CompletedNot Applicable

Effectiveness and Safety of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation

Netherlands23 participantsStarted 2018-02-02

Plain-language summary

Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit) constipation is of suboptimal quality. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group. Study design: A prospective cohort study with one group. This study is conducted next to a randomized controlled clinical trial (RCT) on 'the effectiveness and cost-effectiveness of sacral neuromodulation in patients with idiopathic slow-transit constipation refractory to conservative treatments' (for more information ClinicalTrial.gov ID: NCT02961582). This RCT is part of a temporary reimbursement arrangement, called conditional reimbursement of health care (in Dutch: Voorwaardelijke Toelating) of the National Health Care Institute (Zorginstituut Nederland). As part of this arrangement, the Ministry of Health, Welfare and Sports requires that SNM remains available for eligible patients during the conditional reimbursement period, also when inclusion of the RCT has ended. Furthermore, the Ministry requires that patients who received personalized conservative treatment in the RCT (control group), are offered SNM after completion of their follow-up of 6 months. As a result, the National Health Care Institute requires that the patients who receive SNM outside the RCT are included in a prospective cohort study to be able to collect data on them. Aim: The aim of this prospective cohort study is to collect more (but uncontrolled) information regarding the safety and effectiveness of SNM. Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic slow-transit constipation refractory to conservative treatment. Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of two phases. In the screening phase an electrode is inserted near the third sacral nerve and connected to an external stimulator. If the screening phase is successful (average defecation frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the buttocks of the patient. If not successful, the pacemaker will be removed and patients receive conservative treatment. Main study parameters/endpoints: The primary outcome is treatment success at 6 months, defined as an average DF of ≥3 a week according to a 3-week defecation diary and safety. Secondary outcomes are straining, sense of incomplete evacuation, constipation severity and generic (health-related) quality of life ((HR)QOL).

Who can participate

Age range

14 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * An average defecation frequency (DF) of \<3 per week based on a 3-week defecation diary (patient-reported) * Meet at least one other criterion of the Rome-IV criteria for idiopathic constipation based on the 3-week defecation diary (1) * Refractory to conservative treatment * Age: 14-80 years * Slow-transit constipation (1) Rome-IV criteria for idiopathic constipation: * Straining during ≥25% of defecations * Lumpy or hard stools in ≥25% of defecations * Sensation of incomplete evacuation for ≥25% of defecations * Sensation of anorectal obstruction/blockage for ≥25% of defecations * Manual manoeuvres to facilitate ≥25% of defecations Exclusion Criteria: * Obstructed outlet syndrome (objectified by defeacography) * Irritable bowel syndrome (Rome-IV criteria for irritable bowel syndrome) * Congenital or organic bowel pathology * Rectal prolapse * Anatomical limitations preventing placement of an electrode * Skin and perineal disease with risk of infection * Previous large bowel/rectal surgery * Stoma * Coexisting neurological disease * Significant psychological co-morbidity as assessed subjectively by the investigator * Being or attempting to become pregnant during study follow-up

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment success at 6 months

Timeframe: 6 months

Complications/adverse events

Timeframe: 6 months

Trial details

NCT IDNCT02961465

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-31

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