Interstitial Cystitis, Bladder Pain Syndrome, Quality of LifeBPS/ICNCT05630742
Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis
An observational study of Interstitial Cystitis, Bladder Pain Syndrome, Quality of Life, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 82 years, women only
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome, Quality of Life
- What is being tested?
- chronic non-neoplastic pain
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Female Patients aged > 18 years diagnosis of BPS/IC or chronic non-neoplastic pain
Who cannot join
- bladder cancer
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- chronic non-neoplastic pain
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic non-neoplastic painOther
comparison of questionnaires scores
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: chronic non-neoplastic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 9 months
Secondary outcomes (1)
correlations between urological symptoms and psychiatric symptoms
PHQ-9: to investigate psychological symptoms, O'Leary Saint (ICSI-ICPI) to investigate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Nov 2021
- Primary completion31 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial Cystitis, Bladder Pain Syndrome, Quality of LifeStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Porru, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630742
- Sponsor's protocol ID
- quality of life in IC
- Acronym
- BPS/IC
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33367196Naliboff 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.
PubMed 26099876van 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.
PubMed 17900797
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Analysis in Bladder Pain Syndrome/Interstitial Cystitis: Implications for a Multimodal Integrated Treatment
- ClinicalTrials.gov ID
- NCT05630742
- Acronym / sponsor ID
- BPS/IC / quality of life in IC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstitial Cystitis | – | –patients with an existing diagnosis of BPS/IC. BPS/IC was confirmed by reviewing medical record. |
| control group | – | Other: chronic non-neoplastic painpatients with chronic non-neoplastic pain, suffering from fibromyalgia or other types of chronic pain (chronic arthralgia or lower back pain). |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Female Patients aged > 18 years diagnosis of BPS/IC or chronic non-neoplastic pain
Key exclusion criteria (2 listed)
- bladder cancer
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chronic non-neoplastic paincomparison of questionnaires scores | Other | control group |
Primary outcome
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
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
1 secondary outcome
correlations between urological symptoms and psychiatric symptoms
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 33367196McKernan 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.
- Background: PubMed 26099876Naliboff 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.
- Results publication: PubMed 17900797van 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis, Bladder Pain Syndrome, Quality of Life, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological symptoms and perception of pain affect every aspect of patients' life in IC (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05630742, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.