Combined Treatment for Mixed Incontinence

NCT01959347 | Completed Phase 3 Results DMC

• 10 other identifiers: PFDN-26P01U10HD041261U10HD069013U10HD054215U10HD041267U10HD054214U10HD069025U10HD069010U10HD041263U01HD069031
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

Keywords

urinary incontinence; midurethral sling; pelvic floor therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline UDI Total Score

  The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  3, 6, and 12 Months

Secondary Outcomes (3)

• Change From Baseline UDI Stress Score

  3, 6, and 12 Months

• Change From Baseline UDI Irritative Score

  3, 6, and 12 Months

• Change From Baseline UDI Obstructive Score

  3, 6, and 12 Months

Other Outcomes (46)

• Change From Baseline Number of Stress Incontinence Episodes

  2 weeks and 2, 6, and 12 Months

• Change From Baseline Number of Urge Incontinence Episodes

  2 weeks and 2, 6, and 12 Months

• Change From Baseline Number of Unknown Incontinence Episodes

  2 weeks and 2, 6, and 12 Months

Study Arms (2)

Miduretheral Sling (Control)

SHAM COMPARATOR

Miduretheral Sling (Control)

Procedure: Miduretheral Sling

MUS+BPTx

EXPERIMENTAL

Miduretheral Sling with behavioral/pelvic floor therapy

Other: Miduretheral Sling with behavioral/pelvic floor therapy

Interventions

Miduretheral Sling PROCEDURE

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).

Also known as: MUS

Miduretheral Sling (Control)

Miduretheral Sling with behavioral/pelvic floor therapy OTHER

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.

Also known as: MUS + BPTx

MUS+BPTx

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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) who do not report vaginal bulge symptoms will be eligible
• Planned concomitant surgery for anterior vaginal wall or apical prolapse \> 0
• a)Women undergoing only rectocele repair are eligible
• Women undergoing hysterectomy for any indication will be excluded
• Active pelvic organ malignancy
• Age \<21 years
• Pregnant or plans for future pregnancy in next 12 months, or within 12 months post-partum
• Post-void residual \>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

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• Women and Infants Hospital of Rhode Island: collaborator
• The Cleveland Clinic: collaborator
• Duke University: collaborator
• University of Alabama at Birmingham: collaborator
• University of New Mexico: collaborator
• University of Pennsylvania: collaborator
• University of Pittsburgh: collaborator
• University of California, San Diego: collaborator
• Kaiser Permanente: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• RTI International: collaborator

Study Sites (10)

University of Alabama at Birmingham, Department of Obstetrics and Gynecology

Birmingham, Alabama, 35249-7333, United States

Location

Kaiser Permanente -- Downey

Downey, California, 90242, United States

Location

University of California at San Diego, UCSD Women's Pelvic Medicine Center

La Jolla, California, 92037-0974, United States

Location

Kaiser Permanente -- San Diego

San Diego, California, 92110, United States

Location

University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology

Albuquerque, New Mexico, 87131-0001, United States

Location

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, 27707, United States

Location

Cleveland Clinic, Department OB/GYN

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee-Womens Hospital, Department of Obstetrics and Gynecology

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

• 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.

  PMID: 34297969 DERIVED

• 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.

  PMID: 34237755 DERIVED

• 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.

  PMID: 32769647 DERIVED

• 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.

  PMID: 31529007 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marie Gantz
• Organization: RTI International

mgantz@rti.org

919-597-5110

Study Officials

• Vivian W. Sung

  Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

• Dennis Wallace

  RTI International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: October 28, 2013
• Primary Completion: August 9, 2017
• Study Completion: September 29, 2017
• Last Updated: May 14, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)