NCT03799120

Brief Summary

A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

January 4, 2019

Last Update Submit

February 22, 2019

Conditions

Ureteral Diseases

Outcome Measures

Primary Outcomes (1)

  • Ureteric Stent Symptoms Questionnaire

    Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.

    1 week post-stent placement

Study Arms (2)

tamsulosin QD + Placebo

PLACEBO COMPARATOR

0.4 mg tamsulosin QD + Placebo QD

Drug: Tamsulosin BIDOther: Placebo

tamsulosin BID

EXPERIMENTAL

0.4 mg tamsulosin BID

Drug: Tamsulosin BID

Interventions

Tamsulosin BIDDRUG

comparison of once daily versus twice daily tamsulosin

tamsulosin BIDtamsulosin QD + Placebo
PlaceboOTHER

Placebo

tamsulosin QD + Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 and 70 years old.
  • Planning to undergo ureteroscopy with ureteral stent placement at our site.
  • Able to read and understand an English language survey (USSQ).

You may not qualify if:

  • Patients who are unable to provide informed consent.
  • Patients who are already taking an alpha-blocker.
  • Patients with hypersensitivity or known adverse side effects of tamsulosin or its ingredients and those who are not candidates for tamsulosin per attending Urologist discretion.
  • Patients with a preexisting bladder condition including UTI within 30 days of the procedure.
  • Patients with hepatitis C on boceprevir.
  • Patients who have medical conditions known to be associated with chronic pain, those taking medications for chronic pain such as gabapentin or a chronic opioid per the judgement of the PI, or those with a pain contract on file.
  • Women who are pregnant or planning to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (5)

  • Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23.

    PMID: 27125392BACKGROUND

  • Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19.

    PMID: 29923014BACKGROUND

  • Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.

    PMID: 12576846BACKGROUND

  • Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.

    PMID: 21453351BACKGROUND

  • Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29.

    PMID: 27809592BACKGROUND

MeSH Terms

Conditions

Ureteral Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Matthew Ferroni, MD

    Gundersen Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Researcher / study coordinator

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 10, 2019

Study Start

February 18, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)