This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 In a systematic review of 8 studies, the mean number of pads used per day reduced from a range of 4.1 to 5.4 at baseline to a range of 1.1 to 1.2 at 2‑year follow‑up. In a case series of 57 patients (also included in the systematic review), there was a statistically significant decrease in the mean number of pads used per day from 5.6 (±2.3) at baseline (n=57) to 0.4 (±0.8) at 72‑month follow‑up (n=29; p<0.001).
4.2 In a case series of 52 patients, 14% (7/52) of patients were fully continent and 25% (13/52) of patients reported more than 80% improvement at last follow‑up (median 10.5 months); 19% (10/52) of patients were still having successive balloon inflations. In the case series of 57 patients, 62% of patients reported that they were fully continent at last follow‑up (mean 72 months), 30% reported improvement of more than 50%, and 8% of patients reported no change or improvement of less than 50%. In a case series of 41 patients, 44% of patients were fully continent, 15% reported significant improvement, 29% reported slight improvement and 12% reported no change at last follow‑up (mean 25 months).
4.3 In a case series of 162 patients (also included in the systematic review), 51% and 76% of patients were fully continent (<2 g on a provocative pad test) at 1‑ and 5‑year follow‑up respectively. The mean provocative pad weight decreased for 85% (107/126) of patients, with a mean improvement from 49.6 g to 11.2 g (p<0.001) at 1‑year follow‑up.
4.4 In the case series of 162 patients, the mean Incontinence Quality of Life (IQOL) score improved from 36.8 at baseline to 71.1 at 1‑year and 74.3 at 5‑year follow‑up (p value not reported). In the same study, the mean Urogenital Distress Inventory (UDI) score improved from 60 at baseline to 37 at 1‑year and 51 at 5‑year follow‑up. In the case series of 57 patients, there was a statistically significant improvement in the mean IQOL score from 27.2 at baseline to 65.9 at 1‑year and 78.6 at 72‑month follow‑up (p<0.001 for both).
4.5 In the case series of 57 patients, there was a statistically significant increase in the mean Valsalva leak point pressure from 51 cmH2O at baseline to 86 cmH2O at 12‑month follow‑up (n=30; p<0.01). The mean urethral closure pressure increased from 47 cmH2O at baseline to 51 cmH2O at 12‑month follow‑up (n=30; p=not significant).
4.6 In the case series of 41 patients, explantation because of non-response was done in 15% (6/41) of patients.
4.7 The specialist advisers listed key efficacy outcomes as cure or improvement in urinary incontinence as measured by subjective outcome measures (validated questionnaires), and objective measures (pad tests and urodynamics).