Skip to main content
OpenTrials
Completed

NCT Number: NCT02961465

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Surgery

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Centre, Maastricht, Limburg, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral Neuromodulation

Device

SNM starts with a screening phase. In this phase a tined lead is inserted into the third sacral foramen and attached to an external stimulator, after which the patient enters a four-week stimulation test period.

If the screening phase is successful (defecation frequency (DF) ≥3 a week), the external stimulator is changed for a pacemaker that is implanted in the buttocks. If the screening phase is unsuccessful (DF <3 a week), the lead is explanted. Patients are asked to limit the use of additional conservative treatments for constipation (such as laxatives and colonic irrigation) to what is necessary to relieve (the most severe) complaints. What is necessary to relieve complaints is determined by the patient.

Other names: Medtronic Interstim Therapy System

Primary outcomes

  1. Treatment success at 6 months

    Time frame: 6 months

    Treatment success is defined as an average defecation frequency of ≥ 3 a week based on a patient-reported defecation diary over a period of 3 weeks

  2. Complications/adverse events

    Time frame: 6 months

    Reported by the clinician in a case report form (CRF)

Secondary outcomes

  1. Proportion of patients with a 50% reduction in the proportion of defecations with straining

    Time frame: Baseline, 1, 3 and 6 months, (12 months)

    The proportion of defecations with straining is derived from the data in the 3 week defecation diary. The reported proportion of defecations with straining is compared with the proportion of defecations with straining at baseline. Patients are divided in two groups: 1) ≥50% reduction in the proportion of defecations with straining and 2) <50% reduction in the proportion of defecations with straining. In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.

  2. Proportion of patients with a 50% reduction in the proportion of defecations with a sense of incomplete evacuation

    Time frame: Baseline, 1, 3 and 6 months, (12 months)

    The proportion of defecations with a sense of incomplete evacuation is derived from the data in the 3 week defecation diary. The reported proportion of defecations with a sense of incomplete evacuation is compared with the proportion of defecations with a sense of incomplete evacuation at baseline. Patients are divided in two groups: 1) ≥50% reduction in the proportion of defecations with a sense of incomplete evacuation and 2) <50% reduction in the proportion of defecations with a sense of incomplete evacuation. In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.

  3. Constipation severity

    Time frame: Baseline, 1, 3 and 6 months, (12 months)

    Displayed with the score from the Wexner constipation score (WCS). In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.

  4. Generic (HR)QOL

    Time frame: Baseline, 1, 3 and 6 months, (12 months)

    Displayed with the score from the EQ-5D-5L. In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch National Health Care Institute
  • Medtronic

Registry information

Official study title

Effectiveness and Safety of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 11, 2016
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.