Evidence map›Paper›PMID 38958641›Full record

Trial reportThe journal of spinal cord medicine2025

Transcutaneous neuromodulation versus oxybutynin for neurogenic detrusor overactivity in persons with spinal cord injury: A randomized, investigator blinded, parallel group, non-inferiority controlled trial.

Samantak Sahu, Srikumar Venkataraman, Asem Rangita Chanu, U Singh

Abstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in The journal of spinal cord medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Samantak SahuDepartment of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Srikumar VenkataramanDepartment of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi, India.ORCID 0000-0002-5367-6288
Asem Rangita ChanuDepartment of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi, India.
U SinghDepartment of Physical Medicine and Rehabilitation, Mahatma Gandhi Medical College and Hospitals, Jaipur, Rajasthan, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designThis study is a randomized, investigator-blinded, controlled trial with a non-inferiority design.

objectiveTo investigate the effectiveness of neuromodulation by transcutaneous electrical stimulation of the somatic afferent nerves of the foot in neurogenic detrusor overactivity (NDO) in persons with spinal cord injury (SCI) and compare its effectiveness with oral oxybutynin.

settingThe study was conducted in a rehabilitation in-patient ward of a tertiary care hospital.

methodsTwenty-nine persons with SCI with NDO, either sex, aged 18 years and above were randomized into two groups, one group receiving oral oxybutynin (5 mg thrice a day for two weeks) and the other transcutaneous electrical stimulation (5 Hz, 200 µs pulse, biphasic, amplitude up to 60 mA, 30 min/day for two weeks). Bladder capacity was evaluated by clinical bladder evaluation (i.e. bladder capacity measured by adding leak volume, voiding volume if any, and post-void residue using a catheter) and cystometric bladder capacity by one-channel cystometry. Maximum cystometric pressure was evaluated by one-channel water cystometry. Data were analyzed with Fisher's Exact, t-test, and Wilcoxon rank sum tests.

resultsBladder capacity improved significantly in the oxybutynin and neuromodulation groups as measured by one-channel water cystometry (136 ml vs. 120.57 ml) and clinical evaluation (138.93 ml vs. 112 ml). The increase in the neuromodulation group achieved the pre-decided non-inferiority margin of 30 ml over the oxybutynin group when measured by one-channel water cystometry but not by clinical evaluation. Maximum cystometric pressure did not significantly improve in either group when compared with the baseline.

conclusionTranscutaneous neuromodulation and oxybutynin effectively increased bladder capacity in persons with SCI with NDO. Neuromodulation by once-a-day transcutaneous electrical stimulation was non-inferior to thrice-a-day oxybutynin when evaluated by one-channel water cystometry.

Indexed as

Mandelic AcidsMuscarinic AntagonistsSpinal Cord InjuriesTranscutaneous Electric Nerve StimulationUrinary Bladder, NeurogenicUrinary Bladder, OveractiveUrological AgentsAdultAgedFemaleHumansMaleMiddle AgedSingle-Blind MethodTreatment OutcomeMandelic AcidsMuscarinic AntagonistsoxybutyninUrological AgentsMuscarinic antagonistOveractive detrusorSpinal cord diseasesTENS

Identifiers

PMID38958641
PMCPMC12499535

What OpenQuestion holds

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Registered trials

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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.