Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction
| Status: | Completed |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | November 2012 |
| End Date: | March 30, 2018 |
Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms
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.
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.
The investigators aim to show that the addition of Tolterodine ER to Tamsulosin will provide
added benefits in ameliorating stent related symptoms in patients who have had unilateral
placement of a ureteral stent for urolithiasis. This objective will be assessed by
determining the mean difference in the urinary symptom index domain of the Urinary Stent
Symptom Questionnaire, which is a validated tool used to assess stent symptoms1. The
investigators felt that a 15% further decrease in the index score in the experimental group,
compared to the control group would represent a clinically significant improvement in urinary
symptoms, based on the prior studies evaluating lower urinary tract symptoms in patients with
stents. The investigators hypothesize that combination therapy with Tamsulosin and
Tolterodine ER will yield greater symptom relief than tamsulosin alone.
Initially, we conducted a 7-day design to determine whether combination therapy with
Tolterodine ER and Tamsulosin is more effective than monotherapy with tamsulosin alone in
reducing stent symptoms. 80 patients were enrolled and completed the study (15 patients
enrolled but withdrawn, 95 patients in total), the data analysis shows no benefit from being
on combination therapy likely secondary to the short duration of therapy. Kaplan et al. found
no difference in urinary symptoms between placebo and tolterodine ER at 1 week, however by
week 4 of medication therapy tolterodine ER was significantly better than placebo at
improving urinary symptoms (Kaplan SA, Schneider T, Foote JE, et al. Superior efficacy of
fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head,
placebo-controlled trial, BJUI 107: 1432-1440.) Given the evidence that tolterodine ER
requires a longer duration to have maximum benefit, we decide to increase the duration of
medication to start 2 weeks prior to surgery and continued for 7 days after surgery, for a
total of 21 days of medication, to test whether combination therapy is more effective than
monotherapy in reducing stent symptoms
added benefits in ameliorating stent related symptoms in patients who have had unilateral
placement of a ureteral stent for urolithiasis. This objective will be assessed by
determining the mean difference in the urinary symptom index domain of the Urinary Stent
Symptom Questionnaire, which is a validated tool used to assess stent symptoms1. The
investigators felt that a 15% further decrease in the index score in the experimental group,
compared to the control group would represent a clinically significant improvement in urinary
symptoms, based on the prior studies evaluating lower urinary tract symptoms in patients with
stents. The investigators hypothesize that combination therapy with Tamsulosin and
Tolterodine ER will yield greater symptom relief than tamsulosin alone.
Initially, we conducted a 7-day design to determine whether combination therapy with
Tolterodine ER and Tamsulosin is more effective than monotherapy with tamsulosin alone in
reducing stent symptoms. 80 patients were enrolled and completed the study (15 patients
enrolled but withdrawn, 95 patients in total), the data analysis shows no benefit from being
on combination therapy likely secondary to the short duration of therapy. Kaplan et al. found
no difference in urinary symptoms between placebo and tolterodine ER at 1 week, however by
week 4 of medication therapy tolterodine ER was significantly better than placebo at
improving urinary symptoms (Kaplan SA, Schneider T, Foote JE, et al. Superior efficacy of
fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head,
placebo-controlled trial, BJUI 107: 1432-1440.) Given the evidence that tolterodine ER
requires a longer duration to have maximum benefit, we decide to increase the duration of
medication to start 2 weeks prior to surgery and continued for 7 days after surgery, for a
total of 21 days of medication, to test whether combination therapy is more effective than
monotherapy in reducing stent symptoms
Inclusion Criteria:
- Patients with unilateral ureteral stent placement for urolithiasis
Exclusion Criteria:
1. Pre-existing lower urinary tract symptoms
2. Active urinary tract infection
3. Contraindication to anticholinergic medication
1. Prior hypersensitivity or allergy to tolterodine
2. Patients with severe hepatic impairment (Child-Pugh Class C)
3. Patients with uncontrolled close (narrow) angle glaucoma
4. Patients with urinary retention
4. Current anticholinergic use
5. Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)
6. Women who are pregnant or nursing
7. Under 18 years of age
8. Prior hypersensitivity or allergy to tolterodine
9. Patients with severe hepatic impairment (Child-Pugh Class C)
10. Patients with uncontrolled close (narrow) angle glaucoma
11. Patients with urinary retention
12. Unable to provide informed consent
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