Trial · NCT00831701

Medical Expulsive Therapy of Single Distal Ureteral Stones

NCT00831701, Not applicable, Completed, University of Zurich; results first posted 2010-05-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Medical Expulsive Therapy of Single Distal Ureteral Stones. Trials, record NCT00831701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00831701

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Medical Expulsive Therapy of Single Distal Ureteral Stones
NCT number: NCT00831701
Status: Completed
Phases: Not applicable
Enrollment: 100 participants, actual
Lead sponsor: University of Zurich
Conditions: Ureteral Calculi
Interventions: Tamsulosin, Placebo
First posted: 2009-01-29
Last updated: 2010-05-25
Results first posted: 2010-05-12
Limitations and caveats: Not all patients were able to record the exact time of stone passage. Thus, the secondary end point of time to stone passage is based on Kaplan-Meier estimation.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Stone Expulsion	21 days	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	Time to Stone Passage	21 days	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.
Secondary	Required Analgesics	Until stone expulsion or up to 21 days	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
Secondary	Maximum Daily Pain Score	Until stone expulsion or up to 21 days	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).
Secondary	Number of Participants Requiring Active Treatment	21 days	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With Stone Expulsion	21 days	Participants	NUMBER
SECONDARY	Time to Stone Passage	21 days	days	MEDIAN
SECONDARY	Required Analgesics	Until stone expulsion or up to 21 days	pills per day	MEDIAN
SECONDARY	Maximum Daily Pain Score	Until stone expulsion or up to 21 days	Units on a scale	MEDIAN
SECONDARY	Number of Participants Requiring Active Treatment	21 days	participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Stone Expulsion	Tamsulosin Treatment	39		Participants
Number of Participants With Stone Expulsion	Placebo Treatment	40		Participants
Time to Stone Passage	Tamsulosin Treatment	7	Inter-Quartile Range 3 to 10	days
Time to Stone Passage	Placebo Treatment	10	Inter-Quartile Range 3 to 20	days
Required Analgesics	Tamsulosin Treatment	3	Inter-Quartile Range 1 to 9.8	pills per day
Required Analgesics	Placebo Treatment	7	Inter-Quartile Range 4 to 16	pills per day
Maximum Daily Pain Score	Tamsulosin Treatment	3	Full Range 0 to 10	Units on a scale
Maximum Daily Pain Score	Placebo Treatment	7	Full Range 0 to 9	Units on a scale
Number of Participants Requiring Active Treatment	Tamsulosin Treatment	6		participants
Number of Participants Requiring Active Treatment	Placebo Treatment	4		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tamsulosin Treatment	50
Overall Study	STARTED	Placebo Treatment	50
Overall Study	COMPLETED	Tamsulosin Treatment	45
Overall Study	COMPLETED	Placebo Treatment	45
Overall Study	NOT COMPLETED	Tamsulosin Treatment	5
Overall Study	NOT COMPLETED	Placebo Treatment	5

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Retrograde ejaculation	Reproductive system and breast disorders	Tamsulosin Treatment	2	45	2
other	Retrograde ejaculation	Reproductive system and breast disorders	Placebo Treatment	0	45	0
other	Diarrhoea	Gastrointestinal disorders	Tamsulosin Treatment	1	45	1
other	Diarrhoea	Gastrointestinal disorders	Placebo Treatment	0	45	0
other	Cutaneous reaction (mild)	Skin and subcutaneous tissue disorders	Tamsulosin Treatment	1	45	1
other	Cutaneous reaction (mild)	Skin and subcutaneous tissue disorders	Placebo Treatment	0	45	0
other	Dizziness	General disorders	Tamsulosin Treatment	0	45	0
other	Dizziness	General disorders	Placebo Treatment	1	45	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tamsulosin Treatment
Total, all-cause mortality	Placebo Treatment
Total, other adverse events	Tamsulosin Treatment	4	45
Total, other adverse events	Placebo Treatment	1	45
Total, serious adverse events	Tamsulosin Treatment	0	45
Total, serious adverse events	Placebo Treatment	0	45

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19375849	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tamsulosin Treatment vs Placebo Treatment: Number of Participants With Stone Expulsion	Trial comparisons
Tamsulosin Treatment vs Placebo Treatment: Number of Participants Requiring Active Treatment	Trial comparisons
Tamsulosin Treatment vs Placebo Treatment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00831701

GET https://conductscience.org/api/trials/v1/NCT00831701/registered

API reference For AI assistants