Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
480 participants
INTERVENTIONAL
2013-10-28
2017-09-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Miduretheral Sling (Control)
Miduretheral Sling (Control)
Miduretheral Sling
MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).
MUS+BPTx
Miduretheral Sling with behavioral/pelvic floor therapy
Miduretheral Sling with behavioral/pelvic floor therapy
MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.
Interventions
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Miduretheral Sling
MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).
Miduretheral Sling with behavioral/pelvic floor therapy
MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. \> 1 Stress IE/3 day diary
2. \> 1 Urge IE/3 day diary
2. 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?"
3. Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience urine leakage related to coughing, sneezing, or laughing"
4. Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months
5. Desires surgical treatment for SUI symptoms
6. Urinary symptoms \>3 months
7. Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study protocol
8. Urodynamics within past 18 months
Exclusion Criteria
a)Women with anterior or apical prolapse above the hymen (\<0) who do not report vaginal bulge symptoms will be eligible
2. Planned concomitant surgery for anterior vaginal wall or apical prolapse \> 0
a)Women undergoing only rectocele repair are eligible
3. Women undergoing hysterectomy for any indication will be excluded
4. Active pelvic organ malignancy
5. Age \<21 years
6. Pregnant or plans for future pregnancy in next 12 months, or within 12 months post-partum
7. Post-void residual \>150 cc on 2 occasions, or current catheter use
8. Participation in other trial that may influence results of this study
9. Unevaluated hematuria
10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence
11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons
12. Women on anti-muscarinic therapy will be eligible after 3 week wash-out period
13. Non-ambulatory
14. History of serious adverse reaction to synthetic mesh
15. Not able to complete study assessments per clinician judgment, or not available for 12 month follow-up
16. Women who only report "other IE" on bladder diary, and do not report at minimum 1 stress and 1 urge IE/3 days
17. Diagnosis of and/or history of bladder pain or chronic pelvic pain
18. Women who had intravesical Botox injection within the past 12 months
21 Years
FEMALE
No
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
The Cleveland Clinic
OTHER
Duke University
OTHER
University of Alabama at Birmingham
OTHER
University of New Mexico
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
University of California, San Diego
OTHER
Kaiser Permanente
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
RTI International
OTHER
NICHD Pelvic Floor Disorders Network
NETWORK
Responsible Party
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Principal Investigators
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Vivian W. Sung
Role: PRINCIPAL_INVESTIGATOR
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Dennis Wallace
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
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University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, United States
Kaiser Permanente -- Downey
Downey, California, United States
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, United States
Kaiser Permanente -- San Diego
San Diego, California, United States
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Albuquerque, New Mexico, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
Cleveland Clinic, Department OB/GYN
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, United States
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, United States
Countries
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References
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Richter HE, Carnes MU, Komesu YM, Lukacz ES, Arya L, Bradley M, Rogers RG, Sung VW, Siddiqui NY, Carper B, Mazloomdoost D, Dinwiddie D, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence. Am J Obstet Gynecol. 2022 Jan;226(1):93.e1-93.e15. doi: 10.1016/j.ajog.2021.07.008. Epub 2021 Jul 21.
Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2021 Aug 1;138(2):199-207. doi: 10.1097/AOG.0000000000004444.
Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network*. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2020 Sep;136(3):482-491. doi: 10.1097/AOG.0000000000003989.
Sung VW, Borello-France D, Newman DK, Richter HE, Lukacz ES, Moalli P, Weidner AC, Smith AL, Dunivan G, Ridgeway B, Nguyen JN, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1066-1076. doi: 10.1001/jama.2019.12467.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PFDN-26P01
Identifier Type: -
Identifier Source: org_study_id
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