Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder - Full Text View

Purpose

The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.

Condition	Intervention	Phase
Overactive Bladder	Drug: Botulinum type A (Dysport®) Other: Placebo	Phase II

MedlinePlus related topics:

Botox

ChemIDplus related topics:

Clostridium botulinum toxin BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase II, International, Multi-Centre, Prospective, Randomised, Parallel-Group, Double-Blind, Dose-Ranging, Placebo-Controlled, 12-Week, Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-Month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.

Further study details as provided by Ipsen:

Primary Outcome Measures:

Number of episodes of urgency and frequency of micturition. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Maximum flow rate and post-micturition residual volume (PMRV). [ Time Frame: Day 4 and Week 6 ] [ Designated as safety issue: No ]
Standard International Continence Society (ICS) urodynamic parameters. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Quality of Life (QoL). [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Safety [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]
Extension study - Duration of effect as determined by the persistence of a positive response. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study - Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study QoL. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
Extension study safety. [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	301
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A - 125 units: Experimental	Drug: Botulinum type A (Dysport®) Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
B - 250 units: Experimental	Drug: Botulinum type A (Dysport®) Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
C - 500 units: Experimental	Drug: Botulinum type A (Dysport®) Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
D: Placebo Comparator	Other: Placebo Single injection cycle, intradetrusor injection at baseline (visit 2).

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.

Exclusion Criteria:

Bladder outlet obstruction (on urodynamic assessment).
Post-Micturition Residual Volume > 150 ml (ultrasound assessment).
Evidence of a urinary tract infection at Screening or Baseline in the study.
Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578097

Contacts


Contact: Ipsen Recruitment Enquiries		clinical.trials@ipsen.com

Locations


Belgium
	UZ Gasthuisberg	Recruiting
	Leuven, Belgium, 3000
	CH Régional Huy - Polyclinique A Rue Trois Ponts	Not yet recruiting
	Huy, Belgium, 2 4500
	ULB Hôpital Erasme	Not yet recruiting
	Brussels, Belgium, B-1070

Czech Republic
	Urologické oddělení	Not yet recruiting
	Praha 4, Czech Republic, 140 00
	Urologická klinika	Not yet recruiting
	Olomouc, Czech Republic, 775 20

France
	Hôpital Charles Nicolle - CHU de Rouen	Not yet recruiting
	Rouen Cedex, France, 76031
	Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon	Not yet recruiting
	Saint Genis Laval, France, 69230
	Hôpital Michallon - CHU de Grenoble	Not yet recruiting
	Grenoble Cedex, France, 38043
	Hôpital Rangueil - CHU de Toulouse	Not yet recruiting
	Toulouse, France, 31059
	Groupe Hospitalier Pitié-Salpétrière	Not yet recruiting
	Paris Cedex 16, France, 75661

Germany
	Praxis für Urologie	Not yet recruiting
	Emmendingen, Germany, 79312
	Städtisches Klinikum Neunkirchen gGmbH	Not yet recruiting
	Neunkirchen, Germany, 66538
	Praxis für Urologie	Not yet recruiting
	Lahr, Germany, 77933
	Krankenhaus St. Trudpert	Not yet recruiting
	Pforzheim, Germany, 75177
	Praxis für Urologie	Not yet recruiting
	Bad Kreuznach, Germany, 55543
	Beckenboden Zentrum München	Not yet recruiting
	München, Germany, 81679
	Medizinische Einrichtungen der RWTH	Not yet recruiting
	Aachen, Germany, 52074
	Praxis für Urologie	Not yet recruiting
	Günzburg, Germany, 89312

Italy
	Unità Spinale, Ospedale Niguarda	Not yet recruiting
	Milano, Italy, 20100
	Unità Spinale, Azienda Ospedaliera Careggi	Not yet recruiting
	Firenze, Italy, 50139
	Struttura Complessa di Neuro-Urologia	Not yet recruiting
	Torino, Italy, 1053

Netherlands
	VU Medisch Centrum Amsterdam	Not yet recruiting
	Amsterdam, Netherlands, 1081 HV
	UMC St. Radboud	Not yet recruiting
	Nijmegen, Netherlands, 6525 GA
	Erasmus MC, Universitair Medisch Centrum Rotterdam	Not yet recruiting
	Rotterdam, Netherlands, 3000 CA
	General Urology Academisch Ziekenhuis Maastricht	Recruiting
	Maastricht, Netherlands
	Contact: Dr Gommert van Koeveringe

Spain
	Hospital San Rafael	Not yet recruiting
	Madrid, Spain, 28016
	Hospital Clínico Universitario Canarias	Not yet recruiting
	La Laguna, Spain, 38330
	Hospital Clínico Universitario	Not yet recruiting
	Santiago de Compostela, Spain, 15706
	Hospital Universitario La Fe	Not yet recruiting
	Valencia, Spain, 46009

United Kingdom
	Churchill Hospital	Not yet recruiting
	Oxford, United Kingdom, OX3 7LJ
	St George's Hospital	Not yet recruiting
	London, United Kingdom, SW17 OQT
	Southmead Hospital	Not yet recruiting
	Bristol, United Kingdom, BS10 5NB
	Royal Berkshire Hospital	Not yet recruiting
	Reading, United Kingdom, RG1 5AN
	Western General Hospital	Not yet recruiting
	Edinburgh, United Kingdom, EH4 2XU

Sponsors and Collaborators

Ipsen

Investigators


Study Director:	Benjamin Zakine, MD	Ipsen

More Information

Study ID Numbers:	Y-97-52120-126
First Received:	December 18, 2007
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00578097
Health Authority:	France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: State Institute for Drug Control; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Signs and Symptoms

Urinary Bladder, Overactive

Botulinum Toxins

Urologic Diseases

Urinary Bladder Diseases

Botulinum Toxin Type A

Additional relevant MeSH terms:

Urological Manifestations

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Neuromuscular Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00578097