UreterolithiasisPhase 3TAMSULOSINENCT00151567
Evaluation of Tamsulosin in the Treatment of Ureteral Stones
A Phase 3 study testing Tamsulosin in people with Ureterolithiasis and Ureteral Calculi, run by Rennes University Hospital at 6 sites in France.
Trial summary
Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureterolithiasis, Ureteral Calculi
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 6 sitesFrance
- Study dates
- Feb 2002to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over 18 years
- Emergency admission for a ureteral colic
- Radio-opaque ureterolithiasis
- Stone of 2 to 7 mm diameter
- Informed written consent
Who cannot join
- Pregnancy or breast-feeding
- Treatment with alpha or beta-blocker
- Contraindication to tamsulosin (orthostatic hypertension, hepatic failure)
- Complication needing surgery
- Calculi spontaneous passage before randomization
- Patient not available for a 6 week follow-up
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Service d'Urologie- Hôpital du Val de Grâce
Paris, 75005
Service d'Urologie - Hôpital de La Milétrie
Poitiers, 86021
Hôpital de Redon
Redon, 35600
Service d'Urologie- Hôpital Robert Debré
Reims, 51092
Service d'Urologie- Hôpital Pontchaillou
Rennes, 35033
Service d'Urologie - Hôpital Bretonneau
Tours, 37044
About this study
Official title: Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones
Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
Read the detailed description
Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs.
Alpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.
- Conditions
- Ureterolithiasis, Ureteral Calculi
- Being tested
- Tamsulosin, Placebo
- Keywords
- Ureterolithiasis, Alpha1-blocker, Lower ureteral stone
- Medical subject headings
- Ureterolithiasis, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
PlaceboDrug
Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tamsulosin Receives: Drug: Tamsulosin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to stone elimination in days (censored criterion)
Measured: between day 1 and 42
Secondary outcomes (11)
Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)
Measured: between day 1 and 42
Pain using Visual Analogue Scale
Measured: days 1, 2, 3
Spontaneous stone elimination rate
Measured: days 1, 7, 14, 21, 28, 35, and 42
Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
Measured: days 1, 7, 14, 21, 28, 35, and 42
Rate of need for surgery
Measured: Within 42 days
Time to surgery in days in patients with surgical elimination
Measured: between day 1 and day 42
Rate of pain recurrences
Measured: within 42 days
Time to the first recurrence in days
Measured: between day 1 and day 42
Rate of need for corticoids or morphine
Measured: Within 42 days
Time to the first administration of corticoids or morphine in days
Measured: between day 1 and day 42
Rate of adverse events
Measured: Within 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startFeb 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UreterolithiasisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Yamanouchi
- Investigators
- Francois Guillé, MD, Principal investigator, Rennes University HospitalEric Bellissant, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151567
- Sponsor's protocol ID
- AFSSAPS 010751
- Other IDs
- PHRC/00-01, CIC0203/004
- Acronym
- TAMSULOSINE
- Status last verified
- Sep 2008
- First submitted
- 8 Sep 2005
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Resim S, Ekerbicer H, Ciftci A. Effect of tamsulosin on the number and intensity of ureteral colic in patients with lower ureteral calculus. Int J Urol. 2005 Jul;12(7):615-20. doi: 10.1111/j.1442-2042.2005.01116.x.
PubMed 16045553Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. doi: 10.2165/00003495-199652060-00012.
PubMed 8957159Vincendeau S, Bellissant E, Houlgatte A, Dore B, Bruyere F, Renault A, Mouchel C, Bensalah K, Guille F; Tamsulosin Study Group. Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial. Arch Intern Med. 2010 Dec 13;170(22):2021-7. doi: 10.1001/archinternmed.2010.447.
PubMed 21149761
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones
- ClinicalTrials.gov ID
- NCT00151567
- Acronym / sponsor ID
- TAMSULOSINE / AFSSAPS 010751
- Conditions
- Ureterolithiasis, Ureteral Calculi
- Keywords
- Ureterolithiasis, Alpha1-blocker, Lower ureteral stone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Yamanouchi
- Study start
- Feb 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
Detailed description
Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs.
Alpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TamsulosinTamsulosin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult over 18 years
- Emergency admission for a ureteral colic
- Radio-opaque ureterolithiasis
- Stone of 2 to 7 mm diameter
- Informed written consent
Key exclusion criteria (6 listed)
- Pregnancy or breast-feeding
- Treatment with alpha or beta-blocker
- Contraindication to tamsulosin (orthostatic hypertension, hepatic failure)
- Complication needing surgery
- Calculi spontaneous passage before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinOral tamsulosin once a day until stone elimination or the end of the follow-up (42 days) | Drug | 1 |
| PlaceboOral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days) | Drug | 2 |
Primary outcome
Time to stone elimination in days (censored criterion)
Time frame: between day 1 and 42
11 secondary outcomes
Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)
Time frame: between day 1 and 42
Pain using Visual Analogue Scale
Time frame: days 1, 2, 3
Spontaneous stone elimination rate
Time frame: days 1, 7, 14, 21, 28, 35, and 42
Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)
Time frame: days 1, 7, 14, 21, 28, 35, and 42
Rate of need for surgery
Time frame: Within 42 days
Time to surgery in days in patients with surgical elimination
Time frame: between day 1 and day 42
Rate of pain recurrences
Time frame: within 42 days
Time to the first recurrence in days
Time frame: between day 1 and day 42
Rate of need for corticoids or morphine
Time frame: Within 42 days
Time to the first administration of corticoids or morphine in days
Time frame: between day 1 and day 42
Rate of adverse events
Time frame: Within 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Background: PubMed 16045553Resim S, Ekerbicer H, Ciftci A. Effect of tamsulosin on the number and intensity of ureteral colic in patients with lower ureteral calculus. Int J Urol. 2005 Jul;12(7):615-20. doi: 10.1111/j.1442-2042.2005.01116.x.
- Background: PubMed 8957159Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. doi: 10.2165/00003495-199652060-00012.
- Derived from this study: PubMed 21149761Vincendeau S, Bellissant E, Houlgatte A, Dore B, Bruyere F, Renault A, Mouchel C, Bensalah K, Guille F; Tamsulosin Study Group. Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial. Arch Intern Med. 2010 Dec 13;170(22):2021-7. doi: 10.1001/archinternmed.2010.447.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Guillé, MD principal investigator
Rennes University Hospital
Eric Bellissant, MD, PhD study chair
Rennes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin in people with Ureterolithiasis and Ureteral Calculi, run by Rennes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to stone elimination in days (censored criterion) (time frame: between day 1 and 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151567, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.