Effectiveness and cost-effectiveness of sacral neuromodulation in patients with idiopathic slow-transit constipation refractory to conservative treatment

Phase 4

Completed

Conditions: Constipation
slow-transit constipation
10017977

Registration Number: NL-OMON50732

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 67

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
- Resistant to conservative treatment (i.e. an average DF of <3 per week and
meet at least one other criterion of the Rome-IV criteria despite maximal
conservative treatment. This means that the patient must have been resistant to
the following treatments: lifestyle changes, laxatives, enemas and retrograde
colonic irrigation)
- Age: 14-80 years
- Slow-transit constipation

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome is treatment success. Patients with an average defecation<br /><br>frequency (DF) of *3 a week are considered successfully treated. Patients with<br /><br>an average DF of <3 a week are considered not successfully treated. This is a<br /><br>clinically relevant outcome, consistent with the internationally widely<br /><br>accepted Rome-IV criteria for idiopathic constipation. DF will be measured<br /><br>using a defecation diary (DD) over a period of 3 weeks (patient-reported).</p><br>

Secondary Outcome Measures