Skip to content
DraconiticResearch
Search Sources API
203,203 studies31 sourcesUpdated 45 min ago
Peer-reviewedCC BY 4.0International Urogynecology Journal

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

  • Jeffrey Mangel1
  • Kevin Miller2
  • Ty Erickson3
  • Alexis Dieter4
  • Jan-Paul Roovers5
  • Catherine A. Matthews6
6 affiliations
  1. 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
  2. 2School of Medicine-Wichita Department of Obstetrics & Gynecology, University of Kansas, Wichita, KS USA
  3. 3Division of Urogynecology, Kirk Kevorkian School of Medicine, Las Vegas, NV USA
  4. 4Urogynecology & Reconstructive Pelvic Surgery, MedStar Washington Hospital Center, Departments of OBGYN and Urology, Georgetown University School of Medicine, Washington, DC USA
  5. 5Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
  6. 6Division Head and Fellowship Director, Female Pelvic Health; Department of Urology, Wake Forest University School of Medicine, Winston-Salem, NC USA
Read full textPDFDOICite

Abstract

Introduction and Hypothesis: Urgency urinary incontinence (UUI) is associated with significant impairments to quality of life (QoL) and overall social well-being. The aim of this analysis was to assess the impact of the Intibia System implantable tibial nerve stimulation (ITNS) device on QoL in patients with UUI and compare with a sham control.

Methods: The Intibia Pivotal Study was a prospective, randomized, sham-controlled, double-blind trial across the USA and the Netherlands. A total of 208 subjects were randomized to either an ITNS treatment group (ITNS-ON, n = 139) or a sham control group (ITNS-SHAM, n = 69). ITNS-SHAM subjects crossed over after 3 months. Disease-specific questionnaires regarding QoL and patient-reported outcomes were used to assess the impact of the Intibia System at 3, 6, and 12 months post-implant.

Results: At 3 months, significantly more ITNS-ON subjects reported feeling “much better” or “very much better” than ITNS-SHAM subjects (29.2% vs 13.4%, p = 0.0133); ITNS-ON subjects also exceeded the minimally clinically important difference (MCID) at a higher rate than the ITNS-SHAM group for the Overactive Bladder Questionnaire Short Form Symptom Bother (62.8% vs 41.8%; p = 0.0046) and Health-Related Quality of Life sub-scales (57.4% vs 42.4%; p = 0.0463). At 12 months, 83% of ITNS-ON subjects reported any level of improvement compared with baseline. Significant improvements within the ITNS-ON group were observed in the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form over 12 months, with 71.5% of subjects exceeding the MCID.

Conclusions: The Intibia System demonstrated statistically and clinically meaningful improvements in self-reported, disease-specific QoL measures in patients with UUI compared with sham at 3 months and compared with baseline at 12 months.

Related

  1. Adjunctive Immersive Virtual Reality for Urinary Incontinence-Related Quality of Life in Postmenopausal Women with Urinary Incontinence: A Non-Randomized Controlled Pilot Trial
    Gabriela Kołodyńska, Błażej Cieślik, Aleksandra Piątek +3
    Journal of clinical medicinePeer-reviewedCC BYFull textGeneral medicineEurope PMCCrossref
  2. The effect of pelvic floor muscle exercise, progressive muscle relaxation exercise, and their combined application on comfort in women with stress urinary incontinence: a four-arm randomized controlled trial
    Ahmet Şanlı, Gamze Göke Arslan, Demet Çelik +1
    Frontiers in medicinePeer-reviewedCC BYFull textGeneral medicineEurope PMCPMC
  3. ‘Efficacy and safety outcomes after slings or artificial urinary sphincter implantation for non-neurogenic male stress urinary incontinence: a systematic review’ for more clarity
    Cyrille Guillot-Tantay, Sabrina de Cillis, Paolo Geretto +6
    Frontiers in urologyPeer-reviewedCC BYFull textGeneral medicineEurope PMC
  4. Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial
    Lisa Frey, Axel Haferkamp, Walter Lehmacher +9
    eClinicalMedicinePeer-reviewedCC BY 4.0Full textGeneral medicineCrossrefPMC
  5. The impact of clinically and urodynamically classified urinary incontinence subtypes on female sexual function
    Fehmi Ünal, Ayça Kubat Küçükyurt, Selma Atiye Kolcu +1
    Scientific ReportsPeer-reviewedCC BY-NC-ND 4.0Full textGeneral medicineCrossref

Cite

BibTeXRIS
BibTeX
@article{mangel2026randomized,
  title = {{Randomized, Sham-Controlled, Double-Blind Trial of the Intibia System in Urge Urinary Incontinence: Quality-of-Life Outcomes}},
  author = {Jeffrey Mangel and Kevin Miller and Ty Erickson and Alexis Dieter and Jan-Paul Roovers and Catherine A. Matthews},
  journal = {International Urogynecology Journal},
  year = {2026},
  month = jun,
  doi = {10.1007/s00192-026-06636-1},
  url = {https://doi.org/10.1007/s00192-026-06636-1},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Randomized, Sham-Controlled, Double-Blind Trial of the Intibia System in Urge Urinary Incontinence: Quality-of-Life Outcomes
AU  - Jeffrey Mangel
AU  - Kevin Miller
AU  - Ty Erickson
AU  - Alexis Dieter
AU  - Jan-Paul Roovers
AU  - Catherine A. Matthews
PY  - 2026
DA  - 2026/06/22
JO  - International Urogynecology Journal
DO  - 10.1007/s00192-026-06636-1
UR  - https://doi.org/10.1007/s00192-026-06636-1
AB  - Introduction and Hypothesis: Urgency urinary incontinence (UUI) is associated with significant impairments to quality of life (QoL) and overall social well-being. The aim of this analysis was to assess the impact of the Intibia System implantable tibial nerve stimulation (ITNS) device on QoL in patients with UUI and compare with a sham control.  Methods: The Intibia Pivotal Study was a prospective, randomized, sham-controlled, double-blind trial across the USA and the Netherlands. A total of 208 subjects were randomized to either an ITNS treatment group (ITNS-ON, n = 139) or a sham control group (ITNS-SHAM, n = 69). ITNS-SHAM subjects crossed over after 3 months. Disease-specific questionnaires regarding QoL and patient-reported outcomes were used to assess the impact of the Intibia System at 3, 6, and 12 months post-implant.  Results: At 3 months, significantly more ITNS-ON subjects reported feeling “much better” or “very much better” than ITNS-SHAM subjects (29.2% vs 13.4%, p = 0.0133); ITNS-ON subjects also exceeded the minimally clinically important difference (MCID) at a higher rate than the ITNS-SHAM group for the Overactive Bladder Questionnaire Short Form Symptom Bother (62.8% vs 41.8%; p = 0.0046) and Health-Related Quality of Life sub-scales (57.4% vs 42.4%; p = 0.0463). At 12 months, 83% of ITNS-ON subjects reported any level of improvement compared with baseline. Significant improvements within the ITNS-ON group were observed in the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form over 12 months, with 71.5% of subjects exceeding the MCID.  Conclusions: The Intibia System demonstrated statistically and clinically meaningful improvements in self-reported, disease-specific QoL measures in patients with UUI compared with sham at 3 months and compared with baseline at 12 months.
SN  - 0937-3462
SN  - 1433-3023
ER  -