Central Sensitization Inventory and Symptoms of Pelvic Floor Dysfunctions

Not yet recruiting

• Conditions: Pelvic Floor Dysfunctions

• Registration Number: NCT07154576
• Lead Sponsor: Żelazna Medical Centre, LLC

Brief Summary

The goal of this observational study is to assess the values of Central Sensitization Inventory in women in gynecology outpatient clinic. The main question it aims to answer is:

Is there a relatoinship 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 type of assessment. Prevalence of pelvic organ prolapse range 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. They will be asked to complete 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 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 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 improve treatment of pelvic floor dysfunctions, including both physiotherapy and surgical treatment.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Start: 2025-09-10
• Primary Completion: 2026-05-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 359

Inclusion Criteria

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

Exclusion Criteria

• age below 18
• women after 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 till 6 months postpartum

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Sensitization Inventory (CSI)	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)	baseline measurement	Condition-specific questionnaire will be used to assess how pelvic floor disorders affect quality of life. It consist of 3 scales, 20 questions. Every scale is scored from 0- no distress to 100 - the greatest distress. The scores from 3 scales are summarized to achieve summary score (0-300)
Pelvic Organ Prolapse Quantification (POP-Q) system	baseline measurement	It is a objective, site-specific system that allows describe, quantify and stage pelvic support in women iin scale 0-4, 0 indicates no prolapse, 4 indicates the most severe stage of pelvic organ prolapse.
Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)	baseline measurement	Condition-specific questionnaire, will be used to assess 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 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)	baseline measurement	condition-specific tool to assess sexual function in women with pelvic floor disorders. 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.

Trial Locations

Locations (1)

Żelazna Medical Center; 🇵🇱 Warsaw, Poland