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

• Sponsor: Żelazna Medical Centre, LLC (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04029168
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence; Pelvic Organ Prolapse; Pelvic Floor Disorders

Study Design

• Study Type: Observational
• Actual Enrollment: 140 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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

Secondary Outcome Measures

1. Pelvic Floor Distress Inventory (PFDI-20) [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) [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) [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) [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 [3 month post treatment]

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

6. Visual Analogue Scale [6 months post treatment]

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

7. Visual Analogue Scale [12 months post treatment]

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

8. Visual Analogue Scale [change from the baseline till 3 months post treatment]

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

9. Visual Analogue Scale [change from the baseline till 6 months post treatment]

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

10. Visual Analogue Scale [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [3 months post treatment]

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

25. Pelvic floor organ prolapse quantification (POP-Q) [12 months post treatment]

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

26. Pelvic floor organ prolapse quantification (POP-Q) [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) [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) [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 [at 1 month post treatment]

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

30. Marshall-Bonney test [3 months post treatment]

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

31. Marshall-Bonney test [12 months post treatment]

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

32. Marshall-Bonney test [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 [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 [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) [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) [6 months post treatment]

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

37. Marshall-Bonney test [6 months post treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 90 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centrum Medyczne "ŻELAZNA"	Warsaw		Poland	01-004

Sponsors and Collaborators

• Żelazna Medical Centre, LLC

Investigators

• Study Chair: Dorota Sys, PhD, Centre of Postgraduate Medical Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Żelazna Medical Centre, LLC
• ClinicalTrials.gov Identifier: NCT04029168
• Other Study ID Numbers: PN/25/2019
• First Posted: Jul 23, 2019
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Pelvic Floor Disorders; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Jun 7, 2022