Incontinence outcomes in women undergoing retropubic mid-urethral sling: a retrospective cohort study comparing Safyre™ and handmade sling

Terziotti, Fernando; Gregório, Emerson Pereira; Averbeck, Marcio Augusto; Almeida, Silvio Henrique Maia

doi:10.1590/S1677-5538.IBJU.2021.0646

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ORIGINAL ARTICLE • Int. braz j urol 48 (4) • Jul-Aug 2022 • https://doi.org/10.1590/S1677-5538.IBJU.2021.0646 copy

Incontinence outcomes in women undergoing retropubic mid-urethral sling: a retrospective cohort study comparing Safyre™ and handmade sling

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Purpose

This study examined and compared efficacy, safety, satisfaction, and complications of the retropubic Safyre™ sling and a retropubic hand-made synthetic sling (HMS) in a short-, mid- and long-term follow-up.

Methods

We retrospectively reviewed a prospectively maintained database of women who underwent Safyre™ or HMS between March 7^ths 2005 and December 27^ths, 2017. Patients had first assessment (7-10 days), second (40-45 days), and third (sixth month) postoperatively. Between September and December 2018, patients who completed at least one year of surgery, received a telephone call. Follow-up compared quartiles of follow-up time to determine complications (Clavien-Dindo), success rates (International Consultation on Incontinence Modular Questionnaire for Urinary Incontinence Short Form – ICIQ-UI SF), and patient satisfaction.

Results

Three hundred fifty-one patients underwent surgery and 221 (63%) were evaluated after a median of 78.47 (± 38.69) months, 125 (55%) in the HMS, and 96 (45%) in the Safyre™ group. Higher intraoperative bladder injury was observed with Safyre™ (0% vs. 4.2%, p=0.034), and a tendency for urinary retention, requiring indwelling urinary catheter over 24 hours (2.4% vs. 8.3%, p=0.061). Both HMS (p<0.001) and Safyre™ (p<0.001) presented improvements on ICIQ-UI SF. There were no differences in satisfaction, subjective cure rates, ICIQ-UI SF, or complications between groups.

Conclusions

Both HMS and Safyre™ have similar satisfaction and subjective cure rates, with marked ICIQ-UI SF score improvement. Higher rates of intraoperative bladder injury were seen in patients who received Safyre™ retropubic sling.

Urinary Incontinence; Suburethral Slings; Postoperative Complications

		HMS n=125 (56%)	Safyre™ n=96 (44%)	p-value
Age (years), mean (SD)		58.94 (±11.62)	60.33 (±12.26)	0.391^b
Concomitant surgery		33 (26.4%)	26 (27.1%)	0.909^a
BMI (kg/m ² ), mean (SD)		28.38 (±5.19)	27.69 (±4.64)	0.307^b
Hormonal Status	Menopause without HR	81 (64.8%)	48 (50.0%)	0.149^d
	Menopause with HR	18 (14.4%)	27 (28.1%)
	Premenopausal	26 (20.8%)	21 (21.9%)
Pads usage	Daily	50 (40.0%)	58 (60.4%)	0.004 ^a
	If necessary	25 (20.0%)	18 (18.8%)
	None	50 (40.0%)	20 (20.8%)
Preoperative ICIQ-UI SF, median (IR)		10 (9.0 – 11.0)	10 (9.0 – 12.0)	0.164^c
Parity, median (IR)	Pregnancies	3.0 (2.0 – 3.25)	2.0 (2.0 – 3.0)	0.156^c
	Normal birth	2.0 (0 – 3.0)	2.0 (0 – 3.0)	0.264^c
	Cesarean section	0 (0 – 1.25)	1.0 (0 – 2.0)	0.330^c
Previous surgeries	Incontinence	19 (15.2%)	17 (17.7%)	0.617^a
	Pelvic Organ Prolapse	39 (31.2%)	23 (24.0%)	0.235^a
	Hysterectomy	34 (27.2%)	26 (27.1%)	0.985^a
	Abdominal (others)	23(18.4%)	19 (19.8%)	0.794^a
VLPP (cmH ₂ 0), mean (SD)		103.48 (±38.01)	103.04 (±40.83)	0.934^b
Leakage type	Stress	111 (88.8%)	82 (85.4%)	0.453^a
Leakage type	Mixed	14 (11.2%)	14 (14.6%)
Post-voiding residual urine	<30mL	93 (74.4%)	82 (85.4%)	0.665^d
	30-100mL	21 (16.8%)	4 (4.2%)
	>100mL	11 (8.8%)	10 (10.4%)

		HMS n=125 (56%)	Safyre™ n=96 (44%)	p-value

Intraoperative bladder injury		0 (0.0%)	4 (4.2%)	0.034 ^e
Urinary infection		14 (11.2%)	10 (10.4%)	0.853^a
Vaginal bleeding		28 (22.4%)	18 (18.8%)	0.508^a
LIC>24h		3 (2.4%)	8 (8.3%)	0.061^e
Sling readjustment	None	118 (94.4%)	88 (91.7%)	0.434^e
	Tightening ^g	1 (0.8%)	2 (2.4%)
	Loosening ^g	3 (2.4%)	2 (2.1%)
	Urethrolysis ^h	3 (2.4%)	4 (4.2%)
6th month office reassessment
Stress Incontinence		12 (9.6%)	11 (11.5%)	0.654^a
Urgency Incontinence		23 (18.4%)	24 (25.0%)	0.235^a
Mixed Incontinence		5 (4.0%)	10 (10.4%)	0.060^a
Pain		24 (19.2%)	14 (14.6%)	0.367^a
Vaginal extrusion		16 (12.8%)	6 (6.2%)	0.107^a
Time (months), median (IR)		6.0 (2.0 – 12.0)	3.0 (2.0 – 4.0)	0.120^c
Treatment	None	109 (87.2%)	90 (93.7%)	0.118^e
	Topical	12 (9.6%)	4 (4.2%)
	Surgical	4 (3.2%)	2 (2.1%)
Clavien-Dindo	None	101 (80.8%)	83 (86.5%)	0.282^e
	II	4 (3.2%)	2 (2.1%)
	IIIa	5 (4.0%)	3 (3.1%)
	IIIb	15 (12.0%)	8(8.3%)

	HMS n=115 (56%)	Safyre™ n=92 (44%)	p-value
Deaths*	10 (8.0%)	4 (4.2%)	0.246^a
Loss of follow-up	58 (31.7%)	31 (24.4%)	0.163^a
Follow-up (months), mean (SD)	85.05 (±40.93)	69.90 (±33.90)	0.004^b
Postoperative ICIQ-UI SF, median (IR)	3 (0.0 –12.75)	3.5 (0.0 – 9.5)	0.476^c
ICIQ-UI SF dif (pre – post), median (IR)	6 (2 – 8)	6 (4 – 8)	0.142^c
De novo urgency	46 (40.0%)	39 (42.4%)	0.728^a
Urinary Tract Infection	20 (17.4%)	17 (18.5%)	0.839^a
Vaginal bleeding	3 (2.6%)	0 (0.0%)	0.256^e
Voiding symptoms	13 (11.3%)	4 (4.3%)	0.070^a
Pelvic pain	8 (7.0%)	5 (5.4%)	0.654^a
Dyspareunia	0 (0.0%)	3 (3.3%)	0.086^e
Satisfaction	91 (79.1%)	76 (82.6%)	0.529^a
Subjective Cure	79 (68.7%)	73 (79.3%)	0.085^a

	HMS

Follow-up (months)	Preoperative ICIQ-UI SF	Postoperative ICIQ-UI SF	p-value
13 – 42 (n=27)	9 (8.5 – 12)	0 (0 – 12)	0.002 ^f
43 – 79 (n=21)	10 (9 – 12)	9 (0 – 16)	0.163f
80 – 103 (n=28)	10 (9 – 10.5)	3 (0 – 13.5)	0.005 ^f
104 – 165 (n=39)	9 (8 – 12)	5 (0 – 13)	0.008 ^f

Total (n=115)	10 (9 – 11)	3 (0 – 13)	<0.001 ^f

	Safyre™

13 – 42 (n=24)	9.5 (8.25 – 11)	1.5 (0 – 8)	0.006 ^f
43 – 79 (n=31)	10 (8.5 – 13)	5 (0 – 13)	0.002 ^f
80 – 103 (n=24)	11 (8.5 – 13.5)	5 (0 – 8)	<0.001 ^f
104 – 165 (n=13)	9.5 (9 – 12.5)	3 (0 – 11)	0.007 ^f

Total (n=92)	10 (9 – 12)	3.5 (0 – 9.75)	<0.001 ^f

Follow-up (months)	HMS	Safyre™	p-value
ICIQ-UI SF difference (pre – post), median (IR)
13 – 42 (n=51)	8 (-2.25 – 9) (n=27)	7 (1.5 – 10) (n=24)	0.813^c
43 – 79 (n=52)	3 (-4.25 – 10) (n=21)	5 (-0.5 – 9) (n=31)	0.386^c
80 – 103 (n=52)	7 (-2.5 – 9) (n=28)	6.5 (2 – 10.5) (n=24)	0.138^c
104 – 165 (n=52)	6 (-3 – 9) (n=39)	6 (2.5 – 9) (n=13)	0.336^c
Satisfaction, n (%)
13 – 42 (n=51)	24 (89%)	22 (91.7%)	0.890^a
43 – 79 (n=52)	12 (57.2%)	27 (87.1%)	0.034 ^a
80 – 103 (n=52)	21 (75%)	18 (75%)	0.748^a
104 – 165 (n=52)	34 (87.2%)	9 (69.2%)	0.290^a
Subjective Cure, n (%)
13 – 42 (n=51)	21 (77.8%)	20 (83.3%)	0.884^a
43 – 79 (n=52)	14 (66.7%)	25 (80.6%)	0.414^a
80 – 103 (n=52)	19 (67.9%)	20 (83.3%)	0.335^a
104 – 165 (n=52)	25 (64.1%)	8 (61.6%)	0.868^a

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[1] Correspondence address: Marcio Augusto Averbeck, MD, PhD Departamento de Urologia, Hospital Moinhos de Vento Av Tiradentes 333, 6 andar (Videourodinamica) Porto Alegre, RS, Brasil Fax: + 55 51 3314-2940 E-mail: marcioaverbeck@gmail.com