Randomization
Arm A · n = 149
Pessary
Continence ring or dish pessary, fitted by physician/nurse
Arm B · n = 146
Behavioral
4 visits, pelvic floor muscle training + exercises + skills
Arm C · n = 151
Combined
Both pessary and behavioral therapy
Primary Outcomes at 3 Months (ITT)
| Outcome |
Combined |
Behavioral |
Pessary |
Key P-values |
| PGI-I “much/very much better” |
53.3% |
49.3% |
39.6% |
Comb vs Pes P=0.02; Beh vs Pes P=0.09 |
| No bothersome SUI (PFDI) |
44.0% |
48.6% |
32.9% |
Beh vs Pes P=0.006 |
| ≥75% UI reduction |
53.3% |
46.7% |
46.3% |
NS |
| Satisfaction |
78.7% |
75.3% |
63.1% |
Beh vs Pes P=0.03 |
A priori superiority criterion: Combination therapy was required to be better than BOTH single-modality therapies to be considered superior — it was not. Combined vs. Behavioral was not significantly different on any measure.
12-Month Outcomes: All Groups Equalize
PGI-I “much/very much better” — all ~32%
No bothersome SUI (PFDI) — all ~35–40%
Dropout: Pessary dropout was higher (26%) than behavioral (15%) or combined (12%) at 3 months (P=0.015). Main reason: inadequate pessary fit (8.1%).
Clinical Bottom Line
Behavioral therapy produces modestly better short-term outcomes than pessary for SUI (more satisfaction, fewer bothersome symptoms at 3 months), but by 12 months all groups equalize. Combination therapy offers no advantage over single-modality treatment. Both are reasonable first-line non-surgical options — choice should be individualized.