Urotronic Drug Coated Balloon (DCB) for Stricture Urethra

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Libra Medical Inc, Brooklyn Park, MN
Stricture Urethra+1 More
Urotronic Drug Coated Balloon (DCB) - Device
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a new drug called DCB is safe and effective for treating people with chronic migraine.

See full description

Eligible Conditions

  • Stricture Urethra

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Urotronic Drug Coated Balloon (DCB) will improve 1 primary outcome and 1 secondary outcome in patients with Stricture Urethra. Measurement will happen over the course of 90 days post-procedure.

90 days post-procedure
Rate of Treatment Related Serious Complication
Stricture Recurrence Rate

Trial Safety

Trial Design

1 Treatment Group

DCB Treatment
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Urotronic Drug Coated Balloon (DCB) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

DCB Treatment
Device
Stricture patients treated by DCB

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days post-procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days post-procedure for reporting.

Closest Location

Libra Medical Inc - Brooklyn Park, MN

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Stricture Urethra or the other condition listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
in greatest dimension, may be treated by urethral dilation and observation A single lesion that is no more than 2 cm in diameter in the anterior urethra or at the bladder neck may be treated by dilation and observation. show original
The individual has had one to three prior diagnoses and treatments for the same stricture, including self-catheterization, but no prior urethroplasty. show original
The symptoms of a stricture can include frequent urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, and recurrent UTI's. show original
The text is about male subjects who are at least 18 years old. show original
may be required before perineal urethrostomy is considered show original
An IPSS score of 13 or higher is associated with a bleak long-term outlook show original
The lumen diameter is less than 12 millimeters when measured by a urethrogram. show original
The text says that the person is able to complete the questionnaire without help. show original
Qmax is less than 10 ml/sec. show original

Patient Q&A Section

What causes constriction, pathologic?

"The pathology of constrictive periurethral fibrosis, which is typically seen in the postpartum uterine period and may coincide with the onset of menopausal symptoms, will lead to constrictive changes in the uterine vasculature. The pathogenesis of uterine vessel constriction is not well understood." - Anonymous Online Contributor

Unverified Answer

What are common treatments for constriction, pathologic?

"There are many techniques that can be applied for constriction, including surgical, nonsurgical, and nonsurgical and conservative approaches. Minimally invasive surgical procedures are an intriguing potential future alternative to conventional surgical approaches." - Anonymous Online Contributor

Unverified Answer

Can constriction, pathologic be cured?

"(1) All constrictive lesions have unpredictable healing, even in cases with no residual symptoms; (2) constrictive lesions are not always asymptomatic, and symptoms may vary from patient to patient; (3) most cases of symptomatic constrictive lesions will resolve spontaneously or spontaneously in a short time; and (4) most cases of asymptomatic constrictive lesions may regress spontaneously. Therefore, cure cannot be accomplished by constrictive procedures, because the unpredictable, unpredictable, and unpredictable healing have to be accounted for." - Anonymous Online Contributor

Unverified Answer

What is constriction, pathologic?

"The definition of constriction, pathologic, is important for the diagnosis and treatment of constriction of the esophagus due to chronic diseases, especially diabetes, in the general population, and especially in children, because it determines patient presentation and treatments. As a result, it is a simple and easy-to-detect finding." - Anonymous Online Contributor

Unverified Answer

What are the signs of constriction, pathologic?

"Signs of constriction were often nonspecific, including lethargy, anhedonia (loss of interest in activities for which the patient is highly motivated), dysphoria, and apathy (loss of the capacity to feel pleasure and pleasure). The hallmark of constriction, ileus and ileoscopy, are indications of the chronicity of the disorder, and are usually not present." - Anonymous Online Contributor

Unverified Answer

How many people get constriction, pathologic a year in the United States?

"The disease of constriction, pathologic will have a nearly 10-fold increase in diagnosis over the next three decades in the United States. It is estimated that 15 people per year will be diagnosed with constriction, pathologic over the same period." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating constriction, pathologic?

"There is no evidence suggesting that any treatments can improve the quality of life of patients with constriction, pathologic. More than half of the patients would like to receive such treatment to relieve their distress, with the exception of stoma closure. Patients with constriction, pathologic are able to live at many levels of their quality of life. There is a need to develop a holistic approach of treatments for patients presenting constriction, pathologic." - Anonymous Online Contributor

Unverified Answer

Is urotronic drug coated balloon (dcb) typically used in combination with any other treatments?

"Data from a recent study has shown that when combined with PTA, the DCB with anti-platelet coated surface has significantly fewer and less severe adverse events than with unfurter PTA and is more effective in reducing pain without causing complications. Use of DCB in combination with PTA could be a better alternative in the treatment of the arteries of patients with carotid stenosis. Additional studies may be necessary to further examine this use." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of urotronic drug coated balloon (dcb)?

"It is not uncommon for urotronic coating agents to be associated with the side effect of burning pain on the urethra, lower urinary tract, or renal artery. While burn pain has been reported to be transient, it may be severe in some patients. Patients at risk of serious burns during ureteral deployment of ureteral stent are at an increased risk for this common complication. Patients undergoing this procedure before renal artery involvement has an increased risk of renal arterial thrombosis as well." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving urotronic drug coated balloon (dcb)?

"[Previous dcb studies have led to new research in the use of Dcb for the treatment of achalasia] (https://www.clinicaltrials.gov/ct2/show/NCT01645487?). [The studies have shown that use of urotronic Dcb is an effective new drug for treating achalasia, with improvement in symptoms seen after treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of constriction, pathologic?

"The most common cause of constriction, pathologic is fibrosis and scarring due to vascular damage and chronic inflammatory reaction. These vascular scars are more frequently observed in the context of pathologies associated with a low BMI since the vessels are at a higher risk of intimal hyperplasia due to a lack of proper stimulation of vascular endothelial growth factor (VEGF)." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in urotronic drug coated balloon (dcb) for therapeutic use?

"The newest development of DCB is with novel DCB coated with sertoli cell protein and spermine. These compounds act as 'coadjuvers' that help improve balloon's retention leading to sustained durations of thermal balloon application that may afford longer periods of vessel cooling leading to better clinical outcomes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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