Clinical trial NCT04029168: Pelvic Floor Muscles and Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Pelvic Organ Prolapse
Pelvic Floor Disorders
Lead sponsor: Żelazna Medical Centre, LLC
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 140
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with stress urinary incontinence and pelvic organ prolapse

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: change from the baseline till 6 months post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: change from the baseline till 6 month post treatment
measure: Marshall-Bonney test
timeFrame: change from the baseline till 6 months post treatment
Secondary outcomes:
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: 3 months post treatment
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: 12 months post treatment
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: change from the baseline till 3 months post treatment
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: change from the baseline till 12 months post treatment
measure: Visual Analogue Scale
timeFrame: 3 month post treatment
measure: Visual Analogue Scale
timeFrame: 6 months post treatment
measure: Visual Analogue Scale
timeFrame: 12 months post treatment
measure: Visual Analogue Scale
timeFrame: change from the baseline till 3 months post treatment
measure: Visual Analogue Scale
timeFrame: change from the baseline till 6 months post treatment
measure: Visual Analogue Scale
timeFrame: change from the baseline till 12 months post treatment
measure: PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
timeFrame: 3 month post treatment
measure: PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
timeFrame: 6 months post treatment
measure: PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
timeFrame: 12 months post treatment
measure: PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
timeFrame: change from the baseline till 3 months post treatment
measure: PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
timeFrame: change from the baseline till 6 months post treatment
measure: PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
timeFrame: change from the baseline till 12 months post treatment
measure: Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
timeFrame: 3 months post treatment
measure: Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
timeFrame: 6 months post treatment
measure: Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
timeFrame: 12 months post treatment
measure: Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
timeFrame: change from the baseline till 3 months post treatment
measure: Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
timeFrame: change from the baseline till 6 months post treatment
measure: Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
timeFrame: change from the baseline till 12 months post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: at 1 month post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: 3 months post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: 12 months post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: change from the baseline till 3 month post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: change from the baseline till 12 month post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: change from the baseline till 1 month post treatment
measure: Marshall-Bonney test
timeFrame: at 1 month post treatment
measure: Marshall-Bonney test
timeFrame: 3 months post treatment
measure: Marshall-Bonney test
timeFrame: 12 months post treatment
measure: Marshall-Bonney test
timeFrame: change from the baseline till 3 months post treatment
measure: Marshall-Bonney test
timeFrame: change from the baseline till 1 month post treatment
measure: Marshall-Bonney test
timeFrame: change from the baseline till 12 months post treatment
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: 6 months post treatment
measure: Pelvic floor organ prolapse quantification (POP-Q)
timeFrame: 6 months post treatment
measure: Marshall-Bonney test
timeFrame: 6 months post treatment
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Centrum Medyczne "ŻELAZNA"
Study officials:
affiliation: Centre of Postgraduate Medical Education
name: Dorota Sys, PhD
role: STUDY_CHAIR
References: