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NCT04029168 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04029168
Other study ID # PN/25/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date July 8, 2023

Study information
Verified date July 2023
Source Zelazna Medical Centre, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date July 8, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers
Gender Female
Age group 30 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Poland Centrum Medyczne "ZELAZNA" Warsaw

Sponsors (1)
Lead Sponsor Collaborator
Zelazna Medical Centre, LLC

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Visual Analogue Scale Distress assessment range 0-10, higher numbers represent better outcomes 3 month post treatment
Secondary Visual Analogue Scale Distress assessment range 0-10, higher numbers represent better outcomes 6 months post treatment
Secondary Visual Analogue Scale Distress assessment range 0-10, higher numbers represent better outcomes 12 months post treatment
Secondary Visual Analogue Scale Distress assessment range 0-10, higher numbers represent better outcomes change from the baseline till 3 months post treatment
Secondary Visual Analogue Scale Distress assessment range 0-10, higher numbers represent better outcomes change from the baseline till 6 months post treatment
Secondary Visual Analogue Scale Distress assessment range 0-10, higher numbers represent better outcomes change from the baseline till 12 months post treatment
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Pelvic floor organ prolapse quantification (POP-Q) Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes at 1 month post treatment
Secondary Pelvic floor organ prolapse quantification (POP-Q) Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes 3 months post treatment
Secondary Pelvic floor organ prolapse quantification (POP-Q) Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes 12 months post treatment
Secondary 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
Secondary 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
Secondary 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
Secondary Marshall-Bonney test Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence at 1 month post treatment
Secondary Marshall-Bonney test Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence 3 months post treatment
Secondary Marshall-Bonney test Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence 12 months post treatment
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Pelvic floor organ prolapse quantification (POP-Q) Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes 6 months post treatment
Secondary Marshall-Bonney test Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence 6 months post treatment
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