business buildings

Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence

Viveve Medical, Inc. , a medical technology company focused on women’s health and the treatment of female stress urinary incontinence (SUI), today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023.  The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment group versus the sham control group. Read more.

Source: Accesswire, January 17, 2023

clinical medical

Cellf BIO Begins Phase 1 Clinical Trial of BioSphincter™ Implant for Fecal Incontinence

Cellf BIO, a biotechnology company that manufactures bioengineered sphincters using autologous progenitor cells, announced today that it has begun its Phase 1 clinical trial for its BioSphincter™ Implant for the treatment of severe passive fecal incontinence (FI). The FDA cleared the company’s Investigational New Drug (IND) application, and the Institutional Review Board (IRB) approved the trial to begin enrolling participants. Read more.

Source: Globe Newswire, January 5, 2023

Myrbetriq Plus Pelvic Floor Exercises Fail to Ease Overactive Bladder

Combining Myrbetriq (mirabegron) with modifications like pelvic floor exercises failed to ease overactive bladder symptoms in people with Parkinson’s disease in a pilot clinical trial, the study’s main goal.  But the treatment, approved for overactive bladder, when used with such behavioral modifications did increase the amount of urine patients were able to expel with each urination, relative to patients using only pelvic floor exercise. But this benefit was temporary. Read more.

Source: Parkinson’s News Today, December 7, 2022

bacteria biofilm indwelling catheter

Urinary Tract Infections: A New Antibiotic May Be on the Way to Treat UTIs

A new type of antibiotic for treating urinary tract infections (UTIs) may be available sooner than expected. Gepotidacin, manufactured by the pharmaceutical company GSK, is being described as “novel” or “first-in-class” because of how it works to prevent or slow bacterial DNA replication. If approved, gepotidacin would be the first new antibiotic developed for treating UTIs in more than 20 years. It would also be available at least a year ahead of the estimated study completion date. Read more.

Source: healthline, November 8, 2022

clinical medical

Neuspera Medical® Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its SANS-UUI IDE Clinical Trial

Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced the first patient successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). The procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN. The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms. Read more.

Source: PRNewsire, October 10, 2022

senior care home

NorthShore Care Supply Begins Clinical Trial to Re-Evaluate Protocols with Senior Care Facilities & Residents Managing Heavy Incontinence

NorthShore Care Supply’s first clinical trial begins in senior care facilities. The trial will test a new approach to incontinence care for residents.  Since 2002, NorthShore has served over 2.5 million families in the United States. Several thousand 5-star customer reviews state that NorthShore products give adults more confidence and better sleep. Family caregivers also notice more sleep and fewer nighttime changes. Maintaining healthy skin is a top concern for individuals who wear adult diapers, and NorthShore delivers. Read more.

Source: Globe Newswire, August 6, 2022

operating room surgery

Simpler Surgery May Work As Well As Standard For Women With Incontinence

For women with frequent urine leakage, a newer and simpler “sling” surgery works as well as the standard version, according to a new clinical trial.  The study involved women with stress urinary incontinence, where movement that puts pressure on the abdomen — such as running, lifting, coughing or laughing — causes urine leakage. When the condition is severe, surgery may be recommended.  Read more.

Source: UPI, April 1, 2022

female doctor

Vibegron Update Shared as FDA Weighs Approval in OAB

The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary.  Read more. 

Source: Urology Times, November 20, 2020

clinical medical

Viveve Announces FDA Approval to Conduct PURSUIT Trial for Improvement of Stress Urinary Incontinence

Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.

Source: BioSpace, July 7, 2020

hormones change as women age

Renovia Launches “REDUCE” – a Multi-Center Randomized Controlled Trial to Study Next-Generation leva® Pelvic Digital Therapeutic System for Urinary Incontinence

Renovia Inc. (“Renovia”), a company dedicated to discovering and delivering first-line digital therapeutic and diagnostic devices for women with pelvic floor disorders, today announced it has launched a large, multi-center randomized controlled trial (RCT) to study the efficacy of a first-line non-surgical digital therapeutic for the treatment of stress-dominant urinary incontinence (UI). Pelvic floor muscle exercises (PFME), also known as Kegel exercises, are the widely accepted first-line conservative treatment for pelvic floor disorders including stress, urgency, and mixed UI within the urogynecology, urology and physical therapy communities. However, many women have trouble identifying and contracting the correct muscles when performing these exercises, and remembering to perform the exercises regularly can be challenging. Read more.

Source: Business Wire, November 12, 2018