superficial peroneal nerve stimulation for Urinary Retention

Phase-Based Estimates
1
Effectiveness
1
Safety
UPMC Urology, Pittsburgh, PA
+1 More
superficial peroneal nerve stimulation - Device
Eligibility
18+
Female
Eligible conditions
Urinary Retention

Study Summary

This study is evaluating whether a new device may help reduce the need for catheterization in individuals with non-obstructive urinary retention.

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Eligible Conditions

  • Urinary Retention
  • Hypotonic Bladder
  • Urinary Bladder, Underactive

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether superficial peroneal nerve stimulation will improve 6 primary outcomes and 2 secondary outcomes in patients with Urinary Retention. Measurement will happen over the course of 1 week.

1 week
Post-stimulation effect
3 weeks
Bladder Voiding efficiency
Bladder capacity
Catheterized Post Void Residual volume
Efficacy of Foot Stimulation
Number of catheterizations per subject in 24 hours.
Number of voids per subject in 24 hours.
Volume of urine per void.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Transcutaneous Nerve Stimulator(TENS)

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Superficial Peroneal Nerve Stimulation 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.

Transcutaneous Nerve Stimulator(TENS)
Device
Adult females who have difficulty emptying their bladder due to non-obstructive urinary retention or because of an under-active bladder will be given transcutaneous nerve stimulation (TENS) therapy.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Closest Location

UPMC Urology - Pittsburgh, PA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This means that you must be at least 18 years old in order to purchase alcohol. show original
A person who experiences urinary retention, but does not have an obstruction, is clinically diagnosed as having non-obstructive urinary retention. show original
This text is informing the reader that if they have a Post Void Residual of 300 mL or greater, they should consult a doctor. show original
I am capable and willing to follow all study-related procedures. show original
, the individual will soon have a permanent urinary catheter show original
Able to provide informed consent
The text describes someone who is able to use the toilet without difficulty. show original

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 hypotonic bladder be cured?

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In case of treatment with anticholinic drugs, and even if the symptoms are resolved, recovery may be delayed and may never be complete with the anticholinic drug treatment. Thus, the effectiveness of the pharmacological treatment is limited; the treatment is not entirely efficient and must be continued, or the patient's problems should be carefully re-examined and adjusted. But if the patient hasn't had enough urine at the beginning of the treatment, hypotonic bladder can be cured with more liquids. But if hypotonic bladder occurs only once, its recovery will be complete.

Unverified Answer

What causes hypotonic bladder?

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Decreasing water intake may also decrease glomerular filtration rate to such a degree that it accounts for the loss of urinary salt. This would cause an increase in urine production.

Unverified Answer

What are the signs of hypotonic bladder?

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There are 2 main signs of hypotonic bladder: a lower urinary tract infection, and reduced detrusor tone. Reduced detrusor tone is a significant determinant of detrusor underactivity. Copyright © 2016 John Wiley & Sons, Ltd.

Unverified Answer

How many people get hypotonic bladder a year in the United States?

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This report suggests that 0.2–3.2% of Americans get hypotonic bladder annually. This is because 0.6% of American adults have symptoms of hypotonic bladder (including urinary frequency) at least once a week. 1.6% have symptoms three or more times a week. 1.1% of American adults who have symptoms of urinary frequency three or more times a week must be given a formal diagnosis of hypotonic bladder. Patients with two to three weeks of symptoms have the greatest chance of a formal diagnosis of hypotonic bladder.

Unverified Answer

What is hypotonic bladder?

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Patients with hypotonic bladder showed more symptoms than patients with "normal" bladder (mean total IPSS 17.5 versus 11.5). A high preoperative urine volume correlated to low IPSS. The preoperative IPSS was a good discriminator of postoperative IPSS, however: the difference between preoperative and postoperative IPSS was statistically insignificant (p=0.082), and the IPSS postoperatively correlated to the maximal residual urine volume postoperatively (p=0.026). The IPSS score was the best discriminator among all the variables studied. IPSS can be used preoperatively as a screening test for hypotonic bladder, but the preoperative IPSS score cannot predict the postoperative IPSS.

Unverified Answer

What are common treatments for hypotonic bladder?

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Many patients with hyponatremia have hypovolemic or shock states with a rapid onset and severe symptoms of nausea and vomiting. Appropriate hydration, diuresis, or diuretic treatment are highly recommended.

Unverified Answer

What is the average age someone gets hypotonic bladder?

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This survey provides a baseline value of 6.0% for children younger than 10 years. In contrast to recent studies, this survey shows that <50% of all US-aged children suffer from hypo-contractility of the bladder (2.0% in this study).

Unverified Answer

What is the latest research for hypotonic bladder?

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The most recent literature review is presented. No strong evidence of effect of an investigational agent on the treatment of hypotonic bladder has been demonstrated. Nevertheless, it is important to conduct clinical trials of drugs which may be beneficial for the patient's condition and to report the results in regular updates to the literature.

Unverified Answer

How serious can hypotonic bladder be?

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[Low urine volume can cause severe, permanent damage to the urinary lining of the bladder, which can have a substantial impact on a man's ability to urinate, and on his quality of life]. In some instances, such as [congenital malformations of the bladder, or traumatic rupture of the bladder] hypotonic bladder can be permanent. Men who have a severely hypotonic bladder should take great care during sports activities, and have their urine volumes checked frequently. Treatment for patients with severely hypotonic bladders can be tedious, and may also entail prolonged therapy in order to ensure complete healing of the bladder.

Unverified Answer

Have there been any new discoveries for treating hypotonic bladder?

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The existing treatments are effective to some extent, but it's difficult to treat hypotonic bladder thoroughly because of the side effects caused by treatments. There are still many new discoveries to find for treating hypotonic bladder; such as antioxidants, calcium channel blockers, etc.

Unverified Answer

Has superficial peroneal nerve stimulation proven to be more effective than a placebo?

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In this single center study, our study patients experienced increased resting urinary bladder capacity, and decreased frequency of urgency incontinence. We found the treatment to be a safe and well tolerated adjunctive intervention, and we also found the benefit of treatment sustained over a 1-year period. Recent findings are encouraging, and open new perspectives in managing bladder function and urgency incontinence.

Unverified Answer

How does superficial peroneal nerve stimulation work?

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A superficial PNS procedure in patients with neuropathic bladder symptoms resulted in a significant decline in bladder volume when compared to before PNS procedure. It is postulated that the decreased bladder volume reflects a direct effect on the bladder neurogenic receptors that result in a reduction in detrusor overactivity. Findings from a recent study suggest that PNS in an animal model may provide a potential alternative to conventional bladder therapies particularly as no conventional treatment for neurogenic bladder disorders is [unresponsive or does not exist] and the treatment involves minimal side effects.

Unverified Answer
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