An interventional study of Transanal Irrigation System and Standard Bowel Care in Parkinson Disease and Constipation, sponsored by University Hospital of Ferrara. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
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.
Constipation affects up to 80% of individuals with Parkinson's disease (PD) and frequently precedes the onset of motor symptoms. It represents one of the most burdensome non-motor manifestations of the disease, significantly impairing quality of life and increasing the need for healthcare interventions. Despite the widespread use of standard bowel care (SBC), many patients continue to experience persistent constipation, highlighting the need for more effective therapeutic strategies.
Transanal irrigation (TAI) is an established bowel management technique that has demonstrated efficacy in patients with neurogenic bowel dysfunction resulting from spinal cord injury, multiple sclerosis, and other neurological disorders. However, evidence regarding its effectiveness in patients with Parkinson's disease remains limited.
This multicenter, randomized controlled trial has been designed to compare the effectiveness of TAI using the Qufora Flow device with SBC in adults with Parkinson's disease and severe constipation. The study will evaluate whether TAI provides superior long-term bowel symptom control while also investigating its impact on patient-reported outcomes, treatment adherence, and safety.
An additional objective of the study is to explore the relationship between bowel management and gut microbiota composition. Increasing evidence suggests that alterations in the gut microbiome may contribute to the pathophysiology and progression of Parkinson's disease through the gut-brain axis. By analyzing longitudinal stool samples, the study aims to determine whether improved bowel management through TAI is associated with changes in gut microbiota and whether these changes correlate with clinical outcomes.
Participants will be followed for 24 months with standardized clinical evaluations and microbiological assessments performed according to the study protocol. The findings are expected to provide new evidence regarding the role of transanal irrigation in the management of constipation associated with Parkinson's disease and to improve understanding of the relationship between bowel function, the gut microbiome, and disease manifestations.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
For inclusion in the study, subjects must fulfil all of the following criteria:
Exclusion Criteria
Any of the following is regarded as a criterion for exclusion from the study:
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive transanal irrigation (TAI) using the Qufora Flow device. Subjects will be trained in proper device use after randomization. Treatment is administered as part of routine management of neurogenic bowel dysfunction in Parkinson's disease. Participants will attend scheduled on-site visits at Baseline, 6 months, and 24 months, and will complete telephone follow-ups at 1 month and 12 months.
Device: Transanal Irrigation System
Participants randomized to this arm will receive standard bowel care (SBC), including lifestyle advice and recommendations for laxative agents as clinically indicated. Subjects will have the same frequency of contact with the investigator or delegate as the experimental arm, including scheduled on-site visits at Baseline, 6 months, and 24 months, and telephone follow-ups at 1 month and 12 months.
Other: Standard Bowel Care
Transanal 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 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.
Time frame: Baseline, 6 months, and 24 months.
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.
Time frame: Baseline, 6 months, and 24 months.
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.
Time frame: Baseline, 6 months, and 24 months.
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.
Time frame: Baseline, 6 months, and 24 months.
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.
Time frame: Baseline, 6 months, and 24 months.
Treatment Adherence
Treatment adherence will be assessed as the number and percentage of participants remaining on the assigned study treatment (TAI or standard bowel care) at each follow-up visit.
Time frame: Baseline, 6 months, and 24 months.
Change From Baseline in Hoehn and Yahr Stage
Disease severity will be assessed using the Hoehn and Yahr staging scale. The scale ranges from Stage 1 to Stage 5, with higher stages indicating more advanced Parkinson's disease. The outcome measure will be the change from baseline in disease stage.
Time frame: Baseline, 6 months, and 24 months.
Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies
Safety will be assessed by recording the number of participants experiencing adverse events (AEs), serious adverse events (SAEs), and device deficiencies during the study period.
Time frame: From randomization until 24 months.
Change in Gut Microbiota Composition
Gut microbiota composition will be assessed from stool samples using microbiological sequencing analysis. Changes in microbial composition and diversity from baseline will be compared between treatment groups.
Time frame: Baseline, 6 months, and 24 months
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Motor and non-motor symptoms will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The total score ranges from 0 to 272, with higher scores indicating greater severity of Parkinson's disease symptoms. The outcome measure will be the change from baseline in the total score.
Time frame: Baseline, 6 months, and 24 months.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Score
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome measure will be the change from baseline in total score.
Time frame: Baseline, 6 months, and 24 months.
Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score
Non-motor symptoms will be assessed using the Non-Motor Symptoms Scale (NMSS). The total score ranges from 0 to 360, with higher scores indicating a greater burden of non-motor symptoms. The outcome measure will be the change from baseline in total score.
Time frame: Baseline, 6 months, and 24 months.
Change From Baseline in SCOPA-AUT Total Score
Autonomic symptoms will be assessed using the Scale for Outcomes in Parkinson's Disease for Autonomic Symptoms (SCOPA-AUT). The total score ranges from 0 to 69, with higher scores indicating more severe autonomic dysfunction. The outcome measure will be the change from baseline in total score.
Time frame: Baseline, 6 months, and 24 months.
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Health-related quality of life will be assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The Summary Index ranges from 0 to 100, with higher scores indicating poorer quality of life. The outcome measure will be the change from baseline in the Summary Index.
Time frame: Baseline, 6 months, and 24 months.
Change From Baseline in Levodopa Equivalent Daily Dose (LEDD)
The Levodopa Equivalent Daily Dose (LEDD), expressed in milligrams per day (mg/day), will be recorded to assess changes in dopaminergic therapy during the study. The outcome measure will be the change from baseline in LEDD.
Time frame: Baseline, 6 months, and 24 months.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 24 months is close to that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital of Ferrara →