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

Freeman 2011.

Methods RCT comparing TOT and TVT
Participants Multicentre RCT – 21 centres across the UK
192 women
Inclusion criteria: women >21 years of age; USI or MUI for which SUI was the predominant symptom; must have failed with conservative measures
Exclusion criteria: women with neurological disease; previous surgery for USI (those with previous prolapse surgery were not excluded); urodynamic DO or low compliance; POP extending beyond the hymen
Interventions Group A: Monarc TOT (n = 100)
Group B: Gynaecare TVT (n = 92)
Outcomes Follow‐up at 4 weeks, 6 months and 12 months

  • Subjective cure: self‐reported via response to ICIQ‐FLUTS questionnaire:

  • Mean operation time

  • Operative blood loss

  • Bladder perforation

  • Vaginal perforation

  • Tape erosion

  • Voiding dysfunction

  • De novo OAB

  • Groin pain

  • Sexual function: assessed via ICIQ‐LUTSqol scores.
Notes The trial was a non‐inferiority design. Outcome measures calculated by intention‐to‐treat
Assessed via ICIQ‐FLUTS long form, ICIQ
LUTSqol; KHQ questionnaires and 4‐day urinary diary
Sexual function assessed by ICIQ‐LUTSqol question, ‘does your urinary problem affect your sex life?’
Cystoscopy: not mentioned whether routinely performed in either group
Lost to follow‐up: Group A: 5/100; Group B: 7/92 (and 1 excluded as she did not have the operation)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomisation list was stratified by study sites, using
 randomly permuted blocks of varying sizes of 4, 6 and 8"
Allocation concealment (selection bias) Low risk Quote: "The study co‐ordinator placed a treatment into consecutively
 numbered opaque envelopes which were opened immediately before surgery by someone other than the surgeon. Allocation concealment was therefore ensured"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Patients and ward staff were blinded to the intervention group by ensuring that dressings were applied both suprapubically and to the obturator areas"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Patients and their data accounted for