Medical Expulsive Therapy of Single Distal Ureteral Stones

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00831701
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 3.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi	Drug: Tamsulosin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tamsulosin Tamsulosin treatment	Drug: Tamsulosin; 0.4 mg Tamsulosin once daily for 21 days; Other Names: Pradif Flomax
Placebo Comparator: Placebo Placebo treatment	Drug: Placebo; One placebo pill per day for 21 days or until stone expulsion

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

3. 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).

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, University Hospital Zürich, Switzerland	Zurich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00831701
• Other Study ID Numbers: 1-Hermanns
• First Posted: Jan 29, 2009
• Last Update Posted: May 25, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: Adrenergic alpha antagonists; drug therapy; tamsulosin; ureter
• Additional relevant MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi; Tamsulosin

Study Results

Participant Flow

Recruitment Details	Randomisation of 100 pts between 09.2006 and 09.2008 in a University Hospital
Pre-assignment Detail	10 patients were excluded from the final analysis due to stone expulsion before medication intake or withdrew of consent

Arm/Group Title	Tamsulosin Treatment	Placebo Treatment
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily	Patients received Placebo pill once daily
Period Title: Overall Study
STARTED	50	50
COMPLETED	45	45
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Tamsulosin Treatment	Placebo Treatment	Total
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily	Patients received Placebo pill once daily	Total of all reporting groups
Overall Participants	50	50	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	48 96%	45 90%	93 93%
>=65 years	2 4%	5 10%	7 7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.2 (12.7)	43.4 (13.9)	40.8 (13.5)
Sex: Female, Male (Count of Participants)
Female	8 16%	11 22%	19 19%
Male	42 84%	39 78%	81 81%
Region of Enrollment (participants) [Number]
Switzerland	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin Treatment	Placebo Treatment
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily	Patients received Placebo pill once daily
Measure Participants	45	45
Number [Participants]	39 78%	40 80%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin Treatment	Placebo Treatment
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily	Patients received Placebo pill once daily
Measure Participants	45	45
Median (Inter-Quartile Range) [days]	7	10

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin Treatment	Placebo Treatment
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily	Patients received Placebo pill once daily
Measure Participants	45	45
Median (Inter-Quartile Range) [pills per day]	3	7

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin Treatment	Placebo Treatment
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily	Patients received Placebo pill once daily
Measure Participants	45	45
Median (Full Range) [Units on a scale]	3	7

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin Treatment	Placebo Treatment
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily	Patients received Placebo pill once daily
Measure Participants	45	45
Number [participants]	6 12%	4 8%

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Tamsulosin Treatment		Placebo Treatment
Arm/Group Description	Patients received one pill of Tamsulosin 400 micrograms once daily		Patients received Placebo pill once daily
All Cause Mortality
	Tamsulosin Treatment		Placebo Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tamsulosin Treatment		Placebo Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Tamsulosin Treatment		Placebo Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/45 (8.9%)		1/45 (2.2%)
Gastrointestinal disorders
Diarrhoea	1/45 (2.2%)	1	0/45 (0%)	0
General disorders
Dizziness	0/45 (0%)	0	1/45 (2.2%)	1
Reproductive system and breast disorders
Retrograde ejaculation	2/45 (4.4%)	2	0/45 (0%)	0
Skin and subcutaneous tissue disorders
Cutaneous reaction (mild)	1/45 (2.2%)	1	0/45 (0%)	0

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.