NCT02961582

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

Completed NA Last updated 13 June 2022

What this trial tests

NA trial testing Sacral Neuromodulation in Constipation in 67 participants. Completed in 31 December 2021.

Timeline

21 February 2017

Primary endpoint
31 July 2021

31 December 2021

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	21 February 2017
Primary completion	31 July 2021
Estimated completion	31 December 2021
Sites	2 locations across Netherlands

Drugs / interventions tested

• Sacral Neuromodulation
• Personalized Conservative Treatment

Conditions studied

• Constipation — all drugs for Constipation →
• Surgery — all drugs for Surgery →

Sponsor

Maastricht University Medical Center

Who can join

Adults 14 to 80, any sex, with Constipation or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Objective: The main objective of this study is to assess the effectiveness of SNM compared to personalized conservative treatment (PCT), in patients with idiopathic slow-transit constipation who are refractory to conservative treatment. The secondary objectives are assessing the 1) costs, 2) cost-effectiveness and 3) budget-impact of SNM compared to PCT.

Hypothesis: Based on previous research we hypothesize that SNM will be more effective than PCT in terms of a significantly higher proportion of patients having treatment success at 6 months.

Study design: An open-label pragmatic randomized controlled trial (RCT) combined with a prospective cohort study.

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, patients receive conservative treatment. The control intervention is PCT. This is the best and least invasive alternative to SNM. PCT consists of medication and/or retrograde colonic irrigation.

Main study parameters/endpoints: The primary outcome is success at 6 months, defined as an average DF of ≥3 a week according to a 3-week defecation diary. Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic (health-related) quality of life ((HR)QOL), and costs at 6 months. Furthermore, cost-effectiveness and budget-impact will be estimated.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sacral neuromodulation versus personalized conservative treatment in patients with idiopathic slow-transit constipation: study protocol of the No.2-trial, a multicenter open-label randomized controlled trial and cost-effectiveness analysis.
   Heemskerk SCM, Rotteveel AH, Benninga MA, Baeten CIM, et al · · 2018 · cited 7× · PMID 29470731 · DOI 10.1007/s00384-018-2978-x
2. Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial.
   Heemskerk SCM, Dirksen CD, van Kuijk SMJ, Benninga MA, et al · · 2024 · cited 6× · PMID 37991178 · DOI 10.1097/sla.0000000000006158