Treatment of Bladder Pain Syndrome with Onabotulinum toxin A

Phase 1

Conditions: Bladder Pain Syndrome
MedDRA version: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2014-001013-81-PT

Lead Sponsor: Centro Hospitalar de São João, EPE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

- Female patients aged between 20 and 60 years.
- Patients must have pain related to bladder filling, referred to bladder, urethra or perineum for at least 6 months with a score of at least 4 in a 0 (no pain) to 10 (maximum pain) visual analogue scale (VAS). Other urinary complaints such as frequency, urgency or nocturia may be present.
- For patients taking oral standard medication for their BPS/IC like PPS, amitriptyline or hydroxyzine must be discontinued at least 15 days prior to screening procedures and a treatment cannot be commenced during the study.
- For patients taking intravesical medication like heparinoids, PPS, chondrotin sulfate or DMSO medication must be discontinued at least 3 months prior to screening procedures and a treatment cannot be commenced during the study.
- Patients who have received Botulinum toxin type A or resiniferatoxin before, a period of at least 12 months must have elapsed prior to screening procedures. None of these two treatments can be concomitantly commenced during the study.
- If the patient is under analgesic medication (which includes paracetamol, non-steroidal anti-inflammatory drugs, gabapentin and pregabalin), she will be allowed at entry. However the dose must remain constant throughout the study duration. If the patient is off analgesic medication no de novo analgesic medication will be allowed during the study. However patients may receive analgesics once they withdraw the study.
- Patients must be able and be willing to use clean intermittent catheterization (CIC) at any time after study treatment, if it is determined to be necessary by the investigator.
- Anticoagulants, antiplatelet medications, or medications with anticoagulant effects (e.g., warfarin and other coumarinic derivatives, aspirin, clopidogrel, etc) will be prohibited prior to the administration of the study treatment within the following conditions stated in the guideline published by Douketis and colleagues (Douketis et al, 2012):
- Vitamin K antagonists will be interrupted for a minimum of 5 days before surgery.
- Antiplatelet/antiaggregant drug will be interrupted for a minimum of 7 days before surgery.
- These medications could be restarted the day following study treatment. If medically indicated, low molecular weight heparins (e.g. enoxaparin) will be permitted up to 24 hours prior to study drug treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or nursing patients
- Patients of childbearing potential that do not use adequate birth control methods (defined in Section 8.2.6)
- Patient has history or evidence of any pelvic or urological abnormalities including but not limited to the following:
- Current or frequent urinary tract infections (UTI) (> 2 in the last 6 months documented by urine culture) or is taking prophylactic antibiotics to prevent chronic UTI.
- History of bladder tumour with or without additional intravesical chemotherapy (mitomycin, BCG).
- History of previous pelvic radiotherapy, urinary tract tuberculosis, or exposure to ketamine.
- Current or previous non-investigated haematuria (patients with investigated haematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction of the investigator).
- Surgery or bladder diseases that may impact bladder function including bladder stones, stress incontinence, endometriosis, uterine prolapse, rectocele, cystocele or any pelvic surgery.
- Estimated creatinine clearance rate (eCCr) lower than 30 ml/min, calculated by the Cockcroft-Gault formula:
eCCr=((140-Age in years)×Mass (in kilograms))/(72×serum creatinine (in mg/dl))[×0.85 if female]
- Cardiac, pulmonary and hematologic conditions or other diseases that may preclude a safe general anaesthesia, in the opinion of the investigator.
- Patients at high risk of thrombotic events for whom suspension of antiplatelet or anticoagulant treatment puts patients’ safety at risk.
- Patient with a post void residual (PVR) urine volume of > 100 ml at screening.
- History of neuromuscular transmission disorders including, but not limited to myasthenia gravis and Eaton Lambert Syndrome
- Patients with peripheral motor neuropathic diseases including but not limited to amyotrophic lateral sclerosis.
- Allergy to OnabotA or any of the study treatments' componentes.
- Administration of OnabotA for other reasons than BPS/IC in the previous 12 weeks.