Recruiting

Digital Conversational Agent

Sponsor:

Renalis

Code:

NCT04853849

Conditions

Overactive Bladder

Urge Incontinence

Pelvic Floor Disorders

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.

Conditions

Overactive Bladder

Urge Incontinence

Pelvic Floor Disorders

Study ID

NCT04853849

Start date

Aug 26, 2021

Status verified date

Nov, 2021

Completion date

Apr 30, 2024

Anticipated

Primary completion date

Apr 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Symptoms of overactive bladder with urgency urinary incontinence, with or without nocturia/nocturnal enuresis
  • Symptoms of mixed urinary incontinence if urgency incontinence is the predominant complaint
  • Post-void residual <100ml
  • English speaking
  • Access to a smartphone
  • Normal urinalysis without evidence of UTI, gross or microscopic hematuria
  • Greater than 6 months since receiving intradetrusor injection of botulinum toxin
  • Not currently undergoing sacral neuromodulation therapy
  • Not currently receiving pharmacotherapy for overactive bladder

Exclusion Criteria:

  • Less than 40 years of age
  • Mixed incontinence with predominant stress urinary incontinence symptoms
  • Diagnosis of chronic pelvic pain
  • symptomatic pelvic organ prolapse
  • symptoms of dysuria
  • Diagnosis of interstitial cystitis/painful bladder syndrome
  • Reported >2 UTI in 6 months or >3 in 12 months
  • Do not have access to a smartphone
  • Non-English speaking
  • Diagnosis of neurogenic bladder
  • Gross or microscopic hematuria
  • Has diagnosis of dementia, cognitive impairment or other neurologic condition which impairs decision making
  • Current Pharmacotherapy or neuromodulation therapy
  • Less than 6 months since intradetrusor botulinum toxin injection
  • Has decreased mobility or ambulation
  • Has post-void residual >100 mL
  • Has BMI > 40 kg/m\^2
  • Inability to voluntarily contract the pelvic floor muscles (a 0/5 in strength).
  • Has >4/10 pain with palpation of levator ani, coccygeus, pyriformis, obturator internus or perineal body

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change of overactive bladder quality of life measure [ Time Frame: Baseline, 4 weeks, and 8 weeks ]

Central Contacts and Locations

Central contacts

Yufan Chen, MD

510-364-2122brandon@renalis.health

Missy Lavender

Missy@renalis.health

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

More Information

Sponsor

Renalis

Last update posted

Dec 10, 2021

Last verified

Nov, 2021

Keywords

  • Digital therapeutic
  • Overactive bladder
  • Urge incontinence
  • Pelvic floor disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Renalis on 2021-12-10.