Urinary Incontinence, Stress
Conditions
Brief summary
A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling
Detailed description
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.
Interventions
DEVICEMini-arc
We will place a single incision sling at the time of surgery for stress urinary incontinence
DEVICEMonarc
We will place a transobturator sling at the time of surgery for stress urinary incontinence
Sponsors
Cecilia Calvo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.
Exclusion criteria
* Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Stress Urinary Incontinence | 1 year | The primary outcome was presence of leakage during cough stress test(CST) on examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire UDI-6 | 1 year | 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. |
| Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence | 1 year | Assess if the patient has any complaint of stress urinary incontinence after surgery in follow up visits. This will be history only, no examination. |
| Number of Participants Who Completed Self- Assessment of Cure | 1 year | 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. |
| Quality of Life Questionnaire IIQ-7 | 1 year | 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. |
| Quality of Life Questionnaire ICIQ | 1 year | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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 | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | Mini-arc | Monarc | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 98 Participants |
| Age, Continuous | 52.9 years | 48.9 years | 50 years |
| Region of Enrollment United States | 49 Participants | 49 Participants | 98 Participants |
| Sex: Female, Male Female | 49 Participants | 49 Participants | 98 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 49 | 5 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Objective Stress Urinary Incontinence
The primary outcome was presence of leakage during cough stress test(CST) on examination
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monarc | Objective Stress Urinary Incontinence | 9 Participants |
| Mini-arc | Objective Stress Urinary Incontinence | 12 Participants |
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monarc | Number of Participants Who Completed Self- Assessment of Cure | 37 Participants |
| Mini-arc | Number of Participants Who Completed Self- Assessment of Cure | 31 Participants |
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monarc | Quality of Life Questionnaire ICIQ | 3.1 scores on a scale | Standard Deviation 3.8 |
| Mini-arc | Quality of Life Questionnaire ICIQ | 3.9 scores on a scale | Standard Deviation 4.3 |
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monarc | Quality of Life Questionnaire IIQ-7 | 8.95 score on a scale | Standard Deviation 17.9 |
| Mini-arc | Quality of Life Questionnaire IIQ-7 | 12.7 score on a scale | Standard Deviation 20.8 |
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monarc | Quality of Life Questionnaire UDI-6 | 15.1 score on a scale | Standard Deviation 16.4 |
| Mini-arc | Quality of Life Questionnaire UDI-6 | 20.3 score on a scale | Standard Deviation 20.4 |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Monarc | Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence | 11 participants |
| Mini-arc | Subjective Patient Reported Recurrent or Persistent Stress Urinary Incontinence | 21 participants |