Urinary RetentionNCT04000763
Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention
A study testing superficial peroneal nerve stimulation in people with Urinary Retention and Urinary Bladder, Underactive, run by Christopher J Chermansky, MD at 1 site in United States.
Trial summary
Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling suprapubic catheter. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Urinary Retention, Urinary Bladder, Underactive
- What is being tested?
- superficial peroneal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2019to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- 18 years of age and older
- Clinically diagnoses as non-obstructive urinary retention
- Post Void Residual of 300 mL or greater
- Currently using daily self-catheterization to empty the bladder
- Capable of using the toilet independently without difficulty
- Capable and willing to follow all study-related procedures
Who cannot join
- Neurologic diagnosis (including diabetes mellitus)
- Surgery within one year of screening for urinary outlet obstruction
- Pregnant or planning to become pregnant during study duration
- OnabotulinumtoxiA use in bladder or pelvic floor muscles with the past year
- Pacemaker or implantable defibrillator
- Current Urinary tract or vaginal infections
Show all 11Show fewer
- Current Interstim use
- Current Percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation (TENS) use in pelvis or back or legs
- Investigational drug/ device therapy with the past 4 weeks,
- Participation in any clinical investigation involving or impacting gynecologic or urinary function with the past 4 weeks,
- Previous surgery of or damage to the foot or nerves in the foot and leg.
Trial locations and contacts
1 site in 1 country.
About this study
Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling suprapubic catheter. Currently an effective drug for non-obstructive urinary retention does not exist. It is a therapeutic challenge for clinicians to successfully treat non-obstructive urinary retention. Sacral neuromodulation has been approved by the FDA since 1999 to treat non-obstructive urinary retention. It achieves >50% improvement in bladder emptying (reducing the frequency of self-catheterization or increasing voided volume) in just over half of the patients. Sacral neuromodulation requires surgical implantation of a stimulator and a lead with 4 electrodes. The surgery and implant are invasive and expensive, preventing a broad application of this effective therapy to many non-obstructive urinary retention patients. The goal of this study is to develop a novel non-invasive neuromodulation therapy for non-obstructive urinary retention as an alternative. Specifically, the investigators will explore the possibility to translate into humans a recent discovery in cats of an excitatory reflex from the superficial peroneal nerve to the bladder to treat non-obstructive urinary retention. Therefore, in this study the investigators propose to develop a non-invasive, transcutaneous neuromodulation therapy for non-obstructive urinary retention that can be administered at home.
Read the detailed description
Hypothesis: Electrical stimulation of the superficial peroneal nerve using transcutaneous skin electrodes attached on the dorsal foot can treat non-obstructive urinary retention either by enhancing bladder sensation thereby reducing bladder volume needed for initiating voiding and/or by enhancing bladder contraction, thereby increasing voiding efficiency and reducing post-void residual (PVR) volume.
Rationale: The investigators conducted preliminary studies in cats that have demonstrated an excitatory reflex to the bladder elicited by stimulation of afferent axons in the superficial peroneal nerve. Activating this excitatory reflex in cats reduced bladder capacity (the minimal volume for initiating a micturition reflex), enhanced bladder contractions and overcame bladder inhibition emanating from somatic (tibial) afferent activation. Since the superficial peroneal nerve innervates the dorsal skin of the foot in humans, it can be stimulated non-invasively by skin surface electrodes. Transcutaneous stimulation of this nerve, should it prove efficacious, would likely be more acceptable to patients with non-obstructive urinary retention (NOUR) than invasive sacral neuromodulation therapy. Therefore, in this study, the investigators propose to test the superficial peroneal nerve neuromodulation in non-obstructive urinary retention patients.
Specific Aim: Determine the efficacy of superficial peroneal nerve stimulation (SPNS) in the treatment of patients with non-obstructive urinary retention using skin electrodes attached to the dorsal surface of the foot.
Rationale: Based on a preliminary discovery in cats, the investigators propose to further investigate the effect of superficial peroneal nerve stimulation (SPNS) on voiding efficiency, post-void residual (PVR) volume, and bladder capacity (voided volume + post-void residual) in patients with non-obstructive urinary retention. A reduced bladder capacity indicates more normal bladder filling sensations, thereby allowing voiding at more normal volumes. The investigators plan to test superficial peroneal nerve stimulation in 10 non-obstructive urinary retention patients by collecting voiding diary during a 3-week period. Baseline voiding diary will be collected during the first week before superficial peroneal nerve stimulation initiation. During the second week, superficial peroneal nerve stimulation will be administered to each patient for 3 hours/day before sleep and it will also be administered immediately prior and throughout each void. The 3-hour stimulation is designed to modulate bladder sensory pathways to enhance bladder sensation, thereby reducing the bladder volume required to initiate voiding. The acute stimulation during each void is designed to enhance bladder contraction, thereby increasing voiding efficiency and reducing post-void residual. During the third week, superficial peroneal nerve stimulation will not be applied, and a voiding diary will be collected to determine any post-stimulation effect. Since the superficial peroneal nerve is a cutaneous nerve innervating the skin of the dorsal foot, superficial peroneal nerve stimulation will be applied non-invasively by attaching skin surface electrodes to the dorsal side of the foot.
- Conditions
- Urinary Retention, Urinary Bladder, Underactive
- Being tested
- superficial peroneal nerve stimulation
- Keywords
- Bladder
- Medical subject headings
- Urinary Retention, Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial peroneal nerve stimulationDevice
A commercially available FDA-approved transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes will be used to stimulate the foot. The electrodes will be attached to the dorsal surface of the foot and a sock will be placed over the foot to prevent detachment of the electrodes. Based on our animal studies, foot stimulation parameters of 2 Hz frequency and 0.2 ms pulse width will be used at the maximal intensity comfortable for each patient. It is expected that superficial peroneal nerve stimulation in patients can increase bladder sensation so that micturition can be initiated at a small bladder volume, or it can initiate bladder contraction at a small bladder volume and enhance the contraction or prolong the duration of contraction. Any of these excitatory effects, if occurs in human patients, will certainly improve the condition of non-obstructive urinary retention.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Nerve Stimulator(TENS) | Experimental | 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. Receives: Device: superficial peroneal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of voids per subject in 24 hours.
Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation.
Measured: 3 weeks
Number of catheterizations per subject in 24 hours.
Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation.
Measured: 3 weeks
Volume of urine per void.
Calculated in millimeters both before and after peroneal nerve stimulation.
Measured: 3 weeks
Catheterized Post Void Residual volume
Calculated in millimeters both before and after peroneal nerve stimulation.
Measured: 3 weeks
Bladder Voiding efficiency
Pre voiding and post voiding ratio that reflects bladder contractility
Measured: 3 weeks
Bladder capacity
Calculated by adding the voided volume to the post residual catheterization volume, in milliliters
Measured: 3 weeks
Secondary outcomes (3)
Efficacy of Foot Stimulation
Difference in millimeters of bladder emptying capacity from week 2 to baseline
Measured: 2 weeks
Efficacy of Foot Stimulation
Difference in millimeters of bladder emptying capacity from week 3 to baseline
Measured: 3 weeks
Post-stimulation effect
Difference in millimeters of bladder emptying capacity from week 2 to week 3.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start20 Dec 2019
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All experiments proposed in this grant application will be performed in female non-obstructive urinary retention patients. We chose not to study male patients in this study given the need to exclude bladder outlet obstruction from benign prostatic hyperplasia (BPH), an evaluation that is invasive and costly.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher J Chermansky, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor-investigator, Christopher J Chermansky, MD, University of Pittsburgh
- Investigators
- Christopher Chermansky, MD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000763
- Sponsor's protocol ID
- STUDY19010062
- Status last verified
- Mar 2025
- First submitted
- 23 May 2019
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data and methods will be shared with other investigators upon signed data use agreements and assurance of Institutional Review Board approval.
Publications
26872574
Juszczak K, Drewa T. Pharmacotherapy in detrusor underactivity: A new challenge for urologists and pharmacologists (from lab to clinic). Pharmacol Rep. 2016 Aug;68(4):703-6. doi: 10.1016/j.pharep.2016.03.007. Epub 2016 Mar 19.
PubMed 27110877Kessler TM, Fowler CJ. Sacral neuromodulation for urinary retention. Nat Clin Pract Urol. 2008 Dec;5(12):657-66. doi: 10.1038/ncpuro1251. Epub 2008 Nov 11.
PubMed 19002127De Ridder D, Ost D, Bruyninckx F. The presence of Fowler's syndrome predicts successful long-term outcome of sacral nerve stimulation in women with urinary retention. Eur Urol. 2007 Jan;51(1):229-33; discussion 233-4. doi: 10.1016/j.eururo.2006.06.031. Epub 2006 Jul 10.
PubMed 16860462Faraj K, Doo F, Boura J, Vereecke A, Chancellor MB. A cross-sectional study in the USA of the epidemiology and quality of life of underactive bladder symptoms. Int Urol Nephrol. 2016 Nov;48(11):1797-1802. doi: 10.1007/s11255-016-1382-0. Epub 2016 Jul 29.
PubMed 27473156Abarbanel J, Marcus EL. Impaired detrusor contractility in community-dwelling elderly presenting with lower urinary tract symptoms. Urology. 2007 Mar;69(3):436-40. doi: 10.1016/j.urology.2006.11.019.
PubMed 17382138Goodwin RJ, Swinn MJ, Fowler CJ. The neurophysiology of urinary retention in young women and its treatment by neuromodulation. World J Urol. 1998;16(5):305-7. doi: 10.1007/s003450050072.
PubMed 9833308Jonas U, Fowler CJ, Chancellor MB, Elhilali MM, Fall M, Gajewski JB, Grunewald V, Hassouna MM, Hombergh U, Janknegt R, van Kerrebroeck PE, Lylcklama a Nijeholt AA, Siegel SW, Schmidt RA. Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation. J Urol. 2001 Jan;165(1):15-9. doi: 10.1097/00005392-200101000-00004.
PubMed 11125353Yu M, Uy J, Jiang X, Li X, Jones C, Shen B, Wang J, Roppolo JR, de Groat WC, Tai C. An excitatory reflex from the superficial peroneal nerve to the bladder in cats. Am J Physiol Renal Physiol. 2017 Nov 1;313(5):F1161-F1168. doi: 10.1152/ajprenal.00265.2017. Epub 2017 Aug 30.
PubMed 28855188Tai C, Shen B, Chen M, Wang J, Roppolo JR, de Groat WC. Prolonged poststimulation inhibition of bladder activity induced by tibial nerve stimulation in cats. Am J Physiol Renal Physiol. 2011 Feb;300(2):F385-92. doi: 10.1152/ajprenal.00526.2010. Epub 2010 Nov 24.
PubMed 21106856
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention
- ClinicalTrials.gov ID
- NCT04000763
- Acronym / sponsor ID
- STUDY19010062
- Conditions
- Urinary Retention, Urinary Bladder, Underactive
- Keywords
- Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Christopher J Chermansky, MDUniversity, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, University of North Carolina, Chapel Hill
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling suprapubic catheter. Currently an effective drug for non-obstructive urinary retention does not exist. It is a therapeutic challenge for clinicians to successfully treat non-obstructive urinary retention. Sacral neuromodulation has been approved by the FDA since 1999 to treat non-obstructive urinary retention. It achieves >50% improvement in bladder emptying (reducing the frequency of self-catheterization or increasing voided volume) in just over half of the patients. Sacral neuromodulation requires surgical implantation of a stimulator and a lead with 4 electrodes. The surgery and implant are invasive and expensive, preventing a broad application of this effective therapy to many non-obstructive urinary retention patients. The goal of this study is to develop a novel non-invasive neuromodulation therapy for non-obstructive urinary retention as an alternative. Specifically, the investigators will explore the possibility to translate into humans a recent discovery in cats of an excitatory reflex from the superficial peroneal nerve to the bladder to treat non-obstructive urinary retention. Therefore, in this study the investigators propose to develop a non-invasive, transcutaneous neuromodulation therapy for non-obstructive urinary retention that can be administered at home.
Detailed description
Hypothesis: Electrical stimulation of the superficial peroneal nerve using transcutaneous skin electrodes attached on the dorsal foot can treat non-obstructive urinary retention either by enhancing bladder sensation thereby reducing bladder volume needed for initiating voiding and/or by enhancing bladder contraction, thereby increasing voiding efficiency and reducing post-void residual (PVR) volume.
Rationale: The investigators conducted preliminary studies in cats that have demonstrated an excitatory reflex to the bladder elicited by stimulation of afferent axons in the superficial peroneal nerve. Activating this excitatory reflex in cats reduced bladder capacity (the minimal volume for initiating a micturition reflex), enhanced bladder contractions and overcame bladder inhibition emanating from somatic (tibial) afferent activation. Since the superficial peroneal nerve innervates the dorsal skin of the foot in humans, it can be stimulated non-invasively by skin surface electrodes. Transcutaneous stimulation of this nerve, should it prove efficacious, would likely be more acceptable to patients with non-obstructive urinary retention (NOUR) than invasive sacral neuromodulation therapy. Therefore, in this study, the investigators propose to test the superficial peroneal nerve neuromodulation in non-obstructive urinary retention patients.
Specific Aim: Determine the efficacy of superficial peroneal nerve stimulation (SPNS) in the treatment of patients with non-obstructive urinary retention using skin electrodes attached to the dorsal surface of the foot.
Rationale: Based on a preliminary discovery in cats, the investigators propose to further investigate the effect of superficial peroneal nerve stimulation (SPNS) on voiding efficiency, post-void residual (PVR) volume, and bladder capacity (voided volume + post-void residual) in patients with non-obstructive urinary retention. A reduced bladder capacity indicates more normal bladder filling sensations, thereby allowing voiding at more normal volumes. The investigators plan to test superficial peroneal nerve stimulation in 10 non-obstructive urinary retention patients by collecting voiding diary during a 3-week period. Baseline voiding diary will be collected during the first week before superficial peroneal nerve stimulation initiation. During the second week, superficial peroneal nerve stimulation will be administered to each patient for 3 hours/day before sleep and it will also be administered immediately prior and throughout each void. The 3-hour stimulation is designed to modulate bladder sensory pathways to enhance bladder sensation, thereby reducing the bladder volume required to initiate voiding. The acute stimulation during each void is designed to enhance bladder contraction, thereby increasing voiding efficiency and reducing post-void residual. During the third week, superficial peroneal nerve stimulation will not be applied, and a voiding diary will be collected to determine any post-stimulation effect. Since the superficial peroneal nerve is a cutaneous nerve innervating the skin of the dorsal foot, superficial peroneal nerve stimulation will be applied non-invasively by attaching skin surface electrodes to the dorsal side of the foot.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All experiments proposed in this grant application will be performed in female non-obstructive urinary retention patients. We chose not to study male patients in this study given the need to exclude bladder outlet obstruction from benign prostatic hyperplasia (BPH), an evaluation that is invasive and costly.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Nerve Stimulator(TENS) | Experimental | Device: superficial peroneal nerve stimulationAdult 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide informed consent
- 18 years of age and older
- Clinically diagnoses as non-obstructive urinary retention
- Post Void Residual of 300 mL or greater
- Currently using daily self-catheterization to empty the bladder
Key exclusion criteria (11 listed)
- Neurologic diagnosis (including diabetes mellitus)
- Surgery within one year of screening for urinary outlet obstruction
- Pregnant or planning to become pregnant during study duration
- OnabotulinumtoxiA use in bladder or pelvic floor muscles with the past year
- Pacemaker or implantable defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superficial peroneal nerve stimulationA commercially available FDA-approved transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes will be used to stimulate the foot. The electrodes will be attached to the dorsal surface of the foot and a sock will be placed over the foot to prevent detachment of the electrodes. Based on our animal studies, foot stimulation parameters of 2 Hz frequency and 0.2 ms pulse width will be used at the maximal intensity comfortable for each patient. It is expected that superficial peroneal nerve stimulation in patients can increase bladder sensation so that micturition can be initiated at a small bladder volume, or it can initiate bladder contraction at a small bladder volume and enhance the contraction or prolong the duration of contraction. Any of these excitatory effects, if occurs in human patients, will certainly improve the condition of non-obstructive urinary retention. | Device | Transcutaneous Nerve Stimulator(TENS) |
Primary outcome
Number of voids per subject in 24 hours.
Time frame: 3 weeks
Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation.
Number of catheterizations per subject in 24 hours.
Time frame: 3 weeks
Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation.
Volume of urine per void.
Time frame: 3 weeks
Calculated in millimeters both before and after peroneal nerve stimulation.
Catheterized Post Void Residual volume
Time frame: 3 weeks
Calculated in millimeters both before and after peroneal nerve stimulation.
Bladder Voiding efficiency
Time frame: 3 weeks
Pre voiding and post voiding ratio that reflects bladder contractility
Bladder capacity
Time frame: 3 weeks
Calculated by adding the voided volume to the post residual catheterization volume, in milliliters
3 secondary outcomes
Efficacy of Foot Stimulation
Time frame: 2 weeks
Efficacy of Foot Stimulation
Time frame: 3 weeks
Post-stimulation effect
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background26872574
- Background: PubMed 27110877Juszczak K, Drewa T. Pharmacotherapy in detrusor underactivity: A new challenge for urologists and pharmacologists (from lab to clinic). Pharmacol Rep. 2016 Aug;68(4):703-6. doi: 10.1016/j.pharep.2016.03.007. Epub 2016 Mar 19.
- Background: PubMed 19002127Kessler TM, Fowler CJ. Sacral neuromodulation for urinary retention. Nat Clin Pract Urol. 2008 Dec;5(12):657-66. doi: 10.1038/ncpuro1251. Epub 2008 Nov 11.
- Background: PubMed 16860462De Ridder D, Ost D, Bruyninckx F. The presence of Fowler's syndrome predicts successful long-term outcome of sacral nerve stimulation in women with urinary retention. Eur Urol. 2007 Jan;51(1):229-33; discussion 233-4. doi: 10.1016/j.eururo.2006.06.031. Epub 2006 Jul 10.
- Background: PubMed 27473156Faraj K, Doo F, Boura J, Vereecke A, Chancellor MB. A cross-sectional study in the USA of the epidemiology and quality of life of underactive bladder symptoms. Int Urol Nephrol. 2016 Nov;48(11):1797-1802. doi: 10.1007/s11255-016-1382-0. Epub 2016 Jul 29.
- Background: PubMed 17382138Abarbanel J, Marcus EL. Impaired detrusor contractility in community-dwelling elderly presenting with lower urinary tract symptoms. Urology. 2007 Mar;69(3):436-40. doi: 10.1016/j.urology.2006.11.019.
- Background: PubMed 9833308Goodwin RJ, Swinn MJ, Fowler CJ. The neurophysiology of urinary retention in young women and its treatment by neuromodulation. World J Urol. 1998;16(5):305-7. doi: 10.1007/s003450050072.
- Background: PubMed 11125353Jonas U, Fowler CJ, Chancellor MB, Elhilali MM, Fall M, Gajewski JB, Grunewald V, Hassouna MM, Hombergh U, Janknegt R, van Kerrebroeck PE, Lylcklama a Nijeholt AA, Siegel SW, Schmidt RA. Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation. J Urol. 2001 Jan;165(1):15-9. doi: 10.1097/00005392-200101000-00004.
- Background: PubMed 28855188Yu M, Uy J, Jiang X, Li X, Jones C, Shen B, Wang J, Roppolo JR, de Groat WC, Tai C. An excitatory reflex from the superficial peroneal nerve to the bladder in cats. Am J Physiol Renal Physiol. 2017 Nov 1;313(5):F1161-F1168. doi: 10.1152/ajprenal.00265.2017. Epub 2017 Aug 30.
- Background: PubMed 21106856Tai C, Shen B, Chen M, Wang J, Roppolo JR, de Groat WC. Prolonged poststimulation inhibition of bladder activity induced by tibial nerve stimulation in cats. Am J Physiol Renal Physiol. 2011 Feb;300(2):F385-92. doi: 10.1152/ajprenal.00526.2010. Epub 2010 Nov 24.
- Individual participant dataSharing planned: Yes. Data and methods will be shared with other investigators upon signed data use agreements and assurance of Institutional Review Board approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Chermansky, MD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superficial peroneal nerve stimulation in people with Urinary Retention and Urinary Bladder, Underactive, run by Christopher J Chermansky, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of voids per subject in 24 hours. (time frame: 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000763, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.