Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin | Active Comparator | Tamsulosin treatment |
|
| Placebo | Placebo Comparator | Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | 0.4 mg Tamsulosin once daily for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University Hospital Zürich, Switzerland | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19375849 | Derived | 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. |
Not provided
Not provided
10 patients were excluded from the final analysis due to stone expulsion before medication intake or withdrew of consent
Randomisation of 100 pts between 09.2006 and 09.2008 in a University Hospital
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin Treatment | Patients received one pill of Tamsulosin 400 micrograms once daily |
| FG001 | Placebo Treatment | Patients received Placebo pill once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin Treatment | Patients received one pill of Tamsulosin 400 micrograms once daily |
| BG001 | Placebo Treatment | Patients received Placebo pill once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | Participants | 21 days |
|
|
3 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamsulosin Treatment | Patients received one pill of Tamsulosin 400 micrograms once daily |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retrograde ejaculation | Reproductive system and breast disorders | Systematic Assessment | R.E. during medication |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Räto T. Strebel | Department of Urology, University Hospital Zürich, Switzerland | 0041-44-2551111 | raeto.strebel@ksgr.ch |
Not provided
| ID | Term |
|---|---|
| D014514 | Ureteral Calculi |
| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | One placebo pill per day for 21 days or until stone expulsion |
|
| 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 | Until stone expulsion or up to 21 days |
| 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). | Until stone expulsion or up to 21 days |
| 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. | 21 days |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | days | 21 days |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | pills per day | Until stone expulsion or up to 21 days |
|
|
|
| Secondary | 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). | Posted | Median | Full Range | Units on a scale | Until stone expulsion or up to 21 days |
|
|
|
| Secondary | 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. | Posted | Number | participants | 21 days |
|
|
|
| 0 |
| 45 |
| 4 |
| 45 |
| EG001 | Placebo Treatment | Patients received Placebo pill once daily | 0 | 45 | 1 | 45 |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Cutaneous reaction (mild) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |