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OpenTrials
Completed

NCT Number: NCT05211193

Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).

Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.

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Key information

Conditions

Overactive Bladder (OAB) Failed Any OAB Pharmacotherapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

MUDr. Michal Rejchrt

Příbram, Czech, 261 01, Czechia

About this study

Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 18 years or older, inclusive
  • Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms
  • Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months
  • Treatment Satisfaction VAS <50
  • Ability to understand and sign ICF
  • Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests
  • Subject agreed not to participate in another research study from the time of screening until the final study visit
  • Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit

Exclusion criteria

  • Prior treatment with botulotoxin for OAB
  • Previous pharmacotherapy for OAB if >12 months ago
  • Urinary retention with post void residual > 150ml
  • Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs
  • History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant

Treatment and study plan

eTNM delivered by URIS I nerve stimulation device

Device

eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1-42.

Primary outcomes

  1. Change of severe urgency episodes

    Time frame: baseline and end of study (6weeks treatment)

    The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation.

Sponsors and collaborators

Lead sponsor

Stimvia s.r.o.

Industry

Registry information

Official study title

Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2022
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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