Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC)

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis, Bladder Pain Syndrome, Quality of Life
• Intervention / Treatment: Other: chronic non-neoplastic pain

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Italy
  • Pv
    • Pavia, Pv, Italy, 27100
      • Urology Dept. Policlinico an Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Group 1: patients with an existing diagnosis of BPS/IC. We confirmed presence of BPS/IC by reviewing medical record.

Group 2: patients with chronic non-neoplastic pain, suffering from fibromyalgia or other types of chronic pain (chronic arthralgia or lower back pain).

Description

Inclusion Criteria:

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

bladder cancer

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Interstitial Cystitis; patients with an existing diagnosis of BPS/IC. BPS/IC was confirmed by reviewing medical record.
control group; patients with chronic non-neoplastic pain, suffering from fibromyalgia or other types of chronic pain (chronic arthralgia or lower back pain).	Other: chronic non-neoplastic pain; comparison of questionnaires scores

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychological symptoms and perception of pain affect every aspect of patients' life in IC	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	9 months
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.	PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlations between urological symptoms and psychiatric symptoms	PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate	9 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo

Publications and helpful links

General Publications

• McKernan LC, Bonnet KR, Finn MTM, Williams DA, Bruehl S, Reynolds WS, Clauw D, Dmochowski RR, Schlundt DG, Crofford LJ. Qualitative Analysis of Treatment Needs in Interstitial Cystitis/Bladder Pain Syndrome: Implications for Intervention. Can J Pain. 2020;4(1):181-198. doi: 10.1080/24740527.2020.1785854. Epub 2020 Sep 1.
• Naliboff BD, Stephens AJ, Afari N, Lai H, Krieger JN, Hong B, Lutgendorf S, Strachan E, Williams D; MAPP Research Network. Widespread Psychosocial Difficulties in Men and Women With Urologic Chronic Pelvic Pain Syndromes: Case-control Findings From the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network. Urology. 2015 Jun;85(6):1319-27. doi: 10.1016/j.urology.2015.02.047.
• van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne JL, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele JJ. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008 Jan;53(1):60-7. doi: 10.1016/j.eururo.2007.09.019. Epub 2007 Sep 20.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Syndrome; Cystitis; Somatoform Disorders; Cystitis, Interstitial
• Other Study ID Numbers: quality of life in IC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No