Interferential therapy for chronic constipation in adults: The CON-COUR randomizedcontrolled trial

Area of Science:

• Gastroenterology
• Medical Devices
• Clinical Trials

Background:

• Chronic constipation (CC) affects many adults, with nearly half dissatisfied with current treatments.
• First-line CC treatments include diet, laxatives, and biofeedback, but efficacy is often limited.
• This study investigated transabdominal electrical stimulation via interferential therapy (IFT) for adult CC.

Purpose of the Study:

• To assess the effectiveness of transabdominal interferential therapy (IFT) in treating chronic constipation (CC).
• To evaluate IFT's impact on bowel movement frequency, symptoms, quality of life, and physiological measures in CC patients.

Main Methods:

• A phase 3, randomized, double-blind, sham-controlled, multicenter trial involving 7 French centers.
• Primary endpoint: 8-week efficacy based on complete spontaneous bowel movements (CSBMs).
• Secondary endpoints: Patient Assessment of Constipation Symptoms (PAC-SYM), quality of life, colonic transit time (CTT), manometry, and patient satisfaction.

Main Results:

• The primary endpoint of a significant difference in 8-week responders between IFT and sham groups was not met.
• IFT significantly improved overall PAC-SYM scores and symptom reduction compared to sham.
• No significant differences were found in CTT, anorectal manometry, or patient satisfaction between groups.

Conclusions:

• Transabdominal interferential therapy (IFT) significantly alleviates symptoms and improves quality of life in chronic constipation patients, despite not meeting the primary endpoint for bowel movement frequency.
• The findings suggest that patient-reported outcomes are crucial for evaluating new CC treatments.
• Further research may be needed to refine evaluation methods for novel therapeutic targets in CC.