Pelvic Floor Muscles and Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Study Overview
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Brief Summary
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The aim of the study is evaluation of the efficiency of pelvic floor muscles in the context of surgical outcomes in the treatment of stress urinary incontinence and pelvic organ prolapse.

Official Title
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Pelvic Floor Muscles Efficiency as an Independent Factor of Therapeutic Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Conditions
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Stress Urinary Incontinence, Pelvic Organ Prolapse, Pelvic Floor Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premenopausal and postmenopausal women stress urinary incontinence pelvic organ prolapse Exclusion Criteria: - previous surgical interventions due to stress urinary incontinence or pelvic organ prolapse

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pelvic floor surgery<br>The group will consist of females with pelvic floor disorders (pelvic organ prolapse, stress urinary incontinence) qualified for pelvic floor surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Distress Inventory (PFDI-20) | Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. | change from the baseline till 6 months post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | change from the baseline till 6 month post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | change from the baseline till 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Distress Inventory (PFDI-20) | Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. | 3 months post treatment | 
| Pelvic Floor Distress Inventory (PFDI-20) | Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. | 12 months post treatment | 
| Pelvic Floor Distress Inventory (PFDI-20) | Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. | change from the baseline till 3 months post treatment | 
| Pelvic Floor Distress Inventory (PFDI-20) | Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. | change from the baseline till 12 months post treatment | 
| Visual Analogue Scale | Distress assessment range 0-10, higher numbers represent better outcomes | 3 month post treatment | 
| Visual Analogue Scale | Distress assessment range 0-10, higher numbers represent better outcomes | 6 months post treatment | 
| Visual Analogue Scale | Distress assessment range 0-10, higher numbers represent better outcomes | 12 months post treatment | 
| Visual Analogue Scale | Distress assessment range 0-10, higher numbers represent better outcomes | change from the baseline till 3 months post treatment | 
| Visual Analogue Scale | Distress assessment range 0-10, higher numbers represent better outcomes | change from the baseline till 6 months post treatment | 
| Visual Analogue Scale | Distress assessment range 0-10, higher numbers represent better outcomes | change from the baseline till 12 months post treatment | 
| PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7) | Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact | 3 month post treatment | 
| PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7) | Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact | 6 months post treatment | 
| PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7) | Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact | 12 months post treatment | 
| PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7) | Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact | change from the baseline till 3 months post treatment | 
| PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7) | Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact | change from the baseline till 6 months post treatment | 
| PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7) | Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact | change from the baseline till 12 months post treatment | 
| Incontinence impact Questionnaire-Short Form (IIQ-7 SF) | To measure the impact of urinary incontinence on activities, roles and emotional states | 3 months post treatment | 
| Incontinence impact Questionnaire-Short Form (IIQ-7 SF) | To measure the impact of urinary incontinence on activities, roles and emotional states | 6 months post treatment | 
| Incontinence impact Questionnaire-Short Form (IIQ-7 SF) | To measure the impact of urinary incontinence on activities, roles and emotional states | 12 months post treatment | 
| Incontinence impact Questionnaire-Short Form (IIQ-7 SF) | To measure the impact of urinary incontinence on activities, roles and emotional states | change from the baseline till 3 months post treatment | 
| Incontinence impact Questionnaire-Short Form (IIQ-7 SF) | To measure the impact of urinary incontinence on activities, roles and emotional states | change from the baseline till 6 months post treatment | 
| Incontinence impact Questionnaire-Short Form (IIQ-7 SF) | To measure the impact of urinary incontinence on activities, roles and emotional states | change from the baseline till 12 months post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | at 1 month post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | 3 months post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | 12 months post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | change from the baseline till 3 month post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | change from the baseline till 12 month post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | change from the baseline till 1 month post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | at 1 month post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | 3 months post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | 12 months post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | change from the baseline till 3 months post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | change from the baseline till 1 month post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | change from the baseline till 12 months post treatment | 
| Pelvic Floor Distress Inventory (PFDI-20) | Symptom inventory and a measure of the degree of bother and distress. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. | 6 months post treatment | 
| Pelvic floor organ prolapse quantification (POP-Q) | Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes | 6 months post treatment | 
| Marshall-Bonney test | Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence | 6 months post treatment |