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

NCT00948103 | Completed Phase 3 DMC

• 1 other identifier: P050701
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Injection Site Vesicles

Keywords

Nitrous Oxide; Administration, Intravesical Drug; Botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Mean pain during intravesical injection

  5 minutes

Secondary Outcomes (2)

• Maximum pain during intravesical injection

  5 minutes

• Anxiety during intravesical injection

  5 minutes

Study Arms (2)

Oxygen

PLACEBO COMPARATOR

Drug: Oxygen

Nitrous Oxide

ACTIVE COMPARATOR

Drug: Nitrous Oxide

Interventions

Nitrous Oxide DRUG

nitrous oxide inhalation during intravesical injection. Dose depends on gender and pain

Nitrous Oxide

Oxygen DRUG

oxygen

Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Raymond Poincaré

Garches, 92380, France

Location

MeSH Terms

Interventions

Nitrous Oxide; Oxygen

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Officials

• Pierre DENYS, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

FR (1)