BOTULINUM TOXIN TYPE A for Chronic pelvic pain syndrome

Inclusion criteria

• {"criterion_text":"- age ≥ 18 years"}
• {"criterion_text":"- Subject able to express consent to participate in the study"}
• {"criterion_text":"- CPPS diagnosis according to the European Association of Urology (EAU) guidelines"}
• {"criterion_text":"- mean of the worst daily pain intensity ≥4 in a PI-NRS for a period of one week within the month preceding V1"}
• {"criterion_text":"- Failure of at least one intervention for chronic pelvic pain (CPP) according to the current best clinical practice"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- Raised post void residual >150 ml at any time in the 6 months prior to screening"}
• {"criterion_text":"- History of botulinumtoxin injections in the previous 6 months"}
• {"criterion_text":"- Recognized hypersensitivity to botulinumtoxin or to any component of toxin formulation or known botulinumtoxin resistance"}
• {"criterion_text":"- Infection at the proposed injection sites"}
• {"criterion_text":"- Concomitant oral drugs that could interfere with botulinum toxin action, such as aminoglycosides, baclofen or diazepam"}
• {"criterion_text":"- Presence of ongoing pelvic pathology"}
• {"criterion_text":"- Presence of neurological disorders"}
• {"criterion_text":"- Previous or actual major depressive disorder"}
• {"criterion_text":"- Bleeding disorders or current anticoagulant medications"}
• {"criterion_text":"- Previous surgical procedures or trauma on pelvic organs"}
• {"criterion_text":"- Previous or current chemotherapy or radiotherapy on pelvic organs"}
• {"criterion_text":"- Urinary or fecal incontinence within 3 months prior to screening"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients considered to be responders (defined as ≥ 30% reduction in pain intensity compared to the baseline) at week 4 in the BoNT/A-treated group versus the placebo group. Pain intensity is rated with Pain Intensity Numeric Rating Scale (PI-NRS) on a 7-day pain diary (mean of the worst daily pain intensity over the 7 preceding days) compared to a 7-day baseline period","definition_or_measurement_approach":"Responder defined as ≥30% reduction in pain intensity versus baseline at week 4. Pain intensity measured using Pain Intensity Numeric Rating Scale (PI-NRS) recorded in a 7-day pain diary (mean of the worst daily pain intensity over the 7 days) compared to a 7-day baseline period."}

Secondary endpoints

• {"endpoint_text":"- Proportion of responders in the BoNT/A-treated group versus the placebo group at other scheduled assessments (i.e. week 2, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24)","definition_or_measurement_approach":"Responder = as defined for primary; assessed at multiple scheduled time points (weeks 2, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24)."}
• {"endpoint_text":"- Change (%) in amount of rescue medication taken, evaluated on a 7-day diary filled-out the week before each scheduled visits (i.e. week 4, 8, 12, 16, 20, 24) compared to the baseline","definition_or_measurement_approach":"Percent change versus baseline in rescue medication use recorded in 7-day diary the week before scheduled visits at specified weeks."}
• {"endpoint_text":"- Change in DN4 questionnaire and in Pelvic Floor Muscles Hyperalgesia (PFMH) score at each scheduled visits (i.e. week 4, 8, 12, 16, 20, 24) compared to the baseline","definition_or_measurement_approach":"Change from baseline in DN4 questionnaire and PFMH score measured at scheduled visits (weeks 4, 8, 12, 16, 20, 24)."}
• {"endpoint_text":"- Incidence of adverse events (AEs) (total AEs, new/or worsened urinary incontinence, new/or worsened urinary retention, new/or worsened fecal incontinence, new/or worsened constipation, other AEs) (at each follow-up visit and phone interview)","definition_or_measurement_approach":"Incidence and types of AEs collected at each follow-up visit and phone interview; includes specific urinary/gastrointestinal events."}
• {"endpoint_text":"- Severity of AEs (mild, moderate, severe) (at each follow-up visit and phone interview)","definition_or_measurement_approach":"AE severity graded (mild/moderate/severe) and recorded at visits and phone interviews."}
• {"endpoint_text":"- Change in International Prostate Symptom Score (IPSS), Wexner score, Female Sexual Distress Scale (FSDS) and International Index of Erectile Function (IIEF) score at scheduled visits (i.e. week 4, 8, 12, 16, 20, 24) compared to the baseline","definition_or_measurement_approach":"Change from baseline in specified validated questionnaires (IPSS, Wexner, FSDS, IIEF) measured at scheduled visits."}
• {"endpoint_text":"- Change in Short Form 12 Health Survey (SF-12) score at scheduled visits (i.e. week 4, 8, 12, 16, 20, 24) compared to the baseline","definition_or_measurement_approach":"Change from baseline in SF-12 score measured at scheduled visits."}

Italy

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

17-06-2025

Processing Time Days

75

Number Of Sites

11

Number Of Participants

110

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy