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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence; Pelvic Floor Disorders

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-004
    • Centrum Medyczne "ŻELAZNA"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women with stress urinary incontinence and pelvic organ prolapse

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pelvic floor surgery; 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?

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

Collaborators and Investigators

• Sponsor: Żelazna Medical Centre, LLC
• Investigators: Study Chair: Dorota Sys, PhD, Centre of Postgraduate Medical Education

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): July 8, 2023

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Pregnancy Complications; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis; Urinary Incontinence, Stress; Pelvic Floor Disorders
• Other Study ID Numbers: PN/25/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No