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Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis

NCT ID: NCT05630742

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Interstitial Cystitis, Bladder Pain Syndrome, Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Interstitial Cystitis

patients with an existing diagnosis of BPS/IC. BPS/IC was confirmed by reviewing medical record.

No interventions assigned to this group

control group

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

chronic non-neoplastic pain

Intervention Type OTHER

comparison of questionnaires scores

Interventions

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chronic non-neoplastic pain

comparison of questionnaires scores

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female Patients aged \> 18 years diagnosis of BPS/IC or chronic non-neoplastic pain

Exclusion Criteria

bladder cancer

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Daniele Porru

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Urology Dept. Policlinico an Matteo

Pavia, Pv, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 33367196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26099876 (View on PubMed)

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.

Reference Type RESULT
PMID: 17900797 (View on PubMed)

Other Identifiers

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quality of life in IC

Identifier Type: -

Identifier Source: org_study_id