Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms

NCT04758247 | Completed FDA Device

• 1 other identifier: CRD-10-1330
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries.

  12 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Device: TheraNova Neuromodulation System

Sham

SHAM COMPARATOR

Device: TheraNova Neuromodulation System

Interventions

TheraNova Neuromodulation System DEVICE

The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.

Active; Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men ≥18 years of age
• Individual has a diagnosis of OAB with urge urinary incontinence or mixed incontinence (urge and stress) with urge urinary incontinence being the most bothersome type of urinary incontinence for at least 6 months (self-reported)
• Individual has ≥4 incontinence events with associated moderate or severe urgency (UUI events), with at least one UUI event per day, as recorded in the baseline 3-day voiding diary
• Individual has a mean frequency of urinary voiding events per day ≥10 times in one 24-hour day as recorded in the baseline 3-day voiding diary
• Individual is ambulatory and able to use the toilet independently
• Individual has not taken antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment
• Individual is able to provide informed consent
• Individual is capable and willing to follow all study-related procedures

You may not qualify if:

• Individual has stress urinary incontinence as the most bothersome type of urinary incontinence (self-report)
• Individual has an abnormal post-void residual urine volume (\>150 cc at baseline)
• Male who has a clinically significant bladder outlet obstruction (assessed by uroflow, maximum flow rate \<15 mL/s for a voided volume of at least 150 cc)
• Male who has been previously diagnosed with Benign Prostate Hyperplasia
• Male who has abnormal serum PSA (\>2.5 ng/mL)
• Individual has abnormal serum creatinine levels (\>1.2 mg/dL for women and \>1.4 mg/dL for men)
• Individual has history of chronic kidney disease
• Female of childbearing age (≤50 years old) who is pregnant as confirmed by urine pregnancy test, or who plans to become pregnant during the study period
• Female who is less than one-year post-partum and/or is breast-feeding
• Female with a clinically significant pelvic organ prolapse (≥ stage III on POP-Q evaluation)
• Individual has diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C ≥ 8.5)
• Individual has known polyuria
• Individual has an active urinary tract infection (UTI) at the time of enrollment
• Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
• Individual has peripheral arterial disease

Sponsors & Collaborators

• Theranova, L.L.C.: lead

Study Sites (2)

UC Davis Health

Sacramento, California, 95817, United States

Location

Stanford Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 17, 2021
• Study Start: October 28, 2021
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (2)