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Medical Expulsive Therapy of Single Distal Ureteral Stones

Primary Purpose

Ureteral Calculi

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Calculi focused on measuring Adrenergic alpha antagonists, drug therapy, tamsulosin, ureter

Eligibility Criteria

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

Inclusion criteria:

  • patients with a single 2 to 7mm ureteral stone below the common iliac vessels

Exclusion criteria:

  • presence of multiple ureteral stones
  • renal insufficiency (glomerular filtration rate below 60 ml/min)
  • urinary tract infection
  • a solitary kidney
  • pregnancy
  • history of ureteral surgery or previous endoscopic procedure
  • hypersensitivity to tamsulosin
  • current alpha-blocker, calcium-antagonist or corticosteroid medication

Sites / Locations

  • Department of Urology, University Hospital Zürich, Switzerland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tamsulosin

Placebo

Arm Description

Tamsulosin treatment

Placebo treatment

Outcomes

Primary Outcome Measures

Number of Participants With Stone Expulsion
The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).

Secondary Outcome Measures

Time to Stone Passage
The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.
Required Analgesics
Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day
Maximum Daily Pain Score
All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).
Number of Participants Requiring Active Treatment
The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.

Full Information

First Posted
November 19, 2008
Last Updated
May 19, 2010
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00831701
Brief Title
Medical Expulsive Therapy of Single Distal Ureteral Stones
Official Title
Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics. The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi. Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi
Keywords
Adrenergic alpha antagonists, drug therapy, tamsulosin, ureter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm Description
Tamsulosin treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Pradif, Flomax
Intervention Description
0.4 mg Tamsulosin once daily for 21 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo pill per day for 21 days or until stone expulsion
Primary Outcome Measure Information:
Title
Number of Participants With Stone Expulsion
Description
The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Time to Stone Passage
Description
The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.
Time Frame
21 days
Title
Required Analgesics
Description
Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day
Time Frame
Until stone expulsion or up to 21 days
Title
Maximum Daily Pain Score
Description
All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).
Time Frame
Until stone expulsion or up to 21 days
Title
Number of Participants Requiring Active Treatment
Description
The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: patients with a single 2 to 7mm ureteral stone below the common iliac vessels Exclusion criteria: presence of multiple ureteral stones renal insufficiency (glomerular filtration rate below 60 ml/min) urinary tract infection a solitary kidney pregnancy history of ureteral surgery or previous endoscopic procedure hypersensitivity to tamsulosin current alpha-blocker, calcium-antagonist or corticosteroid medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
Department of Urology, University Hospital Zürich, Switzerland
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19375849
Citation
Hermanns T, Sauermann P, Rufibach K, Frauenfelder T, Sulser T, Strebel RT. Is there a role for tamsulosin in the treatment of distal ureteral stones of 7 mm or less? Results of a randomised, double-blind, placebo-controlled trial. Eur Urol. 2009 Sep;56(3):407-12. doi: 10.1016/j.eururo.2009.03.076. Epub 2009 Apr 3.
Results Reference
derived

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Medical Expulsive Therapy of Single Distal Ureteral Stones

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