Secca System for faecal incontinence

Study component

Description

Objectives/hypotheses

To evaluate the clinical response and sustainability of Secca Therapy for faecal incontinence.

Study design

Prospective single-arm study.

Setting

Secca treatments done at a single centre (Netherlands) between 2005 and 2010.

Inclusion/exclusion criteria

Inclusion criteria: patients with a VS ≥12, whose condition had not improved with conservative treatment (including physiotherapy for 3 months).

Exclusion criteria: significant comorbidities (undefined), diarrhoea, large sphincter defect (>25% circumference), inflammatory bowel disease, relevant surgical history (low anterior resection, Pelvicol implantation), rectocele, proctitis and anal atresia.

Primary outcomes

VS at 6, 12 and 36 months (a clinically significant improvement was defined as ≥50% reduction in VS).

FIQL.

Secondary outcomes: anorectal manometry, rectal compliance, adverse events, procedural tolerability.

Statistical methods

Differences were analysed using a paired t-test or Wilcoxon rank test when a non-Gaussian distribution was present. The independent t-test was used to compare patients with and without a response. The Fisher's exact test was used to compare proportions. A p-value <0.05 was considered to be statistically significant.

Patients included

Total cohort n=31 consisting of a cohort of 11 patients previously reported (Felt-Bersma et al. 2007) and 20 additional patients.

Results

Significant improvement in VS at 6 months. No significant improvement in VS at 12 and 36 months when compared with VS at 6 months, after Secca Therapy.

Significant improvement in FIQL Scale coping subscore only (no significant change in lifestyle, depression and embarrassment subscores) at 6 months. No significant improvement in FIQL Scale subscores between 6, 12 and 36 months after Secca Therapy.

No significant change in anorectal manometry and rectal compliance at 3 months. No differences in anorectal function between patients with and without a clinical response were found.

Conclusions

The authors concluded that these were disappointing outcomes for the Secca procedure, with clinically significant responses being of a temporary nature.

Abbreviations: FIQL, Faecal Incontinence Quality of Life; n, number of patients; VS, Vaizey score.

Baseline: before Secca

Follow‑up: after Secca

Analysis

Efficacy

n=31^a

n=31^a

Primary outcome: VS (mean±SD)

18±3

6 months:

14±5

p<0.001

At 6 months, 5 patients (16%) showed a ≥50% decrease in VS, and 12 patients^b (38%) showed a ≤20% decrease in VS.

At 12 months, 3 patients (10%) showed a ≥50% decrease in VS compared with baseline.

At 36 months, 2 patients (6.5%^b) showed a ≥50% decrease in VS, and 6 patients^b (19%) showed a ≤20% decrease in VS compared with baseline.

Comparison of VS at 12 and 36 months (compared with 6 months) showed no significant improvement over time.

Selected secondary outcomes

FIQL (median):

NR

1.5±0.5

NR

NR

6 months:

NR

1.9±0.7

NR

NR

p=NS

p=0.008

p=NS

p=NS

Comparison of FIQL subscores at 12 and 36 months (compared with 6 months) showed no significant improvement over time.

Anorectal function

NR

NR

No significant difference in anorectal function between patients with and without a clinical response – defined as patients with a decrease in Vaizey score greater or equal to 20% – at 6 months.

Maximal basal pressure (mean±SD, mmHg)

43±14

3 months:

40±16

p=0.07

Maximum squeeze pressure (mean±SD, mmHg)

22±10

3 months:

24±11

p=0.13

Threshold volume of initial rectal sensation (mean±SD, ml)

78±43

3 months:

79±40

p=0.91

Urge to defecate (mean±SD, ml)

136±57

3 months:

132±53

p=0.62

Maximum rectal distention (mean±SD, ml)

188±12

3 months:

180±11

p=0.43

Additional interventions

None of the 31 patients had any additional surgical intervention after Secca Therapy.

Safety

n=31

Adverse events

Minor bleeding or haematoma (n=8)

Antibiotic-related diarrhoea (n=7)

Urinary tract infection (n=1)

Temporary discharge of mucus (n=1)

No long‑term complications were reported

Tolerability: Pain VAS (mean [range], cm)

3.9 (0–10) during procedure

3.3 (0–9) after 1 week

1.2 (0–6) after 3 weeks

Abbreviations: FIQL, Faecal Incontinence Quality of Life; ml, millilitres; n, number of patients; NR, not reported; NS, not significant; SD, standard deviation; VAS, visual analogue scale; VS, Vaizey Score.

^a Includes 11 patients from the Felt-Bersma et al. (2007) study.

^b Number of patients calculated by the authors of this briefing.