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. 2017 Jul 31;2017(7):CD006375. doi: 10.1002/14651858.CD006375.pub4

El‐Hefnawy 2010.

Methods RCT comparing Gynecare TVT R and Aris TOTR outside‐in
Participants 40 women
Inclusion criteria: women with urodynamically proven SUI
Exclusion criteria: women who reported urgency incontinence as predominant complaint; had pelvic or vaginal surgery within the preceding 6 months; had associated urethral and/or bladder pathology or active UTI; neuropathic bladder; POP > stage 2 (Baden Walker classification)
Mean age (years; SD): Group A:47 (5); Group B: 45 (7)
Concomitant POP stage 1‐2: Group A: 10; Group B: 13
Mean BMI kg/m² (SD): Group A: 34 (5); Group B: 32(5)
Interventions Preliminary results:
Group A: TVT: (n = 19)
Group B: TOT: (n = 21)
At 24 months:
Group A: TVT: (n = 45)
Group B: TOT: (n = 42)
Outcomes Follow‐up at 3, 6, 12 and 24 months

  • Objective cure: negative stress test, 1‐h pad test <2g, and no re‐treatment for stress incontinence

  • 12 months negative stress test

  • 24 months negative stress test

  • 24 months negative 1hr pad test

  • Subjective cure: no reported SUI

  • Mean operative time

  • Mean blood loss

  • Vascular injury

  • Bladder injury

  • Groin pain (no report of suprapubic pain)

  • Tape erosion

  • De novo urgency

  • QOL measured using UDI‐6 and IIQ‐7 at baseline, 12 and 24 months
Notes Intraoperative cystoscopy carried out only in the TVT group to exclude bladder or urethral injury
Concomittant surgery was performed in 9 participants; 5 participants underwent abdominal hysterectomy, 4 participants underwent anterior colporrhaphy
Lost to follow‐up at 12 months: Group A: 0/19; Group B: 0/21
Lost to follow‐up at 24 months: Group A: 9/45; Group B: 7/42
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patient’s randomisation is accomplished through closed envelopes. A randomly selected envelope is dispatched to a running nurse with the patient’s name and ID hand typed on the envelope"
Allocation concealment (selection bias) Low risk Quote: “randomisation is accomplished through closed envelopes. A randomly selected envelope is dispatched to a running nurse with the patient’s name and ID hand typed on the envelope”
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “Follow up was carried out by a nurse blinded to the procedure”
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All outcomes included