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ConstipationNCT02961465

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

An observational study of Constipation and Surgery, run by Maastricht University Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Type of treatment
Medical device
How many people
23 participants
Where
2 sitesNetherlands
Study dates
2 Feb 2018to 31 Dec 2021
Phase
Observational
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

Study population: The study population consists of adolescents (14-17 years) and adults (18-80 years) with idiopathic slow-transit constipation refractory to conservative treatment. As data regarding this population is limited it is virtually impossible to provide precise numbers of this patient population. However, some numbers are known: * Average prevalences of idiopathic constipation of 16% and 19.2% are reported in Europe * Of all patients treated for constipation, 5.6% is treated at the hospital * It is estimated that 1% of the constipation patients who are treated with conservative treatment in hospitals, are unresponsive and are eligible for sacral neuromodulation * Over the last 6 years, annually, on average, 25 patients were treated with SNM at the Maastricht UMC+ and the Groene Hart Ziekenhuis Gouda

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, 6229HX

Other trials in Netherlands

About this study

Official title: Effectiveness and Safety 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.

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.

Read more

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).

Being tested
Sacral Neuromodulation
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 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.

Study groups in NCT02961465
Study groupRoleWhat they receive
Sacral Neuromodulation (SNM)Not described
Receives: Device: Sacral Neuromodulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Complications/adverse events

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

    Measured: 6 months

Secondary outcomes (4)

  1. 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. 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.

    Measured: Baseline, 1, 3 and 6 months, (12 months)

  2. 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. 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.

    Measured: Baseline, 1, 3 and 6 months, (12 months)

  3. Constipation severity

    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.

    Measured: Baseline, 1, 3 and 6 months, (12 months)

  4. Generic (HR)QOL

    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.

    Measured: Baseline, 1, 3 and 6 months, (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2016 (estimated)
  2. Study start2 Feb 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02961465
Sponsor's protocol ID
METC161044
Status last verified
Feb 2022
First submitted
8 Nov 2016
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
Yes
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 21382575

  • Suares 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 21606976

  • van 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 22469794

Questions about this trial

What is this clinical trial studying?

An observational study of 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 4 Feb 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). The study lists 2 primary outcomes in all. 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 NCT02961465, which also lists 3 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 4 Feb 2022.

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