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A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.
In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.
However, to date the success and complications of these two procedures have not been compared or studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monarc | Active Comparator | Placement of a transobturator monarc sling for stress urinary incontinence |
|
| Mini-arc | Experimental | Placement of a single incision mini-arc sling for stress urinary incontinence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini-arc | Device | We will place a single incision sling at the time of surgery for stress urinary incontinence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Stress Urinary Incontinence | The primary outcome was presence of leakage during cough stress test(CST) on examination | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire UDI-6 | Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G Willy Davila, MD | Cleveland Clinic Florida | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37888839 | Derived | Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Monarc | Placement of a transobturator monarc sling for stress urinary incontinence Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence |
| FG001 | Mini-arc | Placement of a single incision mini-arc sling for stress urinary incontinence Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Monarc | Placement of a transobturator monarc sling for stress urinary incontinence Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence |
| BG001 | Mini-arc |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Objective Stress Urinary Incontinence | The primary outcome was presence of leakage during cough stress test(CST) on examination | Posted | Count of Participants | Participants | 1 year |
|
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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 | Monarc | Placement of a transobturator monarc sling for stress urinary incontinence Monarc: We will place a transobturator sling at the time of surgery for stress urinary incontinence |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sling transectio | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| G W Davila | Cleveland Clinic Florida | 9546595559 | davilag@ccf.org |
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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 |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Monarc | Device | We will place a transobturator sling at the time of surgery for stress urinary incontinence |
|
|
| 1 year |
| Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence | Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination. | 1 year |
| Number of Participants Who Completed Self- Assessment of Cure | Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed. | 1 year |
| Quality of Life Questionnaire IIQ-7 | Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected. | 1 year |
| Quality of Life Questionnaire ICIQ | Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence. | 1 year |
Placement of a single incision mini-arc sling for stress urinary incontinence
Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Quality of Life Questionnaire UDI-6 | Response to validated questionnaire: Urinary Distress Index(UDI-6) Measures symptoms on three subscales: 1. Irritative 2. Stress 3. Obstructive/Discomfort. The mean value of all questions answered is then multiplied by 25 for the actual score (range 0 to 100) Summary score - Add the scores from the 3 scales together to obtain the summary score (range 0 to 300) The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| Secondary | Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence | Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination. | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Number of Participants Who Completed Self- Assessment of Cure | Self-assessment of cure is based on 5 point scale, cured, greatly improved, somewhat improved, not improved, and worsened. This is calculated by the number of patients that were analyzed. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Quality of Life Questionnaire IIQ-7 | Response to validated questionnaire: Incontinence Impact Questionnaire(IIQ-7) The IIQ measures the impact of urinary incontinence on activities roles, and emotional states. A mean score is derived from each domain, then transferred to give weight to each subscale. Subscale scores range from 0-100. The total IIQ score is calculated by adding the four subscales score with a range of 0-400 possible. A score closer to 0 represents activities not affected at all versus closer to 400 represent activities that were greatly affected. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| Secondary | Quality of Life Questionnaire ICIQ | Response to validated questionnaire: International Consultation on Incontinence Questionnaire(ICIQ). The ICIQ is a screening tool for incontinence. The scoring scale is 0-21, minimum 0, maximum 21. a higher score indicates greater impairment from incontinence. | Posted | Mean | Standard Deviation | scores on a scale | 1 year |
|
|
|
| 0 |
| 49 |
| 2 |
| 49 |
| EG001 | Mini-arc | Placement of a single incision mini-arc sling for stress urinary incontinence Mini-arc: We will place a single incision sling at the time of surgery for stress urinary incontinence | 0 | 49 | 5 | 49 |
| mesh exposure | Surgical and medical procedures | Systematic Assessment |
|
| dyspareunia | Surgical and medical procedures |
|
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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 |