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

Abdel‐Fattah 2010.

Methods RCT of TVT‐O vs TOT–ARIS
Participants 341 women from the west of Scotland, UK, Urogynaecology tertiary referral centre
Inclusion criteria: women with USI or MUI (but with SUI as the predominant troublesome symptom). Women with previous incontinence surgery were included. All women had failed or declined pelvic floor muscle training
Exclusion criteria: predominant OAB symptoms; or had specific co‐morbidities such as known neurological conditions (e.g. multiple sclerosis); diabetes; ≥ stage 2 POP‐Q or concomitant surgery, or both
There were no significant differences in participant characteristics between the 2 groups
Mean age (years): Group A: 51.5; Group B: 52.1
Mean BMI kg/m²: Group A: 28.1; Group B: 28.9
MUI: Group A: 40/170; Group B: 43/171
Previous incontinence surgery: Group A: 28/170; Group B: 18/171
Interventions Group A: TVT‐O (n = 170)
Group B: TOT (n = 171)
Outcomes Primary outcome: absence of USI on UDS
Secondary outcome measures:
  • patient‐reported success rates on the PGI‐I

  • objective cure (ICS 1‐hr pad test)

  • subjective success on PGI‐I

  • bladder/urethral perforation

  • voiding dysfunction

  • tape erosion

  • groin pain

  • repeat continence surgery

  • QoL assessed via: KHQ, Birmingham Bowel Urinary Symptom (BBUSQ‐22)and PISQ‐12. In addition PGI‐I and ICIQ‐SF questionnaires.

  • sexual dysfunction: PISQ‐12 employed

  • intermediate (3 year) subjective success on PGI‐I

Notes Loss to follow up at 1 year: Group A: 18/170, Group B: 24/171
Loss to follow up at 3 years: Group A: 44/170, Group B: 59/171
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A single‐blinded, prospective, randomized study … Women were assigned to either procedure by random allocation (computer generated)"
Allocation concealment (selection bias) Low risk Quote: "Allocation was concealed using opaque sealed envelopes, which were opened by the nursing staff on the morning of the operation"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: “a single‐blinded, prospective, randomized study… Women were informed about the type of operation if they wished, for ethical considerations, but they were instructed not to disclose this information to the clinician at follow‐up”
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “Post‐operative assessment at 6 months was performed by an independent clinician who was blinded to the type of surgery … “
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: “No woman assigned to an arm asked to change her operation or to withdraw from the study prior to the operation. Withdrawals, unattendants and untraceables were accounted for without significant inter group differences”