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

Completed

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

• Registration Number: NCT04029168
• Lead Sponsor: Żelazna Medical Centre, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Study Start: 2019-08-01
• Primary Completion: 2023-05-30
• Status Verified: 2023-07
• Study Completion: 2023-07-08
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic floor organ prolapse quantification (POP-Q)	change from the baseline till 6 month post treatment	Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Marshall-Bonney test	change from the baseline till 6 months post treatment	Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Pelvic Floor Distress Inventory (PFDI-20)	change from the baseline till 6 months post treatment	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.

Secondary Outcome Measures

Name	Time	Method
Pelvic floor organ prolapse quantification (POP-Q)	6 months post treatment	Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Pelvic Floor Distress Inventory (PFDI-20)	6 months post treatment	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.
Marshall-Bonney test	6 months post treatment	Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Visual Analogue Scale	change from the baseline till 12 months post treatment	Distress assessment range 0-10, higher numbers represent better outcomes
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)	change from the baseline till 12 months post treatment	Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)	change from the baseline till 12 months post treatment	To measure the impact of urinary incontinence on activities, roles and emotional states

Trial Locations

Locations (1)

Centrum Medyczne "ŻELAZNA"; 🇵🇱 Warsaw, Poland