---
title: Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial
nct_id: NCT01061073
overall_status: COMPLETED
phase: PHASE3
sponsor: Poitiers University Hospital
study_type: INTERVENTIONAL
primary_condition: Non-oncological Indication to Ureteral Stenting
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01061073.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01061073"
ct_last_update_post_date: 2016-10-11
last_seen_at: "2026-05-12T06:19:23.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial

**NCT ID:** [NCT01061073](https://clinicaltrials.gov/study/NCT01061073)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 73
- **Lead Sponsor:** Poitiers University Hospital
- **Conditions:** Non-oncological Indication to Ureteral Stenting
- **Start Date:** 2010-01
- **CT.gov Last Update:** 2016-10-11

## Brief Summary

JJ ureteral stent represents an advance in the management of the upper urinary tract obstruction as it allows the patient to resume his activities although he is stented between the kidney and the bladder.

However, in many cases, this JJ stent is not well tolerated and can even be unbearable.

This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance of JJ stents compared to low-doses of phloroglucinol.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patients aged 18 or more.
2. Non-oncological indication to ureteral stenting
3. Informed written consent

Exclusion Criteria:

1 Any contra-indication to Tamsulosin or phloroglucinol (renal or hepatic insufficiency, allergy) 2. Pregnancy 3. Patients already treated with alpha blockers
```

## Arms

- **Omexel** (EXPERIMENTAL)
- **spasfon** (ACTIVE_COMPARATOR)

## Interventions

- **Omexel** (DRUG)
- **spasfon** (DRUG)

## Primary Outcomes

- **Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents** _(time frame: 1 month treatment)_

## Secondary Outcomes

- **incidence of complications** _(time frame: after 1 month treatment)_

## Locations (1)

- Poitiers University Hospital - 2 rue de la Milétrie, Poitiers, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.poitiers university hospital - 2 rue de la milétrie|poitiers||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01061073*  
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