Of 344 subjects who enrolled in the study we present safety and efficacy data on 177 patients who have reached a minimum follow up of 8 years. Mean age of the patients was 61,8 years, 40% of them also had a diagnosis of urge incontinence. Mean ICIQ 16,5, Sandvik 6,51 and EVA 7.52.
A total of 158 of the patients (89,2%) achieved subjective cure of stress incontinence (95% Confidence Interval), 143 patients (80,79%) achieved objective cure (95% Confidence Interval), 18 patients ( 10,16%) improved and 16 patients ( 9,03%) were not objectively cured. Mean EVA of the affects: 4.78. ICI-Q 2,14 and Sandvik Test 0.6. Mean operating time was 7 min. 8 patients had de novo urge incontinence (3,39%).
Patient demographics and clinical characteristics are reported in Table 1
Data analysis reported in table 2
Table 1
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Age (years) 61,8 (42-81)
Parity 2,56 (0-8)
Evolution (years) 8,3 (1-25)
BMI (Kg/m2) 28,7 (18-43)
Occult SUI (% (patients)) 21,46% (38)
IUU (% (patients)) 29,37% (52)
POP associated surgery (% (patients)) 33,89% (60 )
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Table 2
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Operative time (min) 8 ( 6-20)
Hospital stay (days) 1,1 (0,5-3)
Intra-operative complications 44 patients (24,85%), all involving bleeding:
- 33% lower than 50ml
- 64% 50-200ml
Immediate post-operative 12 patients (6,77%):
complications - 3 (1,69%) acute urinary retention,
- 1 ( 0,56%) severe pain,
- 4 (2,25%) urinary infections
- 4 (2,25%) mild hematoma.
Improve (% (patients)) 10,16% (18patients)
Failure (% (patients)) 9,03% (16patients)
Objective cure (% (patients)) 80,79% (143)
Subjective cure: 89,26% (95 CI)
Preoperative Postoperative
Sandvik 6,8 (2-12) 0,6 (0-6)
ICIQ (QoL) 16,5 (4-21) 2,14 (2-14)
IU “de novo” (% (patients)) 4,51% (8)
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