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Studies

Observational Recruiting

NCT07205445 on ClinicalTrials.gov

Tensi+ European Post-Market Clinical Follow-Up

  • Sponsor: Stimuli Technology
  • Enrollment: 500 (Estimated)
  • Study start: 2025-02-27 (Actual)
  • Primary completion: 2028-10-01 (Estimated)
  • Study completion: 2028-10-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. Preliminary studies have shown a favorable safety and efficacy profile. The goal of the present registry is to collect data among an important number of patients to assess the efficacy, safety and potential predictive factors of success in a current clinical setting over a total period of 1 year.

Conditions

  • Overactive Bladder

Intervention / Treatment

  • Device: Tensi+

Primary Outcome Measures

  • Subjective improvement (3 and 12 months)
    The Patient Global Impression of Improvement (PGI-I) uses a 7-point scale, where post-treatment condition is rated as follows: 1. = Very much better 2. = Much better 3. = A little better 4. = No change 5. = A little worse 6. = Much worse 7. = Very much worse. For analysis, patients with a PGI-I score of 1, 2, or 3 are typically considered responders, reflecting meaningful improvement.

Countries

France, Italy, United Kingdom

Locations and Investigators

  • HFME - Hospices Civils de Lyon, Bron, France (Recruiting)
    • Gery Lamblin, MD, PhD
  • CHU de Rennes, Rennes, France (Recruiting)
    • Benoît Peyronnet, MD, PhD
  • CHU de Rennes, Rennes, France (Recruiting)
    • Juan Penafiel, MD
  • CHU de Rouen - Hôpital Charles Nicolle, Rouen, France (Recruiting)
    • Jean-Nicolas Cornu, MD, PhD
  • Nuova Villa Esther, Avellino, Italy (Recruiting)
    • Luca Cindolo, MD, PhD
  • Azienda Ospedaliero-Universitaria Careggi, Florence, Italy (Not yet recruiting)
    • Stefania Musco, MD, PhD
  • Hesperia Hospital, Modena, Italy (Recruiting)
    • Luca Cindolo, MD, PhD
  • Santa Maria la Gruccia Hospital, Montevarchi, Italy (Recruiting)
    • Marilena Gubbiotti, MD, PhD
  • Policlinico Tor Vergata, Roma, Italy (Not yet recruiting)
    • Enrico Finazzi Agrò, MD, PhD
  • Casa di Cura Villa Stuart, Roma, Italy (Recruiting)
    • Luca Cindolo, MD, PhD
  • Villa Salaria Hospital, Roma, Italy (Recruiting)
    • Luca Cindolo, MD, PhD
  • Azienda Ospedaliero Universitaria Sant'Andrea, Roma, Italy (Recruiting)
    • Cosimo De Nunzio, MD, PhD
  • Azienda Ospedaliero Universitaria Sant'Andrea, Roma, Italy (Recruiting)
    • Antonio Nacchia, MD, PhD
  • Clinica Nuova Villa Claudia, Roma, Italy (Recruiting)
    • Luca Cindolo, MD, PhD
  • Bristol Urological Institute, Bristol, United Kingdom (Not yet recruiting)
    • Hashim Hashim, MD, PhD
  • Addenbrooke's Hospital, Cambridge University Hospital Trust, Cambridge, United Kingdom (Not yet recruiting)
    • Suzanne Biers, MD
  • University College Hospital London, London, United Kingdom (Not yet recruiting)
    • Mahreen Pakzad, MD