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NCT05100017 · ClinicalTrials.gov registry record · NA

Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure

A NA study of Kidney Diseases and Nephrolithiasis, sponsored by Northwestern University.

Recruiting
Registry status
NA
Development phase
126
Enrollment target
1
Study location

NCT05100017 is a NA study of Kidney Diseases and Nephrolithiasis that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 126 participants, below the 1,782-participant average among 38 other Kidney Diseases trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05100017, a NA study of Kidney Diseases and Nephrolithiasis, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
NA
Development phase
126 participants
Enrollment target
1
Study location

Study Summary

Stone disease is a common condition, affecting approximately 9% of Americans in 2007. It causes great morbidity and is also a costly condition, estimated to cost the US healthcare system approximately 3.79 billion dollars in 2007. Ureteroscopy (URS) is the most commonly performed surgical treatment for upper tract stone disease. Ureteral stenting is a common practice after ureteroscopy and placed in \~75% of cases to prevent ureteral edema and renal obstruction. Unfortunately, ureteral stenting can be very painful and has been shown to increase the rate of emergency room visits. Many strategies have been attempted to decrease pain with ureteral stenting including modification of stent material and designs, but efforts so far have been unsuccessful in decreasing stent-related morbidity. Stent-related morbidity is hypothesized to be secondary to irritation of ureteral/bladder mucosa and muscle. Analgesics such as alpha blockers and NSAIDs have been shown to reduce stent morbidity. Anticholinergic drugs are also utilized as they decrease bladder spasms and, therefore, are hypothesized to reduce stent irritation. However, the evidence for anticholinergics has been conflicting. Anticholinergics also have a serious side effect profile including dry mouth, dry eyes, constipation, urinary retention, blurred vision, and even dementia. Some authors even hypothesize that these side effects may offset any purported benefits the anticholinergics provide for stent-morbidity. Methocarbamol is anti-spasmodic muscle relaxant that is believed to work by acting on central neurons and possibly by blocking sodium channels. Given that anticholinergics have many side effects and questionable efficacy, the investigators hypothesize that methocarbamol may achieve superior analgesia for stent morbidity and stent-related bladder spasms. Oxybutynin is used for the treatment of overactive bladder. The rationale is that the oxybutynin relaxes the muscles in the bladder to help decrease problem

Interventions

  • DRUG Methocarbamol
  • DRUG Oxybutynin

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2021-09-30
Est. Completion 2025-12
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT05100017

The ClinicalTrials.gov registry entry for NCT05100017 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,782-participant average among 38 other Kidney Diseases trials with a reported enrollment target (93% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Kidney Diseases appearing as the primary indexed condition, and to 2 interventions - of which Methocarbamol is the first listed.

NCT05100017 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT05100017 about?

NCT05100017 is a clinical study titled "Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure". Stone disease is a common condition, affecting approximately 9% of Americans in 2007. It causes great morbidity and is also a costly condition, estimated to cost the US healthcare system approximately 3.79 billion dollars in 2007. Ureteroscopy (URS) is the most commonly performed surgical treatment ...

What is the current status of trial NCT05100017?

This trial is currently recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2021-09-30. Estimated completion is 2025-12.

What conditions does trial NCT05100017 study?

This clinical trial studies the following conditions: Kidney Diseases, Nephrolithiasis, Urolithiasis, Kidney Calculi, Ureteral Calculi.

What interventions are being tested in trial NCT05100017?

The interventions under investigation include: Methocarbamol (DRUG), Oxybutynin (DRUG).

Who is sponsoring clinical trial NCT05100017?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05100017 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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