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Completed

NCT Number: NCT04029168

Pelvic Floor Muscles and 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.

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Key information

Conditions

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

Age range

30 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Centrum Medyczne "ŻELAZNA"

Warsaw, 01-004, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: 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.

  2. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: change from the baseline till 6 month post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  3. Marshall-Bonney test

    Time frame: change from the baseline till 6 months post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

Secondary outcomes

  1. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: 3 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.

  2. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: 12 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.

  3. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: change from the baseline till 3 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.

  4. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: change from the baseline till 12 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.

  5. Visual Analogue Scale

    Time frame: 3 month post treatment

    Distress assessment range 0-10, higher numbers represent better outcomes

  6. Visual Analogue Scale

    Time frame: 6 months post treatment

    Distress assessment range 0-10, higher numbers represent better outcomes

  7. Visual Analogue Scale

    Time frame: 12 months post treatment

    Distress assessment range 0-10, higher numbers represent better outcomes

  8. Visual Analogue Scale

    Time frame: change from the baseline till 3 months post treatment

    Distress assessment range 0-10, higher numbers represent better outcomes

  9. Visual Analogue Scale

    Time frame: change from the baseline till 6 months post treatment

    Distress assessment range 0-10, higher numbers represent better outcomes

  10. Visual Analogue Scale

    Time frame: change from the baseline till 12 months post treatment

    Distress assessment range 0-10, higher numbers represent better outcomes

  11. PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)

    Time frame: 3 month post treatment

    Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact

  12. PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)

    Time frame: 6 months post treatment

    Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact

  13. PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)

    Time frame: 12 months post treatment

    Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact

  14. PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)

    Time frame: change from the baseline till 3 months post treatment

    Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact

  15. PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)

    Time frame: change from the baseline till 6 months post treatment

    Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact

  16. PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)

    Time frame: 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

  17. Incontinence impact Questionnaire-Short Form (IIQ-7 SF)

    Time frame: 3 months post treatment

    To measure the impact of urinary incontinence on activities, roles and emotional states

  18. Incontinence impact Questionnaire-Short Form (IIQ-7 SF)

    Time frame: 6 months post treatment

    To measure the impact of urinary incontinence on activities, roles and emotional states

  19. Incontinence impact Questionnaire-Short Form (IIQ-7 SF)

    Time frame: 12 months post treatment

    To measure the impact of urinary incontinence on activities, roles and emotional states

  20. Incontinence impact Questionnaire-Short Form (IIQ-7 SF)

    Time frame: change from the baseline till 3 months post treatment

    To measure the impact of urinary incontinence on activities, roles and emotional states

  21. Incontinence impact Questionnaire-Short Form (IIQ-7 SF)

    Time frame: change from the baseline till 6 months post treatment

    To measure the impact of urinary incontinence on activities, roles and emotional states

  22. Incontinence impact Questionnaire-Short Form (IIQ-7 SF)

    Time frame: change from the baseline till 12 months post treatment

    To measure the impact of urinary incontinence on activities, roles and emotional states

  23. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: at 1 month post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  24. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: 3 months post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  25. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: 12 months post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  26. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: change from the baseline till 3 month post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  27. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: change from the baseline till 12 month post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  28. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: change from the baseline till 1 month post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  29. Marshall-Bonney test

    Time frame: at 1 month post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

  30. Marshall-Bonney test

    Time frame: 3 months post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

  31. Marshall-Bonney test

    Time frame: 12 months post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

  32. Marshall-Bonney test

    Time frame: change from the baseline till 3 months post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

  33. Marshall-Bonney test

    Time frame: change from the baseline till 1 month post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

  34. Marshall-Bonney test

    Time frame: change from the baseline till 12 months post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

  35. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: 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.

  36. Pelvic floor organ prolapse quantification (POP-Q)

    Time frame: 6 months post treatment

    Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes

  37. Marshall-Bonney test

    Time frame: 6 months post treatment

    Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence

Sponsors and collaborators

Lead sponsor

Żelazna Medical Centre, LLC

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2019
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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