Urinary Incontinence, Stress Clinical Trial
Official title:
Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)
The overarching goal of this randomized trial is to estimate the effect of combined
midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to
MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include
estimating the effect of combined treatment compared to MUS on improving overactive bladder
(OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional
treatment, time to failure and identifying predictors of poor outcomes in this MUI
population.
A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and
vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.
ESTEEM is a multi-center randomized trial of 472 women with MUI who have elected to undergo
surgical treatment for SUI. Participants will be randomized to a peri-operative BPTx
program+MUS versus MUS alone. The purpose is to compare combined MUS+BPTx versus MUS alone
(control) on improving MUI symptoms at 1 year.
Patients will be assigned to one of the two treatment groups. Randomization will be
stratified by clinical site and by UUI "severity," which will be defined by the number of
urgency urinary IEs on diary.
The primary outcome for this study is the mean change from baseline in UDI-total score at 1
year postoperative. The UDI is a validated, disease-specific, patient-reported outcome (PRO)
measure.
Secondary outcomes UUI/OAB outcomes will be measured using the UDI-irritative subscale that
measures symptom burden, impact, and changes related to OAB. It is highly responsive to
treatment-related change and is able to discriminate among levels of change in all bladder
diary variables (urinary urgency, frequency and urge incontinence) and patient ratings of
treatment benefit that will characterize how MUS may affect all OAB symptoms individually and
as a whole. SUI symptom outcomes will be measured using the UDI-stress subscale to compare
SUI outcomes between women randomized to MUS + BPTx versus MUS alone.
Other UUI/OAB outcomes that will be compared between groups include 1) the change in IE
frequency and type, number of urgency episodes, urgency severity with voids, number of
diurnal voids, and number of nocturnal voids using a bladder diary; 2) patient satisfaction
with treatment using the OAB-SAT-q; 3) bother and heal related quality of life using the
OAB-q subscale
For analyzing time to failure, "failure" will be defined as initiation of any additional
treatment for either SUI or UUI/OAB symptoms during the follow-up period. Subjects lost to
follow up will be censored at the time of their last visit.
Quality of life/global impression will be assessed be compared between treatment groups using
the a) Incontinence Impact Questionnaire (IIQ), Pelvic Organ Prolapse/Urinary Incontinence
Sexual Questionnaire (PISQ), c) European Quality of Life-5 Dimensions (EQ-5D), d) Adaptation
Index and e) Patient Global Impression of Improvement (PGI-I) and Patient Global Impression
of Severity (PGI-S).
Safety/additional treatments will be characterized as a) additional re-treatments for SUI or
UUI within 12 months of treatment, and type of re-treatment and b) return to OR for sling
revision due to worsened OAB symptoms.
To evaluate the association between PFM strength and improvements in UI symptoms, we will
objectively assess PFM strength changes using the Peritron Perineometer, and instrument
specifically designed for pelvic floor assessment.
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