av Menendez Pidal sn.
Reina Sofia Universitary Hospital
Urology Unit
Cordoba
14011
Spain
+34 957 01 10 57
ancusr@ono.com

Sponsor type

Research organisation

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Reina Sofia Universitary Hospital (Spain) - Urology Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes