8 YEARS FOLLOW UP FOR THE SURGICAL TREATMENT OF STRESS URINARY INCONTINENCE IN WOMEN WITH A SINGLE INCISION TOT TECHNIQUE.

BAYA G1, AMELA A2, MISERACHS M3, MALDONADO A2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 348
E-Poster 2
Scientific Open Discussion Session 18
Thursday 5th September 2019
13:20 - 13:25 (ePoster Station 6)
Exhibition Hall
Stress Urinary Incontinence Surgery Grafts: Synthetic Female Prospective Study
1.FUNDACIO ALTHAIA MANRESA BARCELONA, 2.FUNDACIO ALTHAIA MANRESA ( BARCELONA), 3.FUNDAICO ALTHAIA MANRESSSA (BARCELONA)
Presenter
G

Gonzalo Baya

Links

Abstract

Hypothesis / aims of study
Although in 2013 the FDA website state that:  “The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year”, and the AUGS/SUFU, IUGA and other scientific associations joint statement in strong support of  the mid-urethral sling (MUS) there is a negative perception of the mid-urethral sling , due to multimedia attention that has  resulted in confusion, fear, and an unbalanced negative perception regarding the mid-urethral sling as a treatment for SUI. 
The aim of the present study is to evaluate long term follow up safety and efficacy of a tension-free procedure (CONTASURE NEEDLELESS) for the surgical treatment of stress urinary incontinence (SUI) in female, and to review our data in patients with a minimum follow up of eight years.
Study design, materials and methods
A prospective study was carried out in 344 patients with SUI since 2007. Subjects were evaluated under a clinical study protocol consisting in a urogynecology clinical history, quality of life evaluation with QoL questionnaire, ICI-Q and Sandvik Test and urethral mobilization study (Q-tip test,ultrasound hypermobility, urodynamic study). Subjects with ISD were excluded.

Needleless® sling is a macroporous monofilament polypropylene mesh of 11,4cm length and 1,4cm wide with a Pocket Positioning anchorage System (PPS). The surgical technique consists in placing de sling under the mid urethra. Starting with a longitudinal 1,5cm midline incision in the anterior vaginal wall a blunt dissection of the paraurethral spaces up to the ischiopubic ramus is performed. The sling is introduced with a Kelly clamp in the PPS through the dissected spaces and penetrate at 45º from the horizontal plane perforating the fascia of the internal obturator muscle. Once in place, PPS is open.With this technique we avoid the major complications during surgery (TVT/TOT), when passing the needle via the transobturator route but keeping the Tension Free concept.
Results
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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Interpretation of results
Although complications with all anti-incontinence procedures exist, understanding the anatomical considerations and methodology of this unique procedure should minimize patient morbidity.
Concluding message
The present data suggest that the technique of mid-urethral synthetic sling placement of Needleless is reproducible, easy to master, and minimally invasive. Eight years follow up results are the same that other tension free procedures(TVT/ TOT), and no change in success rates regarding three and five year follow up cases are observed. Further studies with larger number patients are needed. Patient surgical morbidity decreases with this technique with less peri-operative and post operative complications.
References
  1. Trabuco et al. Overview of transvaginal placement of mesh for prolapse and stress urinary incontinence. Uptodate April 2017.
  2. Fu et al. The clinical efficacy of needleless sling technique and TOT in the treatment of female stress urinary incontinence: a prospective randomized controlled trial. Int J Clin Exp Med 2017;10(4):7084-7090 3.
  3. Amat i Tardiu et al. Contasure-Needleless® compared with transobturator-TVT® for the treatment of stress urinary incontinence. Int Urogynecol J, March 2011
Disclosures
Funding none Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee FUNDACIO ALTHAIA MANRESA ETHICS COMMITTEE Helsinki Yes Informed Consent Yes
28/03/2024 01:32:52