Evidence map›Paper›PMID 34694911›Full record

Trial reportThe Journal of urology2022

Noninvasive, Individualized Cortical Modulation Using Transcranial Rotating Permanent Magnet Stimulator for Voiding Dysfunction in Women with Multiple Sclerosis: A Pilot Trial.

Rose Khavari, Khue Tran, Santosh A Helekar, Zhaoyue Shi, Christof Karmonik, Hamida Rajab, Blessy John, Ali Jalali, Timothy Boone

2 registry-linked trialsOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in The Journal of urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03574610 nacompletednot on this map

Supraspinal Mechanisms Involved in Voiding Dysfunction.

TypeinterventionalSponsorThe Methodist Hospital Research InstituteRan2018 to 2022Enrolled11ConditionsNeurogenic Bladder, Multiple Sclerosis, Voiding DysfunctionArmsTranscranial Rotating Permanent Magnet Stimulator (TRPMS)
NCT06072703 narecruitingnot on this mapstarted 2023, after this paper: background citation

A Randomized, Sham-Controlled Clinical Trial Evaluating Individualized Neuromodulation of Cortical Regions Involved in Neurogenic Overactive Bladder in Multiple Sclerosis

TypeinterventionalSponsorThe Methodist Hospital Research InstituteRan2023 to 2027Enrolled29ConditionsNeurogenic Bladder, Multiple Sclerosis, Overactive BladderArmsMagstim Rapid2 System
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. TRPMS to improve voiding in patients with MS.Nature reviews. Urology · 2022
    Article
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Rose KhavariDepartment of Urology, Houston Methodist Hospital, Houston, Texas.
Khue TranDepartment of Urology, Houston Methodist Hospital, Houston, Texas.
Santosh A HelekarDepartment of Neurosurgery, Houston Methodist Hospital, Houston, Texas.
Zhaoyue ShiTranslational Imaging Center, Houston Methodist Research Institute, Houston, Texas.
Christof KarmonikTranslational Imaging Center, Houston Methodist Research Institute, Houston, Texas.
Hamida RajabDepartment of Urology, Houston Methodist Hospital, Houston, Texas.
Blessy JohnMagnetic Stimulation Device Core Lab, Houston Methodist Research Institute, Houston, Texas.
Ali JalaliDepartment of Neurosurgery, Baylor College of Medicine, Houston Texas.
Timothy BooneDepartment of Urology, Houston Methodist Hospital, Houston, Texas.
Methodist Hospital · USImaging Center · USBaylor College of Medicine · USHouston Methodist · US

Funding

SUPRASPINAL TARGETS IN NEUROGENIC VOIDING DYSFUNCTIONK23DK118209 · NIDDK · METHODIST HOSPITAL RESEARCH INSTITUTE · PI KHAVARI, ROSE · 2018 to 2021
$546k
High-resolution mapping of the human brainstem during continence and micturition: noninvasive in vivo 7 Tesla fMRI studyR03DK126994 · NIDDK · METHODIST HOSPITAL RESEARCH INSTITUTE · PI KHAVARI, ROSE · 2021 to 2022
$242k
NIDDK NIH HHS K23 DK118209NIDDK NIH HHS R03 DK126994
6 · The paper itself

Abstract

purposeVoiding dysfunction (VD) leading to urinary retention is a common neurogenic lower urinary tract symptom in patients with multiple sclerosis (MS). Currently, the only effective management for patients with MS with VD is catheterization. Transcranial Rotating Permanent Magnet Stimulator (TRPMS) is a noninvasive, portable, multifocal neuromodulator that simultaneously modulates multiple cortical regions and the strength of their functional connections. In this pilot trial (ClinicalTrials.gov Identifier: NCT03574610), we investigated the safety and therapeutic effects of TRPMS in modulating brain regions of interest (ROIs) engaged with voiding initiation to improve VD in MS women. MATERIALS AND

methodsTen MS women with VD (having % post-void residual/bladder capacity [%PVR/BC] ≥40% or being in the lower 10th percentile of the Liverpool nomogram) underwent concurrent functional magnetic resonance imaging/urodynamic study (fMRI/UDS) with 3 cycles of bladder filling/emptying, at baseline and post-treatment. Predetermined ROIs and their activations at voiding initiation were identified on patients' baseline fMRI/UDS scans, corresponding to microstimulator placement. Patients received 10 consecutive 40-minute treatment sessions. Brain activation group analysis, noninstrumented uroflow, and validated questionnaires were compared at baseline and post-treatment.

resultsNo treatment-related adverse effects were reported. Post-treatment, patients showed significantly increased activation in regions known to be involved at voiding initiation in healthy subjects. %PVR/BC significantly decreased. Significant improvement of bladder emptying symptoms were reported by patients via validated questionnaires.

conclusionsBoth neuroimaging and clinical data suggested TRPMS effectively and safely modulated brain regions that are involved in the voiding phase of the micturition cycle, leading to clinical improvements in bladder emptying in patients with MS.

Indexed as

AdultAgedFemaleHumansMagnetic Resonance ImagingMiddle AgedMultiple SclerosisNeuroimagingPilot ProjectsTranscranial Magnetic StimulationUrinary Bladder, NeurogenicUrodynamicsmagnetic resonance imagingmultiple sclerosis

Identifiers

PMID34694911
PMCPMC9724016
OpenAlexW3210895355

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.