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Multicenter study for the surgical treatment of stress urinary incontinence en women

Baya G1, Janin P2, Navazo R3

1. Althaia. Xarxa Assistencial De Manresa. Hgm. Manresa. Spain,

2. CLINIC POLE SANTE LEONARDO DA VINCI, TOURS, France,

3. UNIVERSITY HOSPITAL CLINICO SAN CARLOS, Madrid, Spain

MULTICENTER STUDY FOR THE SURGICAL TREATMENT OF STRESS

URINARY INCONTINENCE IN WOMEN WITH A SINGLE INCISION TOT

TECHNIQUE. TWO YEARS FOLLOW UP.

 

Hypothesis / aims of study

 

The aim of the present study is to evaluate safety and efficacy of a new tension-free procedure (CONTASURE

NEEDLELESS) for the surgical treatment of SUI in female, and to review our data in patients with a minimum follow up of 2

years. Our goal is to simplify the TOT technique since only a single incision is needed to perform this procedure. 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.

Study design, materials and methods

A prospective multicenter study was carried out in 345 patients with SUI. Subjects were evaluated under a clinical study

protocol consisting in a urogynecology clinical history, quality of life questionnaire, (preoperative ICI-Q (QoL): 7.45 (4-21)

and Sandvick Test: 6.8 (2-12)), the clinical classification under Ingelman-Sundberg, urethral mobilization study with Q-tip test

and urodynamic study. Subjects with ISD and recurrent urinary incontinence were excluded.

Surgical technique consist of placing under the midurethra a macroporus monofilament polypropylene sling of 11,4cm.

length and 1,4cm. wide, with a Pocket Positioning System that allows to anchor the sling. Local or spinal anesthesia was

used. After applying anesthesia, a longitudinal 1,5 cm incision is made in the anterior vaginal wall. Dissection of the

paraurethral spaces is performed up to de ischiopubic ramus. Kelly clamp is introduced in the Pocket System at the edge of

the mesh, and introduced through the dissected spaces perforating the fascia of the Internal Obturator muscle.

 

Results

 

Of 345 subjects who enrolled in the study we present safety and efficacy data on 169 patients (Mean age of the patients was

63,2 years (42- 81); parity: 2.8 (2-7) who have reached a minimum follow-up of 2 year. After a mean follow-up period of

24 months, 144 patients (85,2%) achieved cure of stress incontinence (objective and subjective), 13 of them (7,69%)

improved. A total of 12 patients (7,1%) were not objectively cured. Mean operating time was 7 min (range 4 -20). ICI-Q

(QoL) 1.9 (0-14) and Sandvick Test 0.6 (0-6).One bladder perforation was described, no other intraoperative complications

occurred. No urinary retentions during immediate post operative happened. One patient had a mild hematoma. Mean

hospital staying was 1.1 days (range 0.5-3). There were no cases of grin pain. As late complications there were 5 partial

mesh erosion (2,95%), 4 of them solved with local estrogens, and 1 in treatment with local estrogens. Two patients had de

novo urge incontinence. Six patients had UUI in treatment with anticolinergics.

 

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 midurethral synthetic sling placement of Needleless is reproducible, easy to

master, and minimally invasive with respect to other tension free procedures. Patient surgical morbidity decreases with this

technique with less peri operative and post operative complications.

Two year follow up results are the same that other tension free procedures(TVT/ TOT), and no change in success rates

regarding 1 year follow up cases (245 patients),are observed (2, 3). Further experience to have a clear view of mid term

results, and further studies with longer follow up are needed.

 

 


Baya G; Janin P; Navazo R

San Francisco

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