Fecal Incontinence
Conditions
Keywords
fecal incontinence, anal stimulation, pelvic floor training
Brief summary
Fecal incontinence is a disabling condition that can substantially impair quality of life. This study evaluates whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is superior to electrical stimulation alone in patients with fecal incontinence. The study is a prospective, randomized, parallel-group, open-label controlled trial. Participants will be randomized in a 1:1 ratio to either electrical stimulation with synchronized active sphincter contraction or electrical stimulation alone. The primary outcome is the change in Vaizey/St. Mark's Incontinence Score from baseline to week 12. Secondary outcomes include fecal incontinence episodes, quality of life, anorectal manometry parameters, adherence, safety, and sustained response during follow-up.
Detailed description
This prospective randomized controlled trial will compare two home-based rehabilitation approaches for fecal incontinence. Eligible adult patients with urge, passive, or mixed fecal incontinence will be enrolled at study site: University Hospital Martin, Slovakia. Possibility to incorporate another study centre with be allowed. Participants will be randomized in a 1:1 ratio to one of two treatment arms. In the active treatment arm, participants will use anal electrical stimulation combined with active voluntary anal sphincter contraction. Electrical stimulation will be delivered using the commercially available NeuroTrac Continence device with a frequency of 40 Hz, pulse width of 250 µs, 5-second ON and 10-second OFF cycles, 1-second ramp-up, and a session duration of 25 minutes. Stimulation intensity will be adjusted by the patient up to the maximum tolerable level without pain. Participants will be instructed to perform a maximum voluntary anal sphincter contraction for 5 seconds at the start of each stimulation ON cycle and to relax during the rest phase. In the control intervention arm, participants will use identical electrical stimulation parameters but will remain relaxed during stimulation and will not perform active voluntary sphincter contractions. Both groups will receive standardized patient education, including device training and written instructions. The intervention period will last 12 weeks. Study assessments will include the Vaizey/St. Mark's Incontinence Score, Fecal Incontinence Quality of Life scale, 14-day bowel diary, adherence assessment, adverse event monitoring, and high-resolution anorectal manometry. Optionally patients will be also assessed by endoanal ultrasound to detect possible structural abnormalities where clinical suspicion of these will be present. Assessments will be performed at baseline, week 12, and week 36 (as a post treatment follow up), with interim phone or secure online follow-up for adherence and safety. The primary endpoint is the mean change in Vaizey/St. Mark's Incontinence Score from baseline to week 12. Secondary endpoints include changes in weekly fecal incontinence episodes, FIQL subscales, anorectal manometry parameters, treatment adherence, adverse events, and sustained clinical improvement during follow-up.
Interventions
DEVICEHome-based anal electrical stimulator
Home-based anal electrical stimulation delivered using the NeuroTrac Continence device. Stimulation parameters include frequency 40 Hz, pulse width 250 µs, 5 seconds ON and 10 seconds OFF cycles, 1-second ramp-up, session duration 25 minutes, and patient-adjusted intensity up to the maximum tolerable level without pain.
Sponsors
University Hospital, Martin
Comenius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention, neither participants nor investigators can be blinded. Participants are aware whether they perform active voluntary sphincter contractions during stimulation, and investigators are involved in patient training and outcome assessments.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either home-based anal electrical stimulation combined with active voluntary anal sphincter contraction or electrical stimulation alone. Both interventions will be performed for 12 weeks using identical stimulation parameters.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Age ≥18 years * Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months * Vaizey (St. Mark's) Incontinence Score ≥8 * Ability to understand study procedures and comply with the 12-week home intervention * Willingness to attend all study visits and assessments * Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment
Exclusion criteria
* Complete spinal cord injury above the conus medullaris * Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission * Rectal prolapse requiring surgical intervention * Severe symptomatic hemorrhoids interfering with anorectal assessments or device use * Active anal fissure or perianal fistula * Active colorectal cancer or history of colorectal cancer within 5 years * Colorectal surgery within the previous 6 months * Pregnancy or planned pregnancy during study participation * Implanted cardiac pacemaker or defibrillator * Other implanted electrical devices contraindicating electrical stimulation * Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization * Cognitive impairment preventing understanding of study procedures or informed consent * Uncontrolled severe diarrhea (\>5 liquid stools/day) * Anal stenosis preventing probe insertion * Severe anal sphincter defect (\>120° on ultrasound) requiring surgical repair * Isolated severe rectal sensory dysfunction without significant sphincter dysfunction * Previous pelvic radiotherapy * Concurrent participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12 | Baseline to Week 12 | Mean change in Vaizey (St. Mark's) Incontinence Score between baseline and week 12. The Vaizey score ranges from 0 to 24, with higher scores indicating more severe fecal incontinence symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12 | Baseline to Week 12 | Mean change in the number of weekly fecal incontinence episodes recorded in a 14-day bowel diary. |
| Proportion of Participants Achieving ≥30% Reduction in Vaizey Score at Week 12 | Week 12 | Percentage of participants achieving at least a 30% reduction in Vaizey (St. Mark's) Incontinence Score compared with baseline. |
| Sustained Improvement in Vaizey Score at Week 36 | Baseline to Week 36 | Mean change in Vaizey (St. Mark's) Incontinence Score at long-term follow-up compared with baseline. |
| Change in Maximum Squeeze Pressure on High-Resolution Anorectal Manometry | Baseline to Week 12 | Mean change in maximum squeeze pressure measured by high-resolution anorectal manometry (HRAM). |
| Change in Resting Anal Pressure on High-Resolution Anorectal Manometry | Baseline to Week 12 | Mean change in resting anal pressure measured by high-resolution anorectal manometry (HRAM). |
| Change in Squeeze Endurance on High-Resolution Anorectal Manometry | Baseline to Week 12 | Mean change in squeeze endurance measured during HRAM assessment. |
| Change in Fecal Incontinence Quality of Life (FIQL) Scores | Baseline to Week 12 | Mean change in FIQL subscale scores (Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment) from baseline. FIQL subscale scores range from 1 to 4, with higher scores indicating better quality of life. |
| Treatment Adherence Rate | During the 12-week intervention period | Percentage of prescribed home stimulation sessions completed during the 12-week intervention period |
| Incidence of Adverse Events and Device-Related Complications | Baseline to Week 36 | Number and type of adverse events and device-related complications reported during the study period. |
Countries
Slovakia
Contacts
CONTACTPeter Liptak, MD, PHD
CONTACTAdam Lukac, MD
STUDY_DIRECTORPeter Liptak, MD, PhD
Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia
Outcome results
None listed