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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT02961465
• Date of registration: 08/11/2016
• Prospective Registration: Yes
• Primary sponsor: Maastricht University Medical Center
• Public title: Effectiveness and Safety of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation
• Scientific title: Effectiveness and Safety of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments
• Date of first enrolment: February 2, 2018
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02961465
• Study type: Observational

Countries of recruitment

Netherlands

Contacts

• Name: Carmen D Dirksen, Prof. dr.
• Affiliation: Maastricht University Medical Centre

• Name: Stéphanie O Breukink, Dr.
• Affiliation: Maastricht University Medical Centre

Key inclusion & exclusion criteria

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



Age minimum: 14 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Surgery

Constipation

Intervention(s)

Device: Sacral Neuromodulation

Primary Outcome(s)

Complications/adverse events [Time Frame: 6 months]

Treatment success at 6 months [Time Frame: 6 months]

Secondary Outcome(s)

Proportion of patients with a 50% reduction in the proportion of defecations with straining [Time Frame: Baseline, 1, 3 and 6 months, (12 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, (12 months)]

Constipation severity [Time Frame: Baseline, 1, 3 and 6 months, (12 months)]

Generic (HR)QOL [Time Frame: Baseline, 1, 3 and 6 months, (12 months)]

Secondary ID(s)

METC161044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic

Dutch National Health Care Institute