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

NACompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

February 21, 2017

Primary Completion Date

July 31, 2021

Study Completion Date

December 31, 2021

Conditions
ConstipationSurgery
Interventions
DEVICE

Sacral Neuromodulation

"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."

OTHER

Personalized Conservative Treatment

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.

Trial Locations (2)

6229 HX

Maastricht University Medical Centre, Maastricht

2800 BB

Groene Hart Ziekenhuis, Gouda

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Dutch National Health Care Institute

OTHER

collaborator

Medtronic

INDUSTRY

lead

Maastricht University Medical Center

OTHER

NCT02961582 - Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation | Biotech Hunter | Biotech Hunter