Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sling vs Botox for Mixed Incontinence (MUSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171531
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Women and Infants Hospital of Rhode Island
Duke University
University of Pennsylvania
University of Pittsburgh
University of California, San Diego
Kaiser Permanente
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
RTI International
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network

Brief Summary:
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Urinary Incontinence, Urge Drug: Botox® injection Device: Mid-urethral sling Phase 3

Detailed Description:

Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial.

The purpose of MUSA is to:

  • compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI
  • characterize patient characteristics associated with treatment response

The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.

Secondary objectives include identifying predictors of treatment failure and cost-effectiveness of treatments in this MUI population.

A supplemental study will characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: At 6 months, the effect of treatment with Botox A or mid-urethral sling will be evaluated within a classic RCT model. The analysis will determine the effect of treatment on the primary outcome, change in Urogenital Distress Inventory (UDI) score at 6 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Botox A® injection
A dose of 100 units of Botulinum toxin A will be injected into the bladder. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.
Drug: Botox® injection
Botulinum toxin A will be prepared by dissolving 100 units of botulinum toxin A into 10 ml of injectable saline. Indigo carmine or methylene blue 0.1 ml will be added to each syringe of botulinum toxin A. The treating physician will inject a total of 10 ml of the Botox A® into approximately 15 to 20 different detrusor muscle sites under direct visualization.

Active Comparator: Mid-urethral sling
Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.
Device: Mid-urethral sling
Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. "Mini-sling" and "single-incision" sling will not be allowed due to potential risk for higher failure rate.




Primary Outcome Measures :
  1. Change in Urogenital Distress Inventory (UDI) Total Score [ Time Frame: Baseline until 6 months ]
    The Urogenital Distress Inventory Total Score is a standardized a measure of overactive bladder symptoms and health-related quality of life. The score ranges from 0-300 with higher scores indicating a worse outcome. The outcome is calculated as the difference in score at 6 months and the score at baseline.


Secondary Outcome Measures :
  1. Change in Urogenital Distress Inventory (UDI) Stress Subscore [ Time Frame: Baseline until 6 months ]
    The Urogenital Distress Inventory Stress Score is a standardized a measure of stress-related overactive bladder symptoms and quality of life. The score ranges from 0-100 with higher scores indicating a worse outcome.Higher scores mean worse outcome. The outcome is calculated as the difference in the stress subscore at 6 months and the score at baseline.

  2. Change in Urogenital Distress Inventory (UDI) Irritative Sub-Score [ Time Frame: Baseline until 6 months ]
    The Urogenital Distress Inventory Irritative Score is a standardized a measure of irritation-related overactive bladder symptoms and quality of life. The score ranges from 0-100 with higher scores indicating a worse outcome. The outcome is calculated as the difference in the irritative subscore at 6 months and the score at baseline.

  3. Change in Urogenital Distress Inventory (UDI) Total Score [ Time Frame: Baseline until 3 months ]
    The Urogenital Distress Inventory Irritative Score is a standardized a measure of irritation-related overactive bladder symptoms and quality of life. The score ranges from 0-100 with higher scores indicating a worse outcome. The outcome is calculated as the difference in the irritative subscore at 3 months and the score at baseline.


Other Outcome Measures:
  1. Change from baseline Total Number of Incontinence Episodes [ Time Frame: Baseline until 6 months ]
    Based on data collected from participant-completed diaries at baseline and 6 months, the outcome variable is computed as the difference in total number of incontinence episodes at 6 months and the total number of incontinence episodes at baseline. Higher counts mean worse outcome.

  2. Change in Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SATq) Satisfaction Score [ Time Frame: 3 months until 6 months ]
    The Overactive Bladder Satisfaction with Treatment Questionnaire Satisfaction Score is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The score ranges from 0-100 with higher scores indicating a better outcome. The outcome is calculated as a difference between 3 and 6 months.

  3. Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SATq) Side Effect Score [ Time Frame: 3 months until 6 months ]
    The Overactive Bladder Satisfaction with Treatment Questionnaire Side Effect Score is a standardized a measure of the impact of side effects from treatment for overactive bladder symptoms. The score ranges from 0-100 with higher scores indicating a better outcome. The outcome is calculated as a difference between 3 and 6 months.

  4. Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SATq) Endorsement Score [ Time Frame: 3 months until 6 months ]
    The Overactive Bladder Satisfaction with Treatment Questionnaire Endorsement Score is a standardized a measure of endorsement of treatment for overactive bladder symptoms. The score ranges from 0-100 with higher scores indicating a better outcome. The outcome is calculated as a difference between 3 and 6 months.

  5. Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SATq) Convenience Score [ Time Frame: 3 months until 6 months ]
    The Overactive Bladder Satisfaction with Treatment Questionnaire Convenience Score is a standardized a measure of convenience of treatment for overactive bladder symptoms. he score ranges from 0-100 with higher scores indicating a better outcome. The outcome is calculated as a difference between 3 and 6 months.

  6. Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SATq) Preference Score [ Time Frame: 3 months until 6 months. ]
    The Overactive Bladder Satisfaction with Treatment Questionnaire Preference Score is a standardized a measure preference for treatment for overactive bladder symptoms. It is calculated as the percent of respondents who respond "Slight" or "Definite" preference for a new treatment among those respondents who have had previous treatment for overactive bladder. The score ranges from 0-100 with higher scores indicating a better outcome. The outcome is calculated as a difference between 3 and 6 months.

  7. Overactive Bladder Questionnaire-Long Form (OABq-LF) Symptom Severity Score [ Time Frame: Baseline until 6 months ]
    The Overactive Bladder Questionnaire-Long Form Symptom Severity Score is a standardized a measure of the severity of overactive bladder symptoms and quality of life. The score ranges from 0-100 with higher scores indicating a worse outcome. The outcome is calculated as the change from baseline in scores at 3 months and 6 months.

  8. Patient Global Impression of Improvement (PGI-I) [ Time Frame: 3 months until 6 months ]
    The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better). The outcome is calculated as the difference between 3 months and 6 months.

  9. The Patient Global Impression of Severity (PGI-S) [ Time Frame: Baseline until 6 months ]
    The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2. The outcome is calculated as the difference between baseline and 6 months.

  10. Incontinence Impact Questionnaire-Long Form (IIq-LF) Total Score [ Time Frame: 3 months until 6 months ]
    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The score ranges from 0-400 with higher scores indicating a worse outcome. The outcome is calculated as the difference in score at 3 months and 6 months.

  11. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA Revised (PISQ-IR) Sexually Active Average Score [ Time Frame: 3 months and 6 months ]
    The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA Revised Sexually Active Average Score Form is a standardized a measure of sexual function in women with pelvic organ prolapse or urinary incontinence. The score ranges from 1-5 with higher scores indicating better sexual functioning. The outcome is calculated as the difference in score at 3 months and 6 months.

  12. European Quality of Life-5 Dimensions (EQ-5D) Index Score [ Time Frame: 3 months and 6 months ]
    EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The score ranges from 0-1 with higer scores indicating better outcome. The outcome is calculated as the difference in score at 3 months and 6 months.

  13. European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale Score [ Time Frame: 3 months and 6 months ]
    EQ-5D is a standardized instrument developed by the EuroQol Group as a patient-reported measure of health-related quality of life. The score ranges from 0-100 with higher scores meaning better outcome. The outcome is calculated as the difference in score at 3 months and 6 months.

  14. Short-Form Health Survey (SF-36) - Scores [ Time Frame: 3 months and 6 months ]
    The SF-36 is a multi-purpose, short-form health survey with 36 questions providing a score for physical and mental health summary measures. The scores range from 0-100 with higher scores indicating better outcomes. The outcome is calculated as the difference in score at 3 months and 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Reporting at least "moderate bother" from UUI item on UDI

    * "Do you experience urine leakage associated with a feeling of urgency?"

  2. Reporting at least "moderate bother" from SUI item on UDI

    * "Do you experience urine leakage related to physical activity, coughing, or sneezing?"

  3. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
  4. Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
  5. Urinary symptoms >3 months
  6. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.
  7. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is

    1. intolerant of oral overactive bladder medications, or
    2. oral overactive bladder medications are contraindicated as determined by the treating provider.
  8. Urodynamics within past 18 months
  9. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.

Exclusion Criteria:

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

    * 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

    * Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment 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 6 months, or within 12 months post-partum
  7. Post-void residual >150 cc on 2 occasions within the past 6 months, 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 urinary incontinence
  11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth
  12. Women on overactive bladder medication/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 6 month follow-up
  16. Diagnosis of and/or history of bladder pain or chronic pelvic pain
  17. Women who had intravesical Botox injection within the past 12 months
  18. Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171531


Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham, Department of Obstetrics and Gynecology Recruiting
Birmingham, Alabama, United States, 35249
Contact: Holly Richter, PhD, MD    205-934-1704    hrichter@uabmc.edu   
Principal Investigator: Holly E Richter, PhD, MD         
United States, California
University of California at San Diego Recruiting
La Jolla, California, United States, 92037-0974
Contact: Emily Lukacz, MD    858-657-8435    elukacz@health.ucsd.edu   
Principal Investigator: Emily Lukacz, MD         
Kaiser Permanente Recruiting
San Diego, California, United States, 92110
Contact: Shawn Menefee, MD    619-221-6200    Shawn.A.Menefee@kp.org   
Principal Investigator: Shawn Menefee         
United States, North Carolina
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery Recruiting
Durham, North Carolina, United States, 27707
Contact: Anthony G Visco, MD    919-401-1006    anthony.visco@duke.edu   
Principal Investigator: Anthony G Visco, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Heidi Harvie, MD    215-662-4147    HHarvie@uphs.upenn.edu   
Principal Investigator: Heidi Harvie, MD         
Magee-Women's Hospital, Department of Obstetrics and Gynecology Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Halina M Zyczynski, MD    412-641-1440    zyczhm@mwri.magee.edu   
Principal Investigator: Halina M Zyczynski, MD         
United States, Rhode Island
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery Recruiting
Providence, Rhode Island, United States, 02903
Contact: Vivian Sung, MD    401-453-7560    vsung@wihri.org   
Principal Investigator: Vivian Sung, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David Rahn, MD    214-648-6430    david.rahn@utsouthwestern.edu   
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Women and Infants Hospital of Rhode Island
Duke University
University of Pennsylvania
University of Pittsburgh
University of California, San Diego
Kaiser Permanente
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
RTI International
Investigators
Layout table for investigator information
Principal Investigator: Heidi S Harvey, MD University of Pennsylvania
Principal Investigator: Marie Gantz, PhD RTI International
Layout table for additonal information
Responsible Party: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT04171531    
Other Study ID Numbers: PFDN-31P01
U24HD069031-06 ( U.S. NIH Grant/Contract )
UG1HD069013-06 ( U.S. NIH Grant/Contract )
UG1HD041267-18 ( U.S. NIH Grant/Contract )
UG1HD069010-07 ( U.S. NIH Grant/Contract )
UG1HD069006-07 ( U.S. NIH Grant/Contract )
UG1HD041261-17 ( U.S. NIH Grant/Contract )
UG1HD054214-12 ( U.S. NIH Grant/Contract )
UG1HD054241-12 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NICHD Pelvic Floor Disorders Network:
urinary incontinence
midurethral sling
Botulinum toxin A (Botox A ®)
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders