Carr 2017.

Methods	Study design: RCT Dates study conducted: between February 2012 and January 2015
Participants	Setting: tertiary care centre Total number of participants: 143 Sex: female Number of women eligible for review: 2 participants had previously undergone TVT/TOT, as reported in the conference abstract (Ismail 2017). Inclusion criteria: women with predominant SUI who experienced ≥ 3 stress incontinence episodes in 3 days
Interventions	Group I (n = 50): vehicle placebo Group II (n = 93): Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC‐USR) Randomisation was 2:1 to receive intrasphincteric injection of 150 x 106 AMDC‐USR or vehicle placebo and 1:1 to receive 1 or 2 treatments. Second treatments were administered 6 months after first treatments. Intrasphincteric injections were administered at 9 circumferential locations; re‐injections were undertaken at 6 months.
Outcomes	The primary composite endpoint was the percentage of participants with ≥ 50% reduction in incontinence episode frequency (IEF) from a 3‐day diary or ≥ 50% reduction in either 24 hour or in‐office pad test 12 months post‐treatment. No secondary outcomes were defined, although the authors used alternative outcomes in a post‐hoc analysis in an effort to show a reduced placebo effect.
Notes	Follow‐up: for 2 years after initial treatment (141 participants completed their 12‐month visit and 127 completed the 2‐year visit). Recruitment halted prematurely in view of high placebo response rate. We are aware that there is a full report of this study published after the search date for this review. Authors were contacted for additional information regarding population of interest on 27 November 2018; no response was obtained by 25 February 2019 (Hilton 2018 [pers comm]).

AMDC‐USR = Autologous Muscle Derived Cells for Urinary Sphincter Repair
 IEF = incontinence episode frequency
 RCT = randomised controlled trial
 SUI = stress urinary incontinence
 TOT = transobturator tape
 TVT = tension‐free vaginal tape