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| Name | Class |
|---|---|
| Friends of Prentice | OTHER |
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This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA injections | Active Comparator | 100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery. |
|
| Saline injections | Sham Comparator | 100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA (Botox ®) Injections | Drug | OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms | Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incontinence Episode Frequency | Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject | 3 months after surgery |
| Urinary Incontinence Symptoms and Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Kenton, M.D. | Professor, Departments of Obstetrics and Gynecology, Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine Integrated Pelvic Health Clinic | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33278293 | Result | Komar A, Bretschneider CE, Mueller MG, Lewicky-Gaupp C, Collins S, Geynisman-Tan J, Tavathia M, Kenton K. Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):12-20. doi: 10.1097/AOG.0000000000004198. |
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Note: 100 participants were consented and is the enrollment number, but 12 participants cancelled their surgeries after having signed the consent form. Thus, 88 participants were randomized and are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | OnabotulinumtoxinA Injections | 100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery. OnabotulinumtoxinA (Botox ®) Injections: OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence. |
| FG001 | Saline Injections | 100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery. Saline Injections: Saline will be injected into the bladder so that investigators are masked to subject randomization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group/Saline Injections | The placebo arm received intradetrusor saline injections at the time of their sling. |
| BG001 | Onabotulinum Toxin A | The onabotulinum toxin A group received intradetrusor injections of 100 U onabotulinum toxin A and the placebo group received intradetrusor injections of saline at the time of midurethral sling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms | Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome | Posted | Count of Participants | Participants | 3 months after surgery |
|
3-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Group/Saline Injections | Placebo Group/Saline Injections | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation | Renal and urinary disorders | Systematic Assessment | Re-operation for persistent stress incontinence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Retention within 2 Weeks Surgery | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kimberly Kenton | Northwestern University | 3124723874 | kkenton@nm.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2021 | Feb 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2022 | Dec 22, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2019 | Feb 16, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Saline Injections | Drug | Saline will be injected into the bladder so that investigators are masked to subject randomization. |
|
Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject. The scale is 0-100. and higher scores indicate worse outcomes.
| 3 months after surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Gender (only individuals born with female genitalia were included in the study) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| UDI-6 | Urinary Distress Inventory, Short Form. The scale is (0-100) and higher values indicate a worse outcome. | Median | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Incontinence Episode Frequency | Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject | Incontinence Episode Frequency on 3 day Diary | Posted | Median | Inter-Quartile Range | episodes | 3 months after surgery |
|
|
|
| Secondary | Urinary Incontinence Symptoms and Quality of Life | Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject. The scale is 0-100. and higher scores indicate worse outcomes. | IIQ-7: Incontinence QOL | Posted | Median | Inter-Quartile Range | units on a scale | 3 months after surgery |
|
|
|
| 37 |
| 1 |
| 37 |
| 6 |
| 37 |
| EG001 | Onabotulinum Toxin A Group | 100 U onabotulinum toxin A group | 0 | 41 | 0 | 41 | 22 | 41 |
|
| Urinary Retention between 2 Weeks and 3 Months | Renal and urinary disorders | Systematic Assessment |
|
| Mesh Exposure | Renal and urinary disorders | Systematic Assessment |
|
| UTI | Renal and urinary disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |