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

Sponsor
IRCCS Policlinico S. Matteo (Other)
Overall Status
Completed
CT.gov ID
NCT05630742
Collaborator
(none)
69
1
10
6.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
69 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis: Implications for a Multimodal Integrated Treatment
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Jul 31, 2022
Actual Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. psychological symptoms and perception of pain affect every aspect of patients' life in IC [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. [9 months]

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

Secondary Outcome Measures

  1. correlations between urological symptoms and psychiatric symptoms [9 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 82 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Female Patients aged > 18 years diagnosis of BPS/IC or chronic non-neoplastic pain

  • Exclusion Criteria:

bladder cancer

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology Dept. Policlinico an Matteo Pavia Pv Italy 27100

Sponsors and Collaborators

  • IRCCS Policlinico S. Matteo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Daniele Porru, MD, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT05630742
Other Study ID Numbers:
  • quality of life in IC
First Posted:
Nov 30, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2022