Central Sensitization Inventory and Symptoms of Pelvic Floor Dysfunctions

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).

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Key information

Conditions

Pelvic Floor Dysfunctions Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Żelazna Medical Center

Warsaw, 01-004, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

women attending gynecological outpatient clinics
Agreement to participate
Good command of spoken and written Polish

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Żelazna Medical Centre, LLC

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 4, 2025
Registry last updated: Apr 16, 2026

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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