Skip to main content
OpenTrials
Completed

NCT Number: NCT05630742

Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis

The aim of our study was to evaluate whether there is a higher prevalence of anxiety-depressive disorders in women with interstitial cystitis than in women with chronic non-neoplastic pain with or without fibromyalgia, to examine possible correlations between urological and psychiatric symptoms, analyze how urological symptoms affect psychological dimension, and how specific stress or trauma can contribute to the onset of interstitial cystitis.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–82 year

Sex eligibility

Female

Study type

Observational

Primary location

Urology Dept. Policlinico an Matteo

Pavia, Pv, 27100, Italy

About this study

The survey included 69 patients, 42 patients had a diagnosis of Bladder Pain Syndrome/Interstitial Cystitis while 27 of them had chronic non-neoplastic pain. The comparison of the total values of the PHQ-9 between the two groups, 1 versus 2, in relation to final score of PHQ-9, the average PHQ-9 score was 10.3 in group 1, therefore a value greater than 9, considered as major depression (score between 10 and 14); the average score of PHQ-9 was 6.9 in group 2, as in sub-threshold depression (between 5-9). Correlation between PHQ-9 and BPI was also evaluated, the relation was significant only in interstitial cystitis with regard to the following spheres: daily life, work activity, pleasure of life, mood, sleep quality, pain intensity, and urinary symptoms. Based on these data, when PHQ-9 score increases, and depressive symptoms worsen, there is interference with daily life and work activity, pleasure of living, mood, quality of sleep, perception of intensity of pain and urinary symptoms. Patients who had onset of psychiatric symptoms following diagnosis (both interstitial cystitis and other painful syndromes) had an average PHQ-9 score of 11.7 compared to the score of 8.3 of patients without onset of psychiatric symptoms after diagnosis (p = 0.0464), so it may be that depressive symptoms starting after the diagnosis of pain syndrome are more severe. Women who undergo psychiatric-psychological consultation and therapy have an average O'Leary score 20.4 compared to 25.8 in those who are not under psychiatric consultation (p = 0.0418). This emphasizes how psychosocial support can improve perception of pain and urinary symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female Patients aged > 18 years diagnosis of BPS/IC or chronic non-neoplastic pain
  • Exclusion Criteria:

bladder cancer

-

Treatment and study plan

chronic non-neoplastic pain

Other

comparison of questionnaires scores

Primary outcomes

  1. psychological symptoms and perception of pain affect every aspect of patients' life in IC

    Time frame: 9 months

    PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate urological symptoms only for women with I.C and BPI questionnaires were administered

  2. Examine whether there is a higher prevalence of anxiety-depressive disorders in women with interstitial cystitis than in women with chronic non-neoplastic pain with or without fibromyalgia.

    Time frame: 9 months

    PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate

Secondary outcomes

  1. correlations between urological symptoms and psychiatric symptoms

    Time frame: 9 months

    PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis: Implications for a Multimodal Integrated Treatment

Acronym: BPS/IC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2022
Registry last updated
Nov 30, 2022

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.

Published trials that share one or more normalized conditions with this study.