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

NCT04029168 | Completed

• 1 other identifier: PN/25/2019
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Pelvic Organ Prolapse; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (37)

• Pelvic Floor Distress Inventory (PFDI-20)

  3 months post treatment

• Pelvic Floor Distress Inventory (PFDI-20)

  12 months post treatment

• Pelvic Floor Distress Inventory (PFDI-20)

  change from the baseline till 3 months post treatment

• Pelvic Floor Distress Inventory (PFDI-20)

  change from the baseline till 12 months post treatment

• Visual Analogue Scale

  3 month post treatment

Study Arms (1)

Pelvic floor surgery

The group will consist of females with pelvic floor disorders (pelvic organ prolapse, stress urinary incontinence) qualified for pelvic floor surgery

Eligibility Criteria

• Age: 30 Years - 90 Years
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with stress urinary incontinence and pelvic organ prolapse

You may qualify if:

• premenopausal and postmenopausal women
• stress urinary incontinence
• pelvic organ prolapse

You may not qualify if:

• \- previous surgical interventions due to stress urinary incontinence or pelvic organ prolapse

Sponsors & Collaborators

• Żelazna Medical Centre, LLC: lead

Study Sites (1)

Centrum Medyczne "ŻELAZNA"

Warsaw, 01-004, Poland

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical; Pregnancy Complications

Study Officials

• Dorota Sys, PhD

  Centre of Postgraduate Medical Education

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 23, 2019
• Study Start: August 1, 2019
• Primary Completion: May 30, 2023
• Study Completion: July 8, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

PL (1)