Interstitial Cystitis and Bladder Pain Syndrome
Conditions
Brief summary
This study will be conducted with the aim of ensuring the continued acceptability of the benefit-risk ratio and confirming the safety and performance of the device throughout its expected lifetime. Cystistat is supplied as a 50 mL solution containing 40 mg of sodium hyaluronate. It is indicated for the temporary replacement of the GAG layer in the bladder.
Detailed description
Real-world evidence observational studies are considered as an expedient tool to reflect the use of a product under real life conditions.
Interventions
DEVICEintravesical sodium hyaluronate (Cystistat®)
Cystistat will be instilled into the bladder according to the instructions for use and in line with the routine clinical practice.
Sponsors
MEDA Pharma GmbH & Co. KG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First prescription of Cystistat according to instructions for use. * Female patients of any ethnic origin with clinical diagnosis of interstitial cystitis (IC)/bladder pain syndrome (BPS). If in accordance with routine clinical practice at the site, ESSIC diagnostic criteria will be used. * Age: 18 years and older. * At least 6 months duration of bladder pain/discomfort symptom(s), e.g. constant bladder pain/discomfort or bladder pain/discomfort when voiding or as a burning sensation between voids as the bladder fills with urine. * At least one accompanying intermittent or persistent lower urinary tract symptom, such as urinary frequency, urgency, or nocturia during the previous 6 months. * Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) \> 18 prior to first treatment. * Written informed consent.
Exclusion criteria
* Known hypersensitivity reactions to sodium hyaluronate. * Pregnancy / planned pregnancy or breastfeeding during the course of this NIS. * Known history of any GAG substitution therapy within the last 2 years. * Known history of fulguration or resection of Hunner's lesions. * Known diagnosis of recurrent urinary tract infection or overactive bladder. * Any other conditions or diseases that can cause similar symptoms, using information from medical history, physical examination findings, laboratory studies (e.g., urine bacterial culture), and other previously performed procedures (e.g., urodynamics, cystoscopy, laparoscopy, radiological studies). * Patients are not able to fulfil study requirements according to physician's opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment (PGA) | Up to week 12 | For the primary analysis, a responder was defined as a participant who had an improvement on the PGA scale (i.e., PGA evaluated as markedly improved, moderately improved, or slightly improved. In case of slightly improved, participants were considered as responder only if the question Did therapy have a positive effect on your life, and would you undergo this treatment again? is answered with Yes.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score | Up to week 12 and additionally at Month 6 | The Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) is a validated questionnaire for the measurement of IC/BPS symptoms. It contains 8 questions and the total score ranges from 0 to 38, with higher scores indicating a worse situation |
| Assessment of Visual Analogue Scale (VAS) for Bladder Pain | Up to week 12 and additionally at Month 6 | Patients will be asked to assess their bladder pain on the VAS using the question How was your bladder pain over the last 3 days?. The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = no pain and 100 = worst possible pain. |
| Assessment of Visual Analogue Scale (VAS) for Urinary Urgency. | Up to week 12 and additionally at Month 6 | Patients will be asked to assess their urinary urgency on the VAS using the question How intense was urinary urgency over the last 3 days?. The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = no urgency and 100 = worst possible urgency. |
| Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL) | Up to week 12 and additionally at Month 6 | Patients will be asked to assess QoL on the VAS using the question How good or bad would you rate your overall health condition throughout the last 3 days?. The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = the worst health you can imagine and 100 = the best health you can imagine. |
Countries
Austria
Participant flow
Pre-assignment details
One patient did not receive study treatment due to withdrawal of consent.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm: Cystistat® 40 mg/50 mL Solution All participants received treatment per standard of care | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | Single Arm: Cystistat® 40 mg/50 mL Solution |
|---|---|
| Age, Continuous | 51.9 Years STANDARD_DEVIATION 17.15 |
| Bladder Pain/ Interstitial Cystitis Symptom Score | 29.3 score on a scale STANDARD_DEVIATION 4.58 |
| Race/Ethnicity, Customized Ethnicity African | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 67 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 5 Participants |
| Region of Enrollment Europe | 73 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 1 Participants |
| Visual Analogue Scale (bladder pain) | 74.7 units on a scale STANDARD_DEVIATION 18.7 |
| Visual Analogue Scale (quality of life) | 53.1 units on a scale STANDARD_DEVIATION 28.9 |
| Visual Analogue Scale (urinary urgency) | 75.2 units on a scale STANDARD_DEVIATION 21.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 73 |
| other Total, other adverse events | 13 / 73 |
| serious Total, serious adverse events | 1 / 73 |
Outcome results
Primary
Patient Global Assessment (PGA)
For the primary analysis, a responder was defined as a participant who had an improvement on the PGA scale (i.e., PGA evaluated as markedly improved, moderately improved, or slightly improved. In case of slightly improved, participants were considered as responder only if the question Did therapy have a positive effect on your life, and would you undergo this treatment again? is answered with Yes.).
Time frame: Up to week 12
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm: Cystistat® 40 mg/50 mL Solution | Patient Global Assessment (PGA) | 90.1 percentage of participants (%) |
Secondary
Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score
The Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) is a validated questionnaire for the measurement of IC/BPS symptoms. It contains 8 questions and the total score ranges from 0 to 38, with higher scores indicating a worse situation
Time frame: Up to week 12 and additionally at Month 6
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score | End of treatment or latest week 12 | -13.8 score on a scale (change from baseline) | Standard Deviation 8.62 |
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score | Month 6 | -15.3 score on a scale (change from baseline) | Standard Deviation 9.15 |
Secondary
Assessment of Visual Analogue Scale (VAS) for Bladder Pain
Patients will be asked to assess their bladder pain on the VAS using the question How was your bladder pain over the last 3 days?. The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = no pain and 100 = worst possible pain.
Time frame: Up to week 12 and additionally at Month 6
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Visual Analogue Scale (VAS) for Bladder Pain | End of treatment or latest week 12 | -42.0 units on a scale (change from baseline) | Standard Deviation 27.49 |
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Visual Analogue Scale (VAS) for Bladder Pain | Month 6 | -49.2 units on a scale (change from baseline) | Standard Deviation 29.69 |
Secondary
Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL)
Patients will be asked to assess QoL on the VAS using the question How good or bad would you rate your overall health condition throughout the last 3 days?. The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = the worst health you can imagine and 100 = the best health you can imagine.
Time frame: Up to week 12 and additionally at Month 6
Population: Full anaylsis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL) | End of treatment or latest week 12 | 17.1 units on a scale (change from baseline) | Standard Deviation 35.84 |
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL) | Month 6 | 27.2 units on a scale (change from baseline) | Standard Deviation 33.27 |
Secondary
Assessment of Visual Analogue Scale (VAS) for Urinary Urgency.
Patients will be asked to assess their urinary urgency on the VAS using the question How intense was urinary urgency over the last 3 days?. The VAS will be an unmarked line ranging from 0 to 100 mm, where 0 = no urgency and 100 = worst possible urgency.
Time frame: Up to week 12 and additionally at Month 6
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Visual Analogue Scale (VAS) for Urinary Urgency. | Month 6 | -49.2 units on a scale (change from baseline) | Standard Deviation 30.48 |
| Single Arm: Cystistat® 40 mg/50 mL Solution | Assessment of Visual Analogue Scale (VAS) for Urinary Urgency. | End of treatment or latest week 12 | -39.3 units on a scale (change from baseline) | Standard Deviation 28.9 |