SYF09068485e70041558e8fa14a0ca4c983Registry ID: 2023-506372-27-00|Not Yet RecruitingPhase 3
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interventional
N/A
1 country
11
This is a phase 3, randomized, double blind, placebo-controlled, multi-center study aimed to establish the efficacy of botulinumtoxin-A (BoNT/A) injections in pelvic floor muscles in reducing pain in patients with chronic pelvic pain syndrome (CPPS).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2025
Actual (reported)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
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)
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
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
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)
Severity of AEs (mild, moderate, severe) (at each follow-up visit and phone interview)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
BOTOX 100 Allergan Units Powder for Solution for Injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
BOTOX 100 Allergan Units Powder for Solution for Injection
Named ingredient: Botulinum toxin type a
View registry recordFondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Milan, 20142, Italy
ASST Fatebenefratelli Sacco
Milan, 20157, Italy
Ubaldo Del Carro
First Submitted
February 28, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
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Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Ospedale San Raffaele S.r.l.
Milan, 20132, Italy
Istituto Auxologico Italiano
Milan, 20149, Italy
Azienda Provinciale Per I Servizi Sanitari
Trento, 38122, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Bergamo, 24127, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
ASST Melegnano e della Martesana - Vizzolo Predabissi
Vizzolo Predabissi (MI), 20070, Italy