Appendix to Full Application of SIMS Trial
Contents
A1 Example simulation code for sample size calculation
A2 Intervention details
A3 Home cough stress test
A4 SMS messaging
A1.
capture program drop testsim
program define testsim, rclass
version 11.0
drop _all
set obs 800 /*create a trial with obs number of patients patients*/
gen group=mod(_n,2) /* group either 1 or 0*/
gen pi = 0
gen temp0 = uniform() if group == 0
gen temp1 = uniform() if group == 1
replace
pi = 1 if temp0 <= 0.85 | temp1 <=0.85
/* these are the
proportions to change*/
cs pi group, or /* epi table from stata gives rd and or*/
return scalar lb_rd = r(lb_rd) /*gets the rd and the bounds for the ci*/
return scalar ub_rd = r(ub_rd)
return scalar rd = r(rd)
end
set more off
set seed 12345
quietly simulate lb_rd = r(lb_rd) ub_rd = r(ub_rd) rd = r(rd) , reps(1000): testsim
A2.
Adjustable single-incision mini-slings (SIMS)
All procedures done under LA will follow the LA protocol developed by our group in
conjunction with 2 consultants anaesthetists in Grampian NHS; the LA protocol has been
shown to be of proven efficacy in 2 previous studies of Adjustable SIMS. The protocol
was published in BJUI 2011 and includes:
 All participants would receive preoperative analgesia (30-45 minutes prior to
the operation; 100mg Diclofenac Sodium PR or 1 gm Paracetamol PR.
 All participants receive a vaginal application of “EMLA cream (A 5%
emulsion preparation, containing 2.5% each of lidocaine/prilocaine”) & 5ml of
intra-urethral Instillagel – (anaesthetic, antiseptic lubricant) 30 minutes prior
to the operation.
 Participants can receive an optional dose of 5 - 10mg diazepam (30 minutes
before the operation) to relieve anxiety and if not contra-indicated.
 Infiltration of LA: a mixture of Lignocaine 1% (max dose 2mg/kg bodyweight
or 3.5mg/kg) and Levo-bupivacaine (2.5mg/ml chirocaine, max dose 1mg/kg)
or Bupivacaine 0.25% with adrenaline 1:200,000 (Carbostesin, max dose
1mg/kg).
 LA will be infiltrated peri-urethrally (using 25 gauge needle), into the vaginal
angles & behind the inferior pubic ramous (using 21 gauge needle). Using a 22
gauge curved spinal needle to pass behind inferior public ramus; LA will be
infiltrated into the obturator membrane/muscles.
 Participants will be accompanied by a nurse for support and recording intraoperative pain scores.
All participating surgeons will use an adjustable SIMS that would meet the criteria
described above. A standardised insertion technique will be used by all surgeons strictly
following the original insertion description of the Adjustable SIMS used. They all,
however, have a fairly similar procedure of insertion. We describe below the standard
insertion steps for an adjustable SIMS (Ajust-CR Bard):
 Patients positioned in Lithotomy position with hips flexed at 90-100 degree.
 Cleaning & Draping & Catheterization (size 14 catheter) following 5 mls of
“Instillagel®” then block the catheter.
 Infiltration of LA as per protocol.
 Bilateral para-urethral tunnels created reaching to the posterior margin of the
inferior pubic ramus but without piercing the Obturator membrane.
 Adjustable SIMS “Ajust” tape, with the “fixed anchor” end mounted on the
applicator and secured using the anchor-release lever (retracted downwards),
would be introduced through the pre-dissected para-urethral tunnel until
reaching behind the inferior pubic ramus.
 The applicator would be then be introduced gradually with a pivot motion
behind the ramus and through the Obturator internus muscle and membrane
until the midline indicator on the tape (marked in blue) is at the level of the
urethra or slightly passed it.
 The anchor – release lever would then be released (pushed forward) allowing
the fixed anchor to maintain its position in the Obturator membrane.
 The applicator would then be withdrawn in a reverse motion to the
introduction.
 Trocar insertion steps would be repeated on to the other side allowing the
“adjustable anchor” to be fixed in the Obturator membrane.
 SIMS would then be adjusted securing a tension free adjustment.
 Cystoscopy; following another 10 mls of “Instillagel®” to ensure bladder
integrity.
 The “Stylet” would then be introduced through the adjustable tap and lock the
adjustable anchor securing its place. The adjustable mesh would then be
trimmed and the vagina closed with Vircyl 2-0.
 100 mls of water may be left in the bladder to facilitate voiding assessment.
 No vaginal packs or catheters would be routinely kept in situ.
Standard tension-free mid-urethral slings (SMUS)
A. Retropubic Tension Free Vaginal Tape (RT-TVT):

RT-TVT will be Type-1 polypropylene Mesh: mono-filament & macro-porous (pore
size ≥75 um).
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All procedures will be performed under GA or local anaesthesia & deep IV
sedation as originally described
 Cleaning, draping, insertion of 5cm of intra-urethral “Instillagel®” &
Catheterisation
 Close to the superior rim of the pubic bone, two 1cm long transverse incisions
3cm either side of the midline are made after injection of local anaesthetic.
 60-70 mls of local anaesthetic (Prilocaine & adrenaline 0.25%) is injected in
the abdominal skin just above the symphsis pubis and down along the back of
the pubic bone to the space of Retzius.
 Vaginally 40mls of prilocaine & adrenaline 0.25%, is injected into the vaginal
wall sub and paraurethrally.
 An incision ≤ 1.5 cm long is made in the midline of the suburethral vaginal
wall, starting 0.5 cm from the outer urethral meatus.
 Laterally from this incision a blunt dissection 0.5 -1 cm long is made with the
scissors either side of the urethra to allow introduction of the TVT ® needle.
 A stent is inserted into the Foley catheter to deviate the urethra-vesical
junction away from the path of the needle.
 The TVT needle perforates the urogenital diaphragm and is brought up to the
abdominal incision “shaving” the back of the pubic bone.
 The procedure is then repeated on the other side.
 Cystoscopy is performed to exclude perforation,
 Cough test is discretionary depending on surgeon practice.
 The sling is only loosely placed without elevation. The plastic sheath which
covers the tape is then removed, the tape is trimmed at the abdominal incisions
and the incisions are closed.
 Ulmsten et al recommend that a size 7 Hegar dilator is insterted into the
urethra to check the “proximal urethra and bladder neck has an acceptable
lumen and mobility”
 Vaginal & Skin incisions closed
 100 mls of water may be left in the bladder to facilitate voiding assessment.
 No postoperative vaginal packs or catheters would be routinely inserted.
B. Transobturator Tension Free Vaginal Tape (TO-TVT):
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TO-TVT will be Type-1 polypropylene Mesh: mono-filament & macro-porous (pore
size ≥75 um).
All procedures will be performed under GA as originally described.
Patients positioned in Lithotomy position with hips flexed at 90-100 degrees
Cleaning, draping, insertion of 5cm of intra-urethral instellagel &
Catheterisation
Local Anaesthesia infiltration will be infiltrated into the vaginal angles
(similar dose to SIMS insertion for standardisation).
1 cm sub-urethral longitudinal vaginal incision will be made starting 1 cm
below the urethral orifice.
Bilateral para-urethral tunnels created reaching to the posterior margin of the
inferior pubic ramus but without piercing the Obturator membrane in case of
“outside-in TO-TVT”.
Bilateral groin incisions are made 1cm lateral to the labio-femoral fold and 2
cm above level of urethra.
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The transobturator trocar is inserted from groin incisions at 90 degree to pierce
the obturator muscles and membranes and then guided by the surgeon finger to
the vaginal incision.
TO-TVT is then mounted on the trocar and the trocar is withdrawn in reverse
order.
The previous 2 steps are repeated on the contra-lateral side achieving TO-TVT
placement.
TO-TVT is then adjusted tension free
For the inside-out technique of insertion, TO-TVT would be introduced in the
reverse route from the vaginal incision towards the groin using the winged
guide.
Cough test is discretionary depending on surgeon practice.
Cystoscopy will be used to ensure bladder integrity
Vaginal & Skin incisions closed
100 mls of water may be left in the bladder to facilitate voiding assessment.
No postoperative vaginal packs or catheters would be routinely inserted.
A3
Home cough stress test compared to 24 hours pad test
24-hours pad test is a reliable and validated tool for objective measurement of UI and
is commonly used for outcome assessment in interventional surgical trials of urinary
incontinence. (1) Compared to urodynamic investigations, pad tests are generally
considered as non-invasive and quite simple assessment to perform (2). Many pad
tests (2min, 1 hour, 12 hours, 24 hours & 72 hours) have been described; the longer
the duration of the pad test the more likely to be reliable and accurate with good
reproducibility (1, 2). However, longer duration pad test are also associated with poorer
patient compliance and tolerance (3). The recent International urogynaecology
association recommendations (IUGA) (4) highlight the 24-hours pad test to be a useful
and accurate research tool for evaluation of outcomes following SUI treatment. The
test involves women wearing an incontinence pad for 24 hours and returning them,
within 72 hours, in pre-paid water proof packages to the trial office for weighing. This
allows for accurate quantification of urine loss and can be used to assess the efficacy
of treatment. However, this process is expensive and suffers from poor patient
compliance and more importantly some participants may find the whole process
unpleasant.
Clinician-observed cough stress test is widely used in Continence clinic during
clinical examination of women with UI and also as an assessment tool following
surgical or conservative treatment. Clinician-observed cough stress test has been
shown to be of proven test-re-test reliability (5) and has demonstrated good sensitivity
and specificity in the diagnosis of stress urinary incontinence, with accurate and
predictive results (6, 7). Furthermore, it is simple and non-invasive test with good
patient tolerability. However, being clinician observed, it can be associated with a
level of patient embarrassment; can be seen by a percentage of patients as time
consuming and require a clinic visit with all its associated NHS/ research costs
We hypothesize an alternative test of “home cough stress test” which has the potential
to overcome the above problems: it is an easy test to perform; done at the convenience
of patient home and privacy; and the results are recorded in a questionnaire which is
returned to the trial office. It involves the patient coughing 3 forceful coughs, in
standing position, with a comfortable full bladder and watching for leakage of urine
through the urethra. Although the test is dependent on the patient observation,
however is not subject to patient-clinical relationship bias.
In this sub-study our aim is to assess the diagnostic accuracy of the home cough stress
test compared to the 24 hour pad test (standard) as a tool for assessment of outcomes
following surgical treatment of SUI. We will also assess patient comfort and
satisfaction with each of the tests.
Criteria of successful outcome in both tests:
A) Postoperative cure on 24hr pad test is defined as: pad gain ≤8gm in 24
hours.
B) Postoperative cure on Cough stress test is defined as absence of
demonstrable SUI on 3 consecutive coughs in standing position with
comfortably full bladder.
References:
1. Abrams P, Cardozo L, Fall M, et al. The standardization of terminology of
lower urinary tract function: report from the Standardization Sub-committee of
the International Continence Society. Neurol Urodyn 2002; 21: 167–78.
2. Ryhammer AM, Djurhuus JC, Laurberg S (1999) Pad testing in incontinent
women: a review. Int Urogynecol J 10:111–115
3. Karantanis E, Allen W, Stevermuer TL, Simons AM, O’Sullivan R, More KH
(2005) The repeatability of the 24-hour pad test. Int Urogynecol J 16:63–68.
4. Ghoniem G, Stanford E, Kenton K, Achtari C, Goldberg R, Mascarenhas T et
al (2008) Evaluation and outcome measures in the treatment of female urinary
stress incontinence: International Urogynecological Association (IUGA)
guidelines for research and clinical practice. Int Urogynecol J 19:5–33.
5. Swift SE, Yoon EA (1999) Test–retest reliability of the cough stress test in the
evaluation of urinary incontinence. Obstet Gynecol 94:99–102
6. Swift SE, Ostergard DR. Evaluation of current urodynamic test methods in the
diagnosis of genuine stress incontinence. Obstet Gynecol 1995;86: 85–91.
7. Scotti RJ, Myers DL. A comparison of the cough stress test and single channel
cystometry with multichannel urodynamic evaluation in genuine stress
incontinence. Obstet Gynecol 1993; 81:430–433.
A4
Short Messaging Service (SMS) data collection.
Mobile phones are ubiquitous in today’s society, and the sending and receiving of
text messages is the norm for most users of these devices. The use of SMS
messaging has been explored to deliver intervention, but we propose to explore the
use of this technology to collect short-term pain outcomes on days one to 14 post
intervention and compare this to responses from completed paper pain diaries.