Constipation is one of the most common and disabling non-motor symptoms of Parkinson's disease (PD), often resulting in reduced quality of life and increased healthcare burden. Standard bowel care (SBC), including dietary modifications, fluid intake, physical activity, and laxative therapy, may not provide adequate symptom control in patients with severe constipation.
The purpose of this study is to evaluate whether transanal irrigation (TAI) using the Qufora Flow device is more effective than SBC in improving bowel function in patients with PD and severe constipation. In addition to bowel symptom improvement, the study will investigate the potential effects of TAI on gut microbiota composition, motor and non-motor symptoms of PD, treatment adherence, and safety.
Participants will be randomly assigned to receive either TAI or SBC and will be followed for 24 months. Clinical assessments, patient-reported outcome measures, and stool samples will be collected throughout the study to evaluate treatment effectiveness and to explore the relationship between bowel management, gut microbiota, and Parkinson's disease progression.
Provision of informed consent.
Female or male aged 18 years or above.
Established diagnosis of PD according to MDS criteria
Patients with bowel symptoms post-dating and related to a diagnosis of PD.
Any confirmed or suspected diagnosis of anal or colorectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.
Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-PD related neuro complications).
Opioid consumption ≤24 hours prior enrolment.
Taking probiotics in the past 30 days.
Parallel
Transanal Irrigation System
DeviceTransanal irrigation performed using a CE-marked transanal irrigation system (Irrisedo Flow, Qufora, Allerød, Denmark) for the management of neurogenic bowel dysfunction in patients with Parkinson's disease. Participants randomized to this arm will receive training on device use and will perform irrigation according to clinical practice and individual needs throughout the study period.
Standard Bowel Care
Other interventionStandard bowel care including lifestyle advice (dietary and behavioral recommendations) and the use of laxative agents as clinically indicated. Participants will receive the same frequency of clinical follow-up as the experimental arm.
Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)
Constipation severity will be assessed using the Cleveland Clinic Constipation Score (Wexner Constipation Score). The score ranges from 0 to 30, where higher scores indicate more severe constipation. The outcome measure will be the change from baseline in total score at each assessment.
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score
Quality of life related to constipation will be assessed using the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The total score ranges from 0 to 4, with higher scores indicating poorer constipation-related quality of life. The outcome measure will be the change from baseline in total score.
Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score
Bowel dysfunction severity will be assessed using the Neurogenic Bowel Dysfunction (NBD) Score. The score ranges from 0 to 47, with higher scores indicating more severe bowel dysfunction. The outcome measure will be the change from baseline in total score.
Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score)
Fecal incontinence severity will be assessed using the Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score). The score ranges from 0 to 20, with higher scores indicating more severe fecal incontinence. The outcome measure will be the change from baseline in total score.
Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS)
Patient satisfaction with bowel management and study treatment will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where higher scores indicate greater satisfaction. The outcome measure will be the change from baseline.
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University Hospital of Ferrara
Lead sponsor
Azienda Policlinico Umberto I
Collaborator
Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine
Collaborator
ISS Istituto per la Sicurezza Sociale, San Marino
Collaborator
Hospital of Prato
Collaborator
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