ConstipationNCT02961582
Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation
A study testing Sacral Neuromodulation and Personalized Conservative Treatment in people with Constipation and Surgery, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Constipation, Surgery
- What is being tested?
- Sacral Neuromodulation and Personalized Conservative Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesNetherlands
- Study dates
- 21 Feb 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Rome-IV criteria for idiopathic constipation:
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Groene Hart Ziekenhuis
Gouda, South Holland, 2800 BB
Maastricht University Medical Centre
Maastricht, Limburg, 6229 HX
About this study
Official title: Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments
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.
Read more
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.
- Conditions
- Constipation, Surgery
- Being tested
- Sacral Neuromodulation, Personalized Conservative Treatment
- Keywords
- Sacral neuromodulation, Constipation, Slow-transit constipation, Surgery, Colorectal surgery, Cost-effectiveness, Quality of life
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral NeuromodulationDevice
Also called Medtronic Interstim Therapy System
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 in the intervention group 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.
Personalized Conservative TreatmentOther
Also called Care as usual
The control group will receive the best and least invasive alternative treatment, which is personalized conservative treatment (PCT). PCT includes, a combination of laxative/medication use and/or colonic irrigation, depending on the preferences of the patient. Use of PCT will be documented.
| Study group | Role | What they receive |
|---|---|---|
| Sacral Neuromodulation | Experimental | Not described Receives: Device: Sacral Neuromodulation |
| Personalized Conservative Treatment | Other | Not described Receives: Other: Personalized Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success at 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
Measured: 6 months
Secondary outcomes (11)
Defecation frequency
Defecation frequency based on a patient-reported defecation diary over a period of 3 weeks
Measured: 1 and 3 months
Proportion of patients with a 50% reduction in the proportion of defecations with straining
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.
Measured: Baseline, 1, 3 and 6 months
Proportion of patients with a 50% reduction in the proportion of defecations with a sense of incomplete evacuation
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.
Measured: Baseline, 1, 3 and 6 months
Constipation severity
Displayed with the score from the Wexner constipation score (WCS).
Measured: Baseline, 1, 3 and 6 months
Fatigue
Displayed with the score from the Fatigue Questionnaire (in Dutch 'Verkorte vermoeidheidsvragenlijst' (VVV)) .
Measured: Baseline, 1, 3 and 6 months
Constipation-specific (health-related) quality of life ((HR)QOL)
Displayed with the score from the Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire
Measured: Baseline, 1, 3 and 6 months
Generic (HR)QOL
In adults displayed with the score from the EQ-5D-5L and ICECAP-A In adolescents displayed with the score from the EQ-5D-5L and KIDSCREEN-27
Measured: Baseline, 1, 3 and 6 months
Adverse events/complications
Reported by the clinician in a case report form (CRF)
Measured: Baseline, 1, 3 and 6 months
Resource use/costs
Health care costs, patient and family costs and costs outside the health care sector
Measured: Baseline, 3 and 6 months
Cost-effectiveness
Both from a societal and health care perspective, derived from the EQ-5D-5L scores and cost data obtained in this RCT
Measured: 6 months
Budget-impact
From a societal, health care and health care insurance perspective, derived from the EQ-5D-5L scores and cost data obtained in this RCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start21 Feb 2017
- Primary completion31 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch National Health Care Institute, Medtronic
- Responsible party
- Sponsor
- Investigators
- Stéphanie O Breukink, Dr., Principal investigator, Maastricht University Medical Centre+Carmen D Dirksen, Prof. dr., Principal investigator, Maastricht University Medical Centre+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961582
- Sponsor's protocol ID
- NL57367.068.16
- Status last verified
- Jun 2022
- First submitted
- 12 Oct 2016
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
PubMed 21382575Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.
PubMed 21606976van Wunnik BP, Peeters B, Govaert B, Nieman FH, Benninga MA, Baeten CG. Sacral neuromodulation therapy: a promising treatment for adolescents with refractory functional constipation. Dis Colon Rectum. 2012 Mar;55(3):278-85. doi: 10.1097/DCR.0b013e3182405c61.
PubMed 22469794Heemskerk SCM, Rotteveel AH, Benninga MA, Baeten CIM, Masclee AAM, Melenhorst J, van Kuijk SMJ, Dirksen CD, Breukink SO. 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. Int J Colorectal Dis. 2018 Apr;33(4):493-501. doi: 10.1007/s00384-018-2978-x. Epub 2018 Feb 22.
PubMed 29470731Heemskerk SCM, Dirksen CD, van Kuijk SMJ, Benninga MA, Baeten CIM, Masclee AAM, Melenhorst J, Breukink SO. Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial. Ann Surg. 2024 May 1;279(5):746-754. doi: 10.1097/SLA.0000000000006158. Epub 2023 Nov 23.
PubMed 37991178
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments
- ClinicalTrials.gov ID
- NCT02961582
- Acronym / sponsor ID
- NL57367.068.16
- Conditions
- Constipation, Surgery
- Keywords
- Sacral neuromodulation, Constipation, Slow-transit constipation, Surgery, Colorectal surgery, Cost-effectiveness, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch National Health Care Institute, Medtronic
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral Neuromodulation | Experimental | Device: Sacral Neuromodulation |
| Personalized Conservative Treatment | Other | Other: Personalized Conservative Treatment |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral NeuromodulationAlso: Medtronic Interstim Therapy SystemSNM 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 in the intervention group 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. | Device | Sacral Neuromodulation |
| Personalized Conservative TreatmentAlso: Care as usualThe control group will receive the best and least invasive alternative treatment, which is personalized conservative treatment (PCT). PCT includes, a combination of laxative/medication use and/or colonic irrigation, depending on the preferences of the patient. Use of PCT will be documented. | Other | Personalized Conservative Treatment |
Primary outcome
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
11 secondary outcomes
Defecation frequency
Time frame: 1 and 3 months
Proportion of patients with a 50% reduction in the proportion of defecations with straining
Time frame: Baseline, 1, 3 and 6 months
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
Constipation severity
Time frame: Baseline, 1, 3 and 6 months
Fatigue
Time frame: Baseline, 1, 3 and 6 months
Constipation-specific (health-related) quality of life ((HR)QOL)
Time frame: Baseline, 1, 3 and 6 months
Generic (HR)QOL
Time frame: Baseline, 1, 3 and 6 months
Adverse events/complications
Time frame: Baseline, 1, 3 and 6 months
Resource use/costs
Time frame: Baseline, 3 and 6 months
Cost-effectiveness
Time frame: 6 months
Budget-impact
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 21382575Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
- Background: PubMed 21606976Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.
- Background: PubMed 22469794van Wunnik BP, Peeters B, Govaert B, Nieman FH, Benninga MA, Baeten CG. Sacral neuromodulation therapy: a promising treatment for adolescents with refractory functional constipation. Dis Colon Rectum. 2012 Mar;55(3):278-85. doi: 10.1097/DCR.0b013e3182405c61.
- Background: PubMed 29470731Heemskerk SCM, Rotteveel AH, Benninga MA, Baeten CIM, Masclee AAM, Melenhorst J, van Kuijk SMJ, Dirksen CD, Breukink SO. 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. Int J Colorectal Dis. 2018 Apr;33(4):493-501. doi: 10.1007/s00384-018-2978-x. Epub 2018 Feb 22.
- Derived from this study: PubMed 37991178Heemskerk SCM, Dirksen CD, van Kuijk SMJ, Benninga MA, Baeten CIM, Masclee AAM, Melenhorst J, Breukink SO. Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial. Ann Surg. 2024 May 1;279(5):746-754. doi: 10.1097/SLA.0000000000006158. Epub 2023 Nov 23.
- Individual participant dataSharing planned: No
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie O Breukink, Dr. principal investigator
Maastricht University Medical Centre+
Carmen D Dirksen, Prof. dr. principal investigator
Maastricht University Medical Centre+
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Neuromodulation and Personalized Conservative Treatment in people with Constipation and Surgery, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02961582, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.