VCU Health Leads Clinical Trial For New treatment To Help People With Bowel Control Problems

A research team at VCU Health is leading a clinical trial to assess a novel treatment for fecal incontinence or sudden loss of control over bowel movements. The therapy involves implanting a bioengineered sphincter derived from the patient’s native cells to help them regain control of their bowels.  The implantation surgery for the clinical trial is being led by Jaime Bohl, M.D., an associate professor in the Department of Surgery and chief of the Division of Colon and Rectal Surgery at Virginia Commonwealth University’s School of Medicine. Read more.

Source: VCU Health, February 28, 2024

nurse and patient

Pelvital Announces Landmark Study Demonstrating Efficacy of Flyte® Device in Treating Stress Urinary Incontinence

Pelvital, the women’s health MedTech company on a mission to transform the standard of care for urinary incontinence, announced today the publication of its landmark paper “Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women” in the peer-reviewed journal Therapeutic Advances in Urology. The paper presents evidence of the efficacy of Pelvital’s novel, FDA-cleared device, Flyte, for the treatment of stress urinary incontinence (SUI) and weakened pelvic floor muscles, with results comparable to surgical intervention. Read more.

Source: PRNewsire, February 21, 2024

World’s First Bladder Transplant Will Be Performed By Both Human and Robot Surgeons

A team of urologists at Keck Medicine of the University of South California (USC) is conducting a clinical trial that will soon lead to the first-ever bladder transplant operation in humans. The doctors are currently in the process of selecting participants for their trials.  If successful, such operations would provide relief to millions of people around the globe who live with bladder-related disorders. Inderbir Gill, principal investigator and executive director at Keck Medicine USC Urology, said, “We could be on the verge of a medical advance that has the potential to revolutionize how we treat terminally compromised bladders.” Read more.

Source: Interesting Engineering, May 2, 2023

meeting conference

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session (LBA01-05) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30th. Read more.

Source: PRNewswire, May 1, 2023

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