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Urodynamic Studies: Uroflowmetry

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Related Experiment Videos

Randomized, Sham-Controlled, Double-Blind Trial of the Intibia System in Urge Urinary Incontinence: Quality-of-Life

Jeffrey Mangel1, Kevin Miller2, Ty Erickson3

  • 1Division of Urogynecology and Reconstructive Pelvic Surgery, MetroHealth Medical Center, Case Western Reserve University School of Medicine, MetroHealth Medical Center, 2500 MetroHealth Drive, Cleveland, OH, 44109, USA. jmangel@metrohealth.org.

International Urogynecology Journal
|June 22, 2026
PubMed
Summary
This summary is machine-generated.

The Intibia System implantable tibial nerve stimulation (ITNS) significantly improved quality of life for urgency urinary incontinence (UUI) patients compared to sham controls. Patients reported meaningful improvements in symptoms and well-being after 3 and 12 months of treatment.

Keywords:
RandomizedImplantable tibial nerve stimulationIntibiaQuality of lifeSham

Related Experiment Videos

Area of Science:

  • Urology
  • Neurology
  • Medical Devices

Background:

  • Urgency urinary incontinence (UUI) severely impacts patients' quality of life (QoL) and social well-being.
  • Effective treatment options for UUI are crucial for improving patient outcomes.

Purpose of the Study:

  • To evaluate the impact of the Intibia System implantable tibial nerve stimulation (ITNS) on QoL in UUI patients.
  • To compare the efficacy of ITNS against a sham control in improving patient-reported outcomes.

Main Methods:

  • A prospective, randomized, double-blind, sham-controlled trial (Intibia Pivotal Study) involving 208 subjects.
  • Subjects received either ITNS treatment (ITNS-ON) or a sham procedure (ITNS-SHAM), with crossover for the sham group after 3 months.
  • Quality of life and patient-reported outcomes were assessed using validated questionnaires at 3, 6, and 12 months post-implant.

Main Results:

  • Significantly more ITNS-ON subjects reported substantial improvement at 3 months compared to ITNS-SHAM (29.2% vs 13.4%, p=0.0133).
  • ITNS-ON patients achieved higher rates of minimally clinically important difference (MCID) in symptom bother and QoL compared to ITNS-SHAM at 3 months.
  • At 12 months, 83% of ITNS-ON subjects reported improvement from baseline, with 71.5% exceeding MCID in key incontinence measures.

Conclusions:

  • The Intibia System ITNS provides statistically and clinically significant improvements in disease-specific QoL for UUI patients.
  • The device demonstrated meaningful benefits compared to sham at 3 months and compared to baseline at 12 months.