The Interest of the Nitrous Oxide During Intravesical Injection of Botulinum Toxin A

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Second line treatment for detrusor hyperreflexia is the intravesical BTX-A injections. First 300 units Botox are diluted with 30 ml of preservative-free saline. Using a rigid cystoscope and an injection needle, BTX-A is injected into 30 sites within the detrusor muscle.

The used of KALINOX® (50% nitrous oxide and oxygen) inhalation has demonstrated analgesic efficacy in various procedures (obstetric, liver biopsy, transrectal ultrasound guided prostate biopsy, emergency) The aim of this study is to investigate the safety and efficacy of analgesia with N2O/O2 inhalation for detrusor BTX-A injections using a rigid cystoscope.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Botulinum Toxins; Nitrous Oxide

Criteria

Inclusion Criteria:

• Man or woman of more than 18 years

• Patient with overactive bladder

• First intravesical Botulinum injection

• Bladder sensitivity on the urodynamic

• Patient not presenting contraindication to this injection

• Cystoscopy realized before the injection of botulinal toxin A

• Negative pregnancy test for women of child-bearing age

• Signing of an informed consent form, after appropriate information has been provided

Exclusion Criteria:

• Pregnancy

• Contraindication in the toxin such as severe myasthenia, syndrome of Eaton-Lambert, or amyotrophic lateral sclerosis

• Treatment antibiotic by aminoglycoside

• Allergies known about the toxin, about the anesthetics used during the study

• Patients under anticoagulants, or having taken a treatment anti-aggregant platelet in 10 days preceding the injection

• Haemophilia or deficit in factor of the coagulation responsible for disorder of the haemostasis

• Current urinary infection defined in the ECBU by a superior bacteriuria in 10°5 / ml and a leucocyturia superior to 10°4 / ml

• Current genital infection or in four weeks preceding the injection

• Histories of irradiation pelvic or treatment in the course of a neoplasia

• Current treatment or in six months preceding the randomisation by a pharmacological ENDOVESICAL agent

• Patients requiring a ventilation in pure oxygen

• Intra-cranial high blood pressure

• Conscience alteration

• Lung diseases

• Bubbles of emphysema

• Gaseous embolism

• Accident of dive

• Abdominal gaseous distension

• Patient having received recently an ophthalmic gas (SF6, C3F8, C2F6) used in the eye surgery as long as persists a bubble of gas inside the eye and at least during a period of 3 months

• Facial traumatism

• Chronic respiratory failure

• Analgesic treatment by morphine or morphine agonists of class 3

• Psychiatric pathology interfering with the compliance to the protocol or not allowing a correct evaluation of the result

• Patient having participated in a clinical study in 3 months preceding the inclusion

• No affiliation to any social insurance system