Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial.
OBJECTIVE
To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.


METHODS
This prospective single-center randomized controlled trial involved 130 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.


RESULTS
Sixty-four patients in the mini-sling group and 56 in the transobturator group completed the 12-month follow-up. The objective cure rates for the mini-sling and the transobturator sling were 68.1% and 81.9% (absolute difference 13.8; 90% confidence interval [CI] 1.5-26.1; P=.439) and the subjective cure rates were 81.1% and 88.5% (absolute difference 7.4%; 90% CI 2.8-17.6; P=.110), respectively. There was a significant improvement in quality of life in both groups. Thigh pain was greater after the transobturator sling, four patients (7.1%) compared with zero (P=.045). The mean operation time was 5 minutes shorter for the mini-sling procedure (P=.000). Five patients (7.8%) in the mini-sling group and one patient (1.8%) in the transobturator group underwent surgical reintervention for persistent SUI (P=.213).


CONCLUSIONS
The noninferiority of the mini-sling could not be demonstrated in this study at the 12-month follow-up. The mini-sling was associated with shorter operative time and less postoperative thigh pain.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094353.
Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.
Lucyana M
LM
Djehdian
Maita P
MP
Araujo
Claudia C
CC
Takano
Carlos A
CA
Del-Roy
Marair G F
MGF
Sartori
Manoel J B C
MJBC
Girão
Rodrigo A
RA
Castro
D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008875:Middle Aged; D061646:Operative Time; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011788:Quality of Life; D012086:Reoperation / Q000706:statistics & numerical data; D053825:Suburethral Slings; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*