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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04029168

Enrollment

140

Registered

2019-07-23

Start date

2019-08-01

Completion date

2023-07-08

Last updated

2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders, Pelvic Organ Prolapse, Stress Urinary Incontinence

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Secondary

Measure	Time frame	Description
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
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.
Marshall-Bonney test	at 1 month post treatment	Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Pelvic floor organ prolapse quantification (POP-Q)	at 1 month post treatment	Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Visual Analogue Scale	3 month post treatment	Distress assessment range 0-10, higher numbers represent better outcomes
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

Countries

Poland

Outcome results