title: Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up.
abstract: BACKGROUND
  Contemporary surgical treatment of female stress urinary incontinence (SUI) includes retropubic and transobturator (TO) midurethral slings (MUS). Case series of single-incision slings (SIS) have shown similar outcomes with lower morbidity.
  
  
  OBJECTIVE
  Our aim was to assess the cure rates, complications, and quality-of-life impact of one standard TO MUS and two SIS.
  
  
  METHODS
  Ninety consecutive patients with clinically and urodynamically proven SUI were enrolled in an exploratory randomised phase 2 trial. Patients with previous SUI surgery, major pelvic organ prolapse, mixed incontinence, or detrusor overactivity were excluded.
  
  
  METHODS
  Patients were treated randomly with TVT-O, TVT-Secur, or Mini-Arc.
  
  
  METHODS
  Postoperative visits were scheduled at 6 and 12 mo. The King's Health Questionnaire (KHQ) was repeated at 6 mo. Cure was defined as the absence of urine leakage, no pad use, and a negative cough test at 12 mo. Pain and other complications were also investigated.
  
  
  CONCLUSIONS
  Cure rate was 83% after TVT-O, 67% after TVT-Secur, and 87% after Mini-Arc. Improvement was found in 10%, 13%, and 7% of the patients, respectively. Failures were 7% after TVT-O and Mini-Arc and 20% after TVT-Secur. TVT-O and Mini-Arc improved at least 15 points in >80% of the patients in six KHQ domains, whereas TVT-Secur could only achieve improvement in three of the nine domains. The pain score was lower in the Mini-Arc group. Complications were more numerous after TVT-O. This study has the limitations inherent in a phase 2 trial with a follow-up limited to 12 mo.
  
  
  CONCLUSIONS
  Mini-Arc offers cure and improvement rates similar to TVT-O, whereas TVT-Secur may yield an inferior outcome. These findings recommend the urgent launch of large randomised phase 3 studies comparing conventional MUS with SIS, with Mini-Arc the advised option.
authors.affiliation: Hospital de São João, Serviço de Urologia, Porto, Portugal.
authors.forename: Rui
authors.initials: R
authors.lastname: Oliveira
authors.forename: Francisco
authors.initials: F
authors.lastname: Botelho
authors.forename: Pedro
authors.initials: P
authors.lastname: Silva
authors.forename: Alexandre
authors.initials: A
authors.lastname: Resende
authors.forename: Carlos
authors.initials: C
authors.lastname: Silva
authors.forename: Paulo
authors.initials: P
authors.lastname: Dinis
authors.forename: Francisco
authors.initials: F
authors.lastname: Cruz
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D011174:Portugal; D011474:Prosthesis Design; D011788:Quality of Life; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation*