Vaginal Stent for Constriction, Pathologic

Phase-Based Estimates
1
Effectiveness
1
Safety
Baylor College of Medicine, Houston, TX
Constriction, Pathologic+1 More
Vaginal Stent - Device
Eligibility
< 65
Female
Eligible conditions
Constriction, Pathologic

Study Summary

This study is evaluating whether a new vaginal stent may help improve comfort and retention for women who have undergone surgery.

See full description

Eligible Conditions

  • Constriction, Pathologic
  • Vaginal Stricture

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Vaginal Stent will improve 2 primary outcomes and 2 secondary outcomes in patients with Constriction, Pathologic. Measurement will happen over the course of 24 hours - 4 weeks from stent placement.

Year 1
Number of participants who develop vaginal stenosis
Number of required subsequent medical interventions
Week 4
Number of participants able to retain vaginal stent
Number of participants reporting vaginal stent as comfortable.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

4 Treatment Groups

No Control Group
Pediatric participants: post vaginal surgery

This trial requires 40 total participants across 4 different treatment groups

This trial involves 4 different treatments. Vaginal Stent is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Pediatric participants: post vaginal surgery
Device
Pediatric participants will wear the vaginal stent for 2 weeks after undergoing vaginal surgery.
Adult participants: post vaginal brachytherapy
Device
Adult participants undergoing vaginal brachytherapy for cancer treatment will wear the stent for 2 weeks, be evaluated by a physician, and wear the stent for an additional 2 weeks.
Healthy participants: chronic
Device
Healthy participants will wear the stent chosen to be the more comfortable for 2 weeks without removal.
Healthy participants: acuteHealthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year from stent placement
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year from stent placement for reporting.

Who is running the study

Principal Investigator
J. H.
Prof. Julie Hakim, Assistant Professor
Baylor College of Medicine

Closest Location

Baylor College of Medicine - Houston, TX

Eligibility Criteria

This trial is for female patients aged 65 and younger. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Not pregnant
participant consent or parent/guardian consent & participant assent
Understand requirements of study
Undergoing vaginal brachytherapy
Agree to abide by study restrictions
Able to travel to Houston
Understand English or Spanish to a 5th grade level
No prior history of vaginal surgery or radiation
Undergoing vaginal surgery

Patient Q&A Section

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

Can constriction, pathologic be cured?

Add answer

The histopathologic findings for constriction, pathologic suggest that constriction is not a benign condition and consequently, there is a need for a surgical cure and for a medical treatment. The surgeon should treat constriction using local anesthesia and close follow-up of the patient. Constriction, pathologic may require a procedure to relieve the pressure and is probably justified in cases of acute decompression. In addition, the surgeon should take precaution whenever possible and avoid any unnecessary operations.

Unverified Answer

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

Add answer

About 4% (913,990 persons) of men and 15% (1,931,060 persons) of women die of constriction, pathologic. These estimates are somewhat higher than those for all causes of death and suggest that constriction, pathologic is not a negligible cause of death. Deaths caused by constriction, pathologic may make contributions to the rates of suicide, accidental injury, and the overall mortality that would be expected if deaths caused by suicide and accidental deaths were excluded.

Unverified Answer

What are the signs of constriction, pathologic?

Add answer

There is often a constricting lesion arising from a subepithelial space on the surface of an internal organ. The space is lined with mesenchyma. An intact capsule from a benign lesion of the same shape as the original lesion may be seen. If the lesion is not benign, it is often the first of a series of adenomas or carcinoma of the same shape and location. In those cases where the original lesion is not benign, it is often at a different site, and the capsule of the benign lesion surrounds the lesion in a way different from that of the original lesion.

Unverified Answer

What causes constriction, pathologic?

Add answer

Atherosclerotic lesions in the aorta involve intimal thickening caused by vasodilatation of the vessel wall. The lesions form as a result of the accumulation of collagen around the vessel lumen.

Unverified Answer

What are common treatments for constriction, pathologic?

Add answer

This is the first study to describe treatments for constriction, pathologic onlay/sublay, and anastomotic fistulae. Most people undergoing treatment were treated with constricted closure or no closure.

Unverified Answer

What is constriction, pathologic?

Add answer

Constriction, pathologic, or the constriction-pathologic syndrome, is a broad array of medical problems spanning every anatomical and functional organ, and even specific symptoms and signs can be in and of themselves a diagnosis of constriction. As a pathophysiologic basis, it emphasizes the presence of physiological disturbances in all tissue layers which can influence the mechanics and elasticity of tissue. The constellation of symptoms and their relationship to specific bodily processes was outlined by Wiggers.

Unverified Answer

What does vaginal stent usually treat?

Add answer

The use of vaginal stents is often advocated in the last decade. However, the indications for this procedure are not always justified. We found the following guidelines in the literature: 1. Patients with vaginal obstruction should have surgery; 2. Patients with intrauterine adhesions should have surgery, especially in case of severe prolapse, or stents should be placed in patients with large fistulas, or 3. Women with anorectal fistulas will do well if adequate stenting is used.

Unverified Answer

What are the latest developments in vaginal stent for therapeutic use?

Add answer

Vaginal stents have been widely used since the 1990s as an alternative mode of treatment for pathological conditions of the vagina. In spite of the wide body of literature on these devices and reports on their clinical applicability, vaginal stents have not gained widespread acceptance and their usage is constrained. This article provides a comprehensive review of available literature on vaginal stents and their clinical applicability. It also offers up-to-date reviews related to vaginal stents from an evidence-based perspective to guide women in selecting the best clinical applicability.

Unverified Answer

Is vaginal stent safe for people?

Add answer

The use of vaginal stents in women with stress urinary incontinence is safe. More people prefer stent to conservative therapy. However, the high risk of stent migration warrants further study and caution with regard to stent removal, particularly if symptoms improves with stent removal.

Unverified Answer

How serious can constriction, pathologic be?

Add answer

When constriction causes severe discomfort, severe physical limitations such as pain, edema, and reduced functional abilities are common; however, constriction without significant discomfort is more likely to be overlooked even by experienced physicians.

Unverified Answer

What is the average age someone gets constriction, pathologic?

Add answer

The average age a patient is diagnosed with constriction, pathologic in South Korea is 71-years-old. It is a little bit older than the average age when patients begin to have constriction, pathologic. The reason for this phenomenon is probably because more women are diagnosed with constriction, pathologic as they are more often diagnosed with this disease. This phenomenon seems to be more common in the female sex.

Unverified Answer

What is the latest research for constriction, pathologic?

Add answer

A small number of new research studies have been published since the last review. The largest body of study was published two years ago by Cordero et al. from the Mayo Clinic in Minnesota: The authors examined the utility of MRI and CSF-based biomarkers to assist clinical diagnosis of constrictive pericarditis. While some findings from previously published studies were reproduced, the authors found there was insufficient evidence from any of the published studies to recommend clinical utility of biomarkers. The authors conclude that the role of biomarkers in clinical diagnosis of constrictive pericarditis is not robust or reliable enough to advise clinical decision making based on the available evidence.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Constriction, Pathologic by sharing your contact details with the study coordinator.