Stress Urinary IncontinenceNCT04029168
Pelvic Floor Muscles and Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
An observational study of Stress Urinary Incontinence and Pelvic Organ Prolapse, run by Żelazna Medical Centre, LLC at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Organ Prolapse, Pelvic Floor Disorders
- How many people
- 140 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2019to 8 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- Women only
- Adult, Older adult
Study population: Women with stress urinary incontinence and pelvic organ prolapse
Who may be able to join
- premenopausal and postmenopausal women
- stress urinary incontinence
- pelvic organ prolapse
Who cannot join
- previous surgical interventions due to stress urinary incontinence or pelvic organ prolapse
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Organ Prolapse, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor surgery | The group will consist of females with pelvic floor disorders (pelvic organ prolapse, stress urinary incontinence) qualified for pelvic floor surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: change from the baseline till 6 months post treatment
Secondary outcomes (37)
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.
Measured: 3 months post treatment
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.
Measured: 12 months post treatment
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.
Measured: change from the baseline till 3 months post treatment
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.
Measured: change from the baseline till 12 months post treatment
Visual Analogue Scale
Distress assessment range 0-10, higher numbers represent better outcomes
Measured: 3 month post treatment
Visual Analogue Scale
Distress assessment range 0-10, higher numbers represent better outcomes
Measured: 6 months post treatment
Visual Analogue Scale
Distress assessment range 0-10, higher numbers represent better outcomes
Measured: 12 months post treatment
Visual Analogue Scale
Distress assessment range 0-10, higher numbers represent better outcomes
Measured: change from the baseline till 3 months post treatment
Visual Analogue Scale
Distress assessment range 0-10, higher numbers represent better outcomes
Measured: change from the baseline till 6 months post treatment
Visual Analogue Scale
Distress assessment range 0-10, higher numbers represent better outcomes
Measured: change from the baseline till 12 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact
Measured: 3 month post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact
Measured: 6 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact
Measured: 12 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact
Measured: change from the baseline till 3 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact
Measured: change from the baseline till 6 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Assessment of life impact in women with pelvic floor disorders, range 0-300, higher numbers indicate greater impact
Measured: change from the baseline till 12 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
To measure the impact of urinary incontinence on activities, roles and emotional states
Measured: 3 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
To measure the impact of urinary incontinence on activities, roles and emotional states
Measured: 6 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
To measure the impact of urinary incontinence on activities, roles and emotional states
Measured: 12 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
To measure the impact of urinary incontinence on activities, roles and emotional states
Measured: change from the baseline till 3 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
To measure the impact of urinary incontinence on activities, roles and emotional states
Measured: change from the baseline till 6 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
To measure the impact of urinary incontinence on activities, roles and emotional states
Measured: change from the baseline till 12 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Measured: at 1 month post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Measured: 3 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Measured: 12 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Measured: change from the baseline till 3 month post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Measured: change from the baseline till 12 month post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Measured: change from the baseline till 1 month post treatment
Marshall-Bonney test
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Measured: at 1 month post treatment
Marshall-Bonney test
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Measured: 3 months post treatment
Marshall-Bonney test
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Measured: 12 months post treatment
Marshall-Bonney test
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Measured: change from the baseline till 3 months post treatment
Marshall-Bonney test
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Measured: change from the baseline till 1 month post treatment
Marshall-Bonney test
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Measured: change from the baseline till 12 months post treatment
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.
Measured: 6 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Quantification of pelvic organ prolapse, range 0-4, higher indicate worse outcomes
Measured: 6 months post treatment
Marshall-Bonney test
Assessment of stress urinary incontinence, test can be negative or positive, positive test indicates incontinence
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Aug 2019
- Primary completion30 May 2023
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorota Sys, PhD, Study chair, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029168
- Sponsor's protocol ID
- PN/25/2019
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2019
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Szymanski JK, Starzec-Proserpio M, Bartosinska-Raczkiewicz D, Krawczyk A, Kukulski P, Jakiel G. Impact of preoperative pelvic floor muscle function on the success of surgical treatment of pelvic organ prolapse. Int Urogynecol J. 2024 Jan;35(1):85-93. doi: 10.1007/s00192-023-05653-8. Epub 2023 Oct 11.
PubMed 37819368
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04029168
- Acronym / sponsor ID
- PN/25/2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor surgery | – | –The group will consist of females with pelvic floor disorders (pelvic organ prolapse, stress urinary incontinence) qualified for pelvic floor surgery |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with stress urinary incontinence and pelvic organ prolapse
Key inclusion criteria (3 listed)
- premenopausal and postmenopausal women
- stress urinary incontinence
- pelvic organ prolapse
Key exclusion criteria (1 listed)
- previous surgical interventions due to stress urinary incontinence or pelvic organ prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
37 secondary outcomes
Pelvic Floor Distress Inventory (PFDI-20)
Time frame: 3 months post treatment
Pelvic Floor Distress Inventory (PFDI-20)
Time frame: 12 months post treatment
Pelvic Floor Distress Inventory (PFDI-20)
Time frame: change from the baseline till 3 months post treatment
Pelvic Floor Distress Inventory (PFDI-20)
Time frame: change from the baseline till 12 months post treatment
Visual Analogue Scale
Time frame: 3 month post treatment
Visual Analogue Scale
Time frame: 6 months post treatment
Visual Analogue Scale
Time frame: 12 months post treatment
Visual Analogue Scale
Time frame: change from the baseline till 3 months post treatment
Visual Analogue Scale
Time frame: change from the baseline till 6 months post treatment
Visual Analogue Scale
Time frame: change from the baseline till 12 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Time frame: 3 month post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Time frame: 6 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Time frame: 12 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Time frame: change from the baseline till 3 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Time frame: change from the baseline till 6 months post treatment
PELVIC FLOOR IMPACT QUESTIONNAIRE SHORT FORM (PFIQ-7)
Time frame: change from the baseline till 12 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
Time frame: 3 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
Time frame: 6 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
Time frame: 12 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
Time frame: change from the baseline till 3 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
Time frame: change from the baseline till 6 months post treatment
Incontinence impact Questionnaire-Short Form (IIQ-7 SF)
Time frame: change from the baseline till 12 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Time frame: at 1 month post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Time frame: 3 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Time frame: 12 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Time frame: change from the baseline till 3 month post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Time frame: change from the baseline till 12 month post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Time frame: change from the baseline till 1 month post treatment
Marshall-Bonney test
Time frame: at 1 month post treatment
Marshall-Bonney test
Time frame: 3 months post treatment
Marshall-Bonney test
Time frame: 12 months post treatment
Marshall-Bonney test
Time frame: change from the baseline till 3 months post treatment
Marshall-Bonney test
Time frame: change from the baseline till 1 month post treatment
Marshall-Bonney test
Time frame: change from the baseline till 12 months post treatment
Pelvic Floor Distress Inventory (PFDI-20)
Time frame: 6 months post treatment
Pelvic floor organ prolapse quantification (POP-Q)
Time frame: 6 months post treatment
Marshall-Bonney test
Time frame: 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 37819368Szymanski JK, Starzec-Proserpio M, Bartosinska-Raczkiewicz D, Krawczyk A, Kukulski P, Jakiel G. Impact of preoperative pelvic floor muscle function on the success of surgical treatment of pelvic organ prolapse. Int Urogynecol J. 2024 Jan;35(1):85-93. doi: 10.1007/s00192-023-05653-8. Epub 2023 Oct 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorota Sys, PhD study chair
Centre of Postgraduate Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence and Pelvic Organ Prolapse, run by Żelazna Medical Centre, LLC at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Distress Inventory (PFDI-20) (time frame: change from the baseline till 6 months post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.