Trials Flashcards
Sister Trial
What was the study design?
Stress Incontinence surgical treatment efficacy trial
fascial sling vs burch
CARE trial
What was the study design?
What was the study population?
What was the aim?
RCT
women undergoing open SCP for POP who did not have symptoms of SUI
women were randomized to
SCP with burch or no Burch
your POP patient wants SCP. She denies SUI sx. how do you counsel her regarding risk of UI after surgery?
What is the risk of OAB after SCP?
correction of SUI can unmask SUI.
this can be evaluated for with a reduction CST.
up to 38% of women with a negative reductions CST can still have SUI post SCP
up to 35% of women can have urge sx or treatment after SCP.
how would you counsel your POP patient regarding the failure rate of SCP vs USLS vs SSLF vs CCLM vs manchester?
Retreatment
4.8 % over 15 years after SCP
9.7% after USLS
18% after SSLF
1.4 % CCLM
7-9% Manchester (1-5 years)
failure can be defines in multiple ways:
anatomic, symptomatic, re-treatment rate
anatomic rate failure at 7 year 28%
symptomatic: 28% of the those with anatomic failure are symptomatic
CARE trial
your POP patient wants vaginal prolapse repair. She denies SUI sx. how do you counsel her regarding risk of UI after surgery?
Why don’t you place a ppx sling in all vaginal prolapse repair patients?
Correction of POP can unmask SUI.
this can be evaluated for with a reduction CST.
among women who have a positive reduction CST and do not undergo a sling, 72% will have SUI at 3 months, this decreases to 30% in those who have a sling.
At 12 months, 27% SUI in sling group vs 43% in sham group.
~6 MUS would need to be placed to prevent one case of SUI at 12 months
OPUS trial - A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair
Describe your basic office evaluation for a healthy patient with stress predominant SUI.
H&P
-History to confirm stress predominant symptoms
-UA
-PVR
-urethral mobility
-no prolapse or prolapse that does not extend 1cm or more distal to the hymen
how does the basic office evaluation for SUI in a healthy patient without other symptoms, compare to UDS.
VALUE trials demonstrated that the office evaluation is non-inferior to UDS
POP wants uterine preservation
how do you counsel her?
First assess candidacy for uterine preservation:
Pap hx
AUB
ovarian pathology
hereditary syndromes
I explain that the uterus itself is not the cause for POP. comparison of uterine sparing POP surgery did not demonstrate worse POP outcomes as compared ot hysterectomy. This finding was consistent with both native tissue and mesh augmented repairs. Additionally, uterine sparing procedures demonstrated less blood loss, less pain, less surgical time and operating costs.
SGS systematic review Merriwether
What are some unknown outcomes regarding uterine sparing POP surgery?
data that goes beyond 3 years after surgery
risk of uterine path after uterine preservation
role for uterine preservation in obliterative procedures
SGS systematic review Merriwether
How do you decide between USLS and SSLF when offering native tissue repair with uterine preservation?
First i begin with assess her candidacy for uterine sparing POP surgery.
Next, I assess for individual factors like sciatica, concern for obliterated posterior cul-de-sac.
Comparison of USLS and SSLF demonstrated no difference in surgical success or serious adverse outcomes at 2 years (64% to 63%)
At 5 years, anatomic failure rate for USLS 61.% vs 70% for SSLF
OPTIMAL trial
Do you recommend perioperative PFPT to your patients undergoing surgery for POP or UI?
Data does not demonstrate improved urinary symptoms at 6 months, POP symptoms at 2 years , or anatomic success at 2 years
OPTIMAL trial
What is the 5 year failure rate of USLS and SSLF?
61% USLS
70% SSLF
but there was sustained improvement in the POP-DI scores
how was surgical failure defined in the OPTIMAL trail?
(1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure),
(2) bothersome bulge symptoms.
Discuss the data comparing TOT to TVT.
- Objective and subjective success rate are similar, as were UUI and satisfaction
Objective 80% TVT vs 77% TOT
Subjective 62% TVT vs 55% TOT
- TVT -more voiding dysfunction (2.7% vs 0%), more OR time, more EBL, more bladder perf
- TOT-worse nerve pain (9.4% vs 4%), more vaginal perf
TOMUS- compared TOT to TVT in women with SUI predominant UI
At what valsalva LPP and MUCP does the rate of sling failure increase and by how much?
valsava LPP <86 cm H2O
MUCP <45 cm H2O
2 fold increase
doesn’t matter which sling you use
TOMUS- compared TOT to TVT in women with SUI predominant UI
Discuss data comparing Burch to Fascial sling.
RCT comparing fascial sling and burch in women with stress predominant UI, +CST.
at 24 months- fascial sling had higher objective and subjective success in UI overall (47% to 38%); and in SUI (66% vs 49%)
fascial sling also had higher voiding dysfunction (14% vs 2%), and urinary retention (48% vs 32%)
SISTer Trial
Patient with SUI wants to know if she should use pessary, PFPT, or both for management.
How do you counsel her?
at 3 months, combo is better than pessary alone and the same at PFPT only. ovarall satisfaction was 60-70%
at 12 months, all outcomes were equal with 50% satisfaction.
ATLAS trial
discuss Botox vs anti-cholinergics
double blinded -double placebo RCT in women who had at least 5 UUI episodes in 3 days
6 month outcome: same reduction in UUI episodes med 3.3 vs botox 3.4
At 6 months, botox has complete resolution in UUI (27% vs 13%)
QOL was the same for both
ABC trial
Which meds were studies in the ABC trial?
solifenacin 5mg, 10mg and trospium
What is the risk of CIC after botox?
5%
ABC trial
What is the risk of UTI after botox?
33%
ABC trial
Your OAB patient wants to know if it is better to see PFPT or do it on her own.
What do you tell her?
at 8 weeks, no objective difference in number of UUI episodes when doing home exercises compared to PFPT with or without biofeedback
However, patient satisfaction was higher with PFPT than home exercises (75-86% vs 56%)
How much weight loss is shown to reduce SUI in obese/overweight women?
loss of 8% body weight can result in up to a 50% improvement in SUI episodes after 6 months
PRIDE trial
how do you counsel on posterior compartment graft for prolapse?
worse outcomes than midline plication at 1 year with significant morbidity
What is the success rate of SNM?
dry vs improved?
62% overall
26% dry
36% improved more than 50%
why place a MUS sling instead of fascial sling?
similar efficacy with lower mobidity, less voiding dysfunction
Your MUI patient wants a sling and wants to know if she needs to do PFPT in addition.
sling alone is just as good as PFPT with sling for women with MUI
ESTEEM trial- PFPT with surgery for MUI vs surgery alone
What is the recurrence rate after USLS?
8-34% - mostly anterior
What is the rate in improvement on OAB symptoms after sling for MUI?
Up to 80%
ESTEEM trial
Describe the efficacy of single incision sling vs TOT
single incision noninferior to MUS
patient with MUI
do you offer botox vs sling first
both can be helpful with either.
MUSA trial
What is the rate of worsening OAB with sling?
10%
failure rate of botox
20%
