Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

NCT01741454 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 2017-07552012-0279
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ureteral Obstruction

Keywords

Tolterodine; Tamsulosin; Ureteral Obstruction

Outcome Measures

Primary Outcomes (4)

• Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion

  The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.

  Up to 24 hours prior to stent insertion

• Ureteral Stent Symptom Questionnaire Score

  The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.

  42-48 hours post-stent insertion

• Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion

  The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.

  5-7 days post-stent insertion

• Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal

  The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.

  Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.

Study Arms (4)

Tamsulosin plus placebo 7-day treatment

ACTIVE COMPARATOR

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.

Drug: Tamsulosin

Tamsulosin plus Tolterodine ER 7-day treatment

EXPERIMENTAL

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms. Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.

Drug: Tamsulosin; Drug: Tolterodine ER

Tamsulosin plus placebo 21-day treamtnet

ACTIVE COMPARATOR

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.

Drug: Tamsulosin

Tamsulosin plus Tolterodine ER 21-day treatment

EXPERIMENTAL

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms. Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.

Drug: Tamsulosin; Drug: Tolterodine ER

Interventions

Tamsulosin DRUG

0.4 mg by mouth once per day.

Also known as: Flomax (TM)

Tamsulosin plus Tolterodine ER 21-day treatment; Tamsulosin plus Tolterodine ER 7-day treatment; Tamsulosin plus placebo 21-day treamtnet; Tamsulosin plus placebo 7-day treatment

Tolterodine ER DRUG

4 mg by mouth once a day.

Also known as: Detrol (TM)

Tamsulosin plus Tolterodine ER 21-day treatment; Tamsulosin plus Tolterodine ER 7-day treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral ureteral stent placement for urolithiasis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Ureteral Obstruction

Interventions

Tamsulosin; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Benzhydryl Compounds; Cresols; Phenols

Results Point of Contact

• Title: Shuang Li (Linda)
• Organization: University of Wisconsin School of Medicine & Public Health

lis@urology.wisc.edu

608.263.8336

Study Officials

• Stephen Nakada, MD

  Univeristy of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 5, 2012
• Study Start: November 1, 2012
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Locations

US (1)