Pelvic Floor DysfunctionsNCT07154576
Central Sensitization Inventory and Symptoms of Pelvic Floor Dysfunctions
An observational study of Pelvic Floor Dysfunctions, run by Żelazna Medical Centre, LLC at 1 site in Poland.
Trial summary
The goal of this observational study is to assess the values of Central Sensitization Inventory in women in a gynecology outpatient clinic. The main question it aims to answer is: Is there a relationship between outcomes of Central Sensitization Inventory and symptoms of pelvic floor dysfunctions reported by the… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunctions
- How many people
- 359 participants
- Where
- 1 sitePoland
- Study dates
- 28 Oct 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women attending gynecology outpatient clinic
Who may be able to join
- women attending gynecological outpatient clinics
- Agreement to participate
- Good command of spoken and written Polish
Who cannot join
- age below 18
- women who have undergone surgical treatment of pelvic organ prolapse or urinary incontinence
- Lack of consent to participate in the study
- Lack of good command of spoken and written Polish
- pregnancy
- women up to 6 months postpartum
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to assess the values of Central Sensitization Inventory in women in a gynecology outpatient clinic. The main question it aims to answer is:
Is there a relationship between outcomes of Central Sensitization Inventory and symptoms of pelvic floor dysfunctions reported by the patients?
Participants will complete questionnaires: Central Sensitization Inventory and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life (PFDI-20, PFIQ-7, PISQ-12).
Read the detailed description
Background: Pelvic floor dysfunctions are common disorders negatively impacting women's quality of life. However, there are differences when assessing prevalence due to the type of assessment. Prevalence of pelvic organ prolapse ranges between 1-65% of women; when assessing prevalence depending on symptoms, it can be 1-31%, but using anatomical examination, 1-50%, and finally, both of them - 20-65%.
Factors that are responsible for these discrepancies are still unknown. There are suggestions about correlations between central sensitivity syndrome (CSS) and differences in symptoms reported by patients, and the effect of surgical treatment.
Objectives: The aim of this study is to assess the values of Central Sensitization Inventory in women in gynecology outpatient clinic. Moreover, to examine if there is a relationship between those outcomes and symptoms of pelvic floor dysfunctions reported by the patients.
Material and methods: Women attending gynecological outpatient clinics will be invited to this study. Participants will be asked to complete the following questionnaires: Central Sensitization Inventory (CSI) and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life (PFDI-20, PFIQ-7, PISQ-12). Pelvic organ prolapse will be assessed using the POP-Q scale.
Expected results: To our knowledge, this will be the first study of this type conducted in Poland. Obtained results will provide preliminary, descriptive information on values of the Central Sensitization Inventory and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life. Data from this study may become a starting point for further, larger projects aimed at improving treatment of pelvic floor dysfunctions, including both physiotherapy and surgical treatment.
- Conditions
- Pelvic Floor Dysfunctions
- Keywords
- pelvic floor dysfunctions, pelvic organ prolapse, central sensitization inventory
- Medical subject headings
- Pelvic Organ Prolapse
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 |
|---|---|---|
| women attending gynecology outpatient clinic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory (CSI)
questionnaire which is divided into two parts A and B. The first contains 25 questions about symptoms, and 5 answers scored 0-4 for each, allowing for a score from 0 to 100. Part B contains information about the occurrence of diseases in the past
Measured: baseline measurement
Polish version of the Pelvic Floor Distress Inventory (PFDI-20)
Condition-specific questionnaire that will be used to assess how pelvic floor disorders affect quality of life. It consists of 3 scales, 20 questions. Every scale is scored from 0- no distress to 100 - the greatest distress. The scores from the 3 scales are summarized to achieve summary score (0-300)
Measured: baseline measurement
Pelvic Organ Prolapse Quantification (POP-Q) system
It is an objective, site-specific system that allows one to describe, quantify and stage pelvic support in women on a scale 0-4, 0 indicates no prolapse, while 4 indicates the most severe stage of pelvic organ prolapse.
Measured: baseline measurement
Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)
Condition-specific questionnaire that will be used to assess the impact of pelvic floor disorders on quality of life (daily activities, relationships and emotions). It consists of 3 scales which are scored 0-100. The results from the 3 scales are summarized to achieve the summary score (0-300). Higher numbers indicate greater impact.
Measured: baseline measurement
Polish version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
A condition-specific tool to assess sexual function in women with pelvic floor disorders. It contains 12 questions, where responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). 48 is the maximum score, where higher scores indicate better sexual function.
Measured: baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start28 Oct 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfunctionsStudies 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
- Cross-sectional
- Enrolment
- 359 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154576
- Sponsor's protocol ID
- PN/99/2024
- Status last verified
- Oct 2025
- First submitted
- 27 Aug 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sensitization Inventory and Symptoms of Pelvic Floor Dysfunctions
- ClinicalTrials.gov ID
- NCT07154576
- Acronym / sponsor ID
- PN/99/2024
- Conditions
- Pelvic Floor Dysfunctions
- Keywords
- pelvic floor dysfunctions, pelvic organ prolapse, central sensitization inventory
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 359 participants (estimated)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 4 Sep 2025 (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 goal of this observational study is to assess the values of Central Sensitization Inventory in women in a gynecology outpatient clinic. The main question it aims to answer is:
Is there a relationship between outcomes of Central Sensitization Inventory and symptoms of pelvic floor dysfunctions reported by the patients?
Participants will complete questionnaires: Central Sensitization Inventory and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life (PFDI-20, PFIQ-7, PISQ-12).
Detailed description
Background: Pelvic floor dysfunctions are common disorders negatively impacting women's quality of life. However, there are differences when assessing prevalence due to the type of assessment. Prevalence of pelvic organ prolapse ranges between 1-65% of women; when assessing prevalence depending on symptoms, it can be 1-31%, but using anatomical examination, 1-50%, and finally, both of them - 20-65%.
Factors that are responsible for these discrepancies are still unknown. There are suggestions about correlations between central sensitivity syndrome (CSS) and differences in symptoms reported by patients, and the effect of surgical treatment.
Objectives: The aim of this study is to assess the values of Central Sensitization Inventory in women in gynecology outpatient clinic. Moreover, to examine if there is a relationship between those outcomes and symptoms of pelvic floor dysfunctions reported by the patients.
Material and methods: Women attending gynecological outpatient clinics will be invited to this study. Participants will be asked to complete the following questionnaires: Central Sensitization Inventory (CSI) and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life (PFDI-20, PFIQ-7, PISQ-12). Pelvic organ prolapse will be assessed using the POP-Q scale.
Expected results: To our knowledge, this will be the first study of this type conducted in Poland. Obtained results will provide preliminary, descriptive information on values of the Central Sensitization Inventory and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life. Data from this study may become a starting point for further, larger projects aimed at improving treatment of pelvic floor dysfunctions, including both physiotherapy and surgical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women attending gynecology outpatient clinic | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women attending gynecology outpatient clinic
Key inclusion criteria (3 listed)
- women attending gynecological outpatient clinics
- Agreement to participate
- Good command of spoken and written Polish
Key exclusion criteria (6 listed)
- age below 18
- women who have undergone surgical treatment of pelvic organ prolapse or urinary incontinence
- Lack of consent to participate in the study
- Lack of good command of spoken and written Polish
- pregnancy
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
Central Sensitization Inventory (CSI)
Time frame: baseline measurement
questionnaire which is divided into two parts A and B. The first contains 25 questions about symptoms, and 5 answers scored 0-4 for each, allowing for a score from 0 to 100. Part B contains information about the occurrence of diseases in the past
Polish version of the Pelvic Floor Distress Inventory (PFDI-20)
Time frame: baseline measurement
Condition-specific questionnaire that will be used to assess how pelvic floor disorders affect quality of life. It consists of 3 scales, 20 questions. Every scale is scored from 0- no distress to 100 - the greatest distress. The scores from the 3 scales are summarized to achieve summary score (0-300)
Pelvic Organ Prolapse Quantification (POP-Q) system
Time frame: baseline measurement
It is an objective, site-specific system that allows one to describe, quantify and stage pelvic support in women on a scale 0-4, 0 indicates no prolapse, while 4 indicates the most severe stage of pelvic organ prolapse.
Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)
Time frame: baseline measurement
Condition-specific questionnaire that will be used to assess the impact of pelvic floor disorders on quality of life (daily activities, relationships and emotions). It consists of 3 scales which are scored 0-100. The results from the 3 scales are summarized to achieve the summary score (0-300). Higher numbers indicate greater impact.
Polish version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: baseline measurement
A condition-specific tool to assess sexual function in women with pelvic floor disorders. It contains 12 questions, where responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). 48 is the maximum score, where higher scores indicate better sexual function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pelvic Floor Dysfunctions, 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 6 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: enrolling by invitation, as of the sponsor's last update on 16 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Central Sensitization Inventory (CSI) (time frame: baseline measurement). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026.