Phase 4
Completed N=181
Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction
Ureteral Obstruction
Source: ClinicalTrials.gov NCT01741454 ↗
Enrolled (actual)
181
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion — 1.76; 1.84; 2.02; 1.93 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether combination therapy with Tolterodine ER and Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent symptoms. The second purpose is to determine if people have less stent discomfort if they take these medications starting 2 weeks before the stent is placed
The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will provide added benefits in reducing stent symptoms in patients who have had unilateral placement of a ureteral stent.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion |
1.76; 1.84; 2.02; 1.93; 1.95; 2.13 | — |
| PRIMARY Ureteral Stent Symptom Questionnaire Score |
2.95; 2.91; 2.98; 2.83; 2.66; 2.89 | — |
| PRIMARY Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion |
2.46; 2.55; 2.49; 2.46; 2.39; 2.49 | — |
| PRIMARY Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal |
1.72; 1.91; 1.85; 2.14; 1.66; 1.66 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with unilateral ureteral stent placement for urolithiasis
Exclusion Criteria
- Pre-existing lower urinary tract symptoms
- Active urinary tract infection
- Contraindication to anticholinergic medication
- Prior hypersensitivity or allergy to tolterodine
- Patients with severe hepatic impairment (Child-Pugh Class C)
- Patients with uncontrolled close (narrow) angle glaucoma
- Patients with urinary retention
- Current anticholinergic use
- Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)
- Women who are pregnant or nursing
- Under 18 years of age
- Prior hypersensitivity or allergy to tolterodine
- Patients with severe hepatic impairment (Child-Pugh Class C)
- Patients with uncontrolled close (narrow) angle glaucoma
- Patients with urinary retention
- Unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT01741454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.