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Phase 3 N=480 Randomized Single-blind Treatment

Combined Treatment for Mixed Incontinence

Urinary Incontinence, Stress · Urinary Incontinence, Urge

Bottom Line

View on ClinicalTrials.gov: NCT01959347 ↗
Enrolled (actual)
480
Serious AEs
10.2%
Results posted
May 2020
Primary outcome: Primary: Change From Baseline UDI Total Score — -138.8; -142.7; -137; -147.4 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Miduretheral Sling (Procedure); Miduretheral Sling with behavioral/pelvic floor therapy (Other)
Age
Adult, Older Adult · 21+ yrs
Sex
Female
Sponsor
NICHD Pelvic Floor Disorders Network
Primary completion
Aug 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline UDI Total Score		 -138.8; -142.7; -137; -147.4; -137.9; -147.7 —
SECONDARY
Change From Baseline UDI Stress Score		 -70.6; -72.5; -69.5; -72.8; -69.3; -73.8 —
SECONDARY
Change From Baseline UDI Irritative Score		 -49.7; -50.1; -49.5; -53.5; -50; -53.5 —
SECONDARY
Change From Baseline UDI Obstructive Score		 -18.5; -20.2; -18; -21.1; -18.5; -20.3 —

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days
  • > 1 Stress IE/3 day diary
  • > 1 Urge IE/3 day diary
  • Reporting at least "moderate bother" from UUI item on the UDI "Do you usually experience urine leakage associated with a feeling of urgency, that is a strong sensation of needing to go to the bathroom?"
  • Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience urine leakage related to coughing, sneezing, or laughing"
  • Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months
  • Desires surgical treatment for SUI symptoms
  • Urinary symptoms >3 months
  • Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study protocol
  • Urodynamics within past 18 months

Exclusion Criteria

  • Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic

a)Women with anterior or apical prolapse above the hymen ( 0

a)Women undergoing only rectocele repair are eligible

  • Women undergoing hysterectomy for any indication will be excluded
  • Active pelvic organ malignancy
  • Age 150 cc on 2 occasions, or current catheter use
  • Participation in other trial that may influence results of this study
  • Unevaluated hematuria
  • Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence
  • Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons
  • Women on anti-muscarinic therapy will be eligible after 3 week wash-out period
  • Non-ambulatory
  • History of serious adverse reaction to synthetic mesh
  • Not able to complete study assessments per clinician judgment, or not available for 12 month follow-up
  • Women who only report "other IE" on bladder diary, and do not report at minimum 1 stress and 1 urge IE/3 days
  • Diagnosis of and/or history of bladder pain or chronic pelvic pain
  • Women who had intravesical Botox injection within the past 12 months
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01959347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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