FDA approvals

FDA approves Eclipse System for fecal incontinence in women

The FDA approved marketing of the Eclipse System, a nonsurgical vaginal bowel-control system for the treatment of fecal incontinence in women, according to an agency press release.

“Current treatment options for fecal incontinence include drugs, dietary changes, exercise and surgery,” William Maisel, MD, MPH, deputy director of science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the release. “The Eclipse System provides an additional treatment option for women who suffer from this condition.”

William Maisel

According to the release, the Eclipse System (Pelvalon) includes a balloon that is placed in the vagina and inflated to exert pressure through the vaginal wall onto the rectal area, which reduces the number of fecal incontinence episodes. It is intended to treat women aged 18 to 75 years who have at least four fecal incontinence episodes in 2 weeks. Initial fitting and inflation is performed by a clinician after which patients can inflate and deflate the device as needed at home, the release said.

The approval follows positive clinical trial data reported from the LIFE study, which demonstrated that women achieved significant improvement in fecal incontinence by objective and subjective measures.

“The Eclipse insert provides an effective low-risk treatment modality that can be used on its own or combined with other strategies to help control this devastating condition in many women,” study investigator Holly E. Richter, PhD, MD, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama, told Healio Gastroenterology.

LIFE Study

Aiming to determine the safety and efficacy of this device in women with fecal incontinence, Richter and colleagues performed a prospective, open-label trial from August 2012 to April 2014, which involved 110 women from six centers who had a history of fecal incontinence for at least 6 months and at least four fecal incontinence episodes in 2 weeks. Symptoms were measured by questionnaire and treatment diary. The intention-to-treat analysis included the 55.5% of patients who were successfully fit with the device (mean age, 60.8 ± 9.4 years), and the per-protocol analysis included patients who completed at least 7 days in the treatment diary. All patients were assessed for reduction of incontinence episodes at 1 month and invited into an extended-wear period of an additional 2 months.

Holly E. Richter

“The LIFE study results indicate that Eclipse will offer an important new therapeutic option for women with accidental bowel leakage,” Richter said in a press release. “This approach to therapy typically provides immediate effectiveness and allows the patient to be a proactive partner with the provider in the management of a condition that often keeps them being active in family and societal events.”

Treatment was successful in 78.7% (95% CI, 66-88) of the intention-to-treat population and in 85.7% (95% CI, 74-94) of the per-protocol population after 1 month, and 69.6% (95% CI, 56.7-80.6) of the per-protocol population had at least 75% reduction in incontinence episodes, whereas 41.1% (95% CI, 28-55) had complete continence. Regarding bowel control, 57.1% of patients reported it was “very much better” and 28.6% reported it was “much better.” Of the 44 patients who completed the additional 2-month extended wear period, 86.4% (95% CI, 73-95) had treatment success. There were no serious adverse events, and the most common device-related adverse event was pelvic cramping or discomfort (22.7%), mostly occurring during fitting (64%).

A second longer-term outcome study (the LIBERATE study) will soon be underway, Richter said. – by Adam Leitenberger

Disclosure: Richter and other researchers report they have been consultants for Pelvalon. Richter also reports relationships with Kimberly Clark and UpToDate.

The FDA approved marketing of the Eclipse System, a nonsurgical vaginal bowel-control system for the treatment of fecal incontinence in women, according to an agency press release.

“Current treatment options for fecal incontinence include drugs, dietary changes, exercise and surgery,” William Maisel, MD, MPH, deputy director of science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the release. “The Eclipse System provides an additional treatment option for women who suffer from this condition.”

William Maisel

According to the release, the Eclipse System (Pelvalon) includes a balloon that is placed in the vagina and inflated to exert pressure through the vaginal wall onto the rectal area, which reduces the number of fecal incontinence episodes. It is intended to treat women aged 18 to 75 years who have at least four fecal incontinence episodes in 2 weeks. Initial fitting and inflation is performed by a clinician after which patients can inflate and deflate the device as needed at home, the release said.

The approval follows positive clinical trial data reported from the LIFE study, which demonstrated that women achieved significant improvement in fecal incontinence by objective and subjective measures.

“The Eclipse insert provides an effective low-risk treatment modality that can be used on its own or combined with other strategies to help control this devastating condition in many women,” study investigator Holly E. Richter, PhD, MD, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama, told Healio Gastroenterology.

LIFE Study

Aiming to determine the safety and efficacy of this device in women with fecal incontinence, Richter and colleagues performed a prospective, open-label trial from August 2012 to April 2014, which involved 110 women from six centers who had a history of fecal incontinence for at least 6 months and at least four fecal incontinence episodes in 2 weeks. Symptoms were measured by questionnaire and treatment diary. The intention-to-treat analysis included the 55.5% of patients who were successfully fit with the device (mean age, 60.8 ± 9.4 years), and the per-protocol analysis included patients who completed at least 7 days in the treatment diary. All patients were assessed for reduction of incontinence episodes at 1 month and invited into an extended-wear period of an additional 2 months.

Holly E. Richter

“The LIFE study results indicate that Eclipse will offer an important new therapeutic option for women with accidental bowel leakage,” Richter said in a press release. “This approach to therapy typically provides immediate effectiveness and allows the patient to be a proactive partner with the provider in the management of a condition that often keeps them being active in family and societal events.”

Treatment was successful in 78.7% (95% CI, 66-88) of the intention-to-treat population and in 85.7% (95% CI, 74-94) of the per-protocol population after 1 month, and 69.6% (95% CI, 56.7-80.6) of the per-protocol population had at least 75% reduction in incontinence episodes, whereas 41.1% (95% CI, 28-55) had complete continence. Regarding bowel control, 57.1% of patients reported it was “very much better” and 28.6% reported it was “much better.” Of the 44 patients who completed the additional 2-month extended wear period, 86.4% (95% CI, 73-95) had treatment success. There were no serious adverse events, and the most common device-related adverse event was pelvic cramping or discomfort (22.7%), mostly occurring during fitting (64%).

A second longer-term outcome study (the LIBERATE study) will soon be underway, Richter said. – by Adam Leitenberger

Disclosure: Richter and other researchers report they have been consultants for Pelvalon. Richter also reports relationships with Kimberly Clark and UpToDate.