Central Sensitization Inventory and Symptoms of Pelvic Floor Dysfunctions

NCT07154576 | Enrolling By Invitation

• 1 other identifier: PN/99/2024
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Pelvic Floor Dysfunctions

Keywords

pelvic floor dysfunctions; pelvic organ prolapse; central sensitization inventory

Outcome Measures

Primary Outcomes (5)

• 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

  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)

  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.

  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.

  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.

  baseline measurement

Study Arms (1)

women attending gynecology outpatient clinic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women attending gynecology outpatient clinic

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Żelazna Medical Centre, LLC: lead

Study Sites (1)

Żelazna Medical Center

Warsaw, 01-004, Poland

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2025-10

Locations

PL (1)