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

NCT00578097 | Terminated Phase 2

• 2 other identifiers: Y-79-52120-1262007-002999-34
• Study Type: interventional
• Target: 81
• Locations: 8 countries
• Sites: 34

Brief Summary

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Number of episodes of urgency and frequency of micturition.

  Week 12

Secondary Outcomes (11)

• The number of episodes of urgency, frequency of micturition, and frequency of nocturia.

  All timepoints

• Severity of urgency.

  All timepoints

• Maximum flow rate and post-micturition residual volume (PMRV).

  Day 4 and Week 6

• Standard International Continence Society (ICS) urodynamic parameters.

  Week 12

• Quality of Life (QoL).

  All timepoints

Study Arms (4)

A - 125 units

EXPERIMENTAL

Biological: Botulinum toxin type A

B - 250 units

EXPERIMENTAL

Biological: Botulinum toxin type A

C - 500 units

EXPERIMENTAL

Biological: Botulinum toxin type A

D

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Botulinum toxin type A BIOLOGICAL

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.

Also known as: AbobotulinumtoxinA (Dysport®)

A - 125 units; B - 250 units; C - 500 units

Placebo DRUG

Single injection cycle, intradetrusor injection at baseline (visit 2).

D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (34)

ULB Hôpital Erasme

Brussels, B-1070, Belgium

Location

CH Régional Huy - Polyclinique A Rue Trois Ponts

Huy, 2 4500, Belgium

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

CHU Liege Sart Tilman

Liège, Belgium

Location

Urologická klinika

Olomouc, 775 20, Czechia

Location

Urologické oddělení

Prague, 140 00, Czechia

Location

Hôpital Michallon - CHU de Grenoble

Grenoble, 38043, France

Location

Groupe Hospitalier Pitié-Salpétrière

Paris, 75661, France

Location

Hôpital Charles Nicolle - CHU de Rouen

Rouen, 76031, France

Location

Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon

Saint-Genis-Laval, 69230, France

Location

Hôpital Rangueil - CHU de Toulouse

Toulouse, 31059, France

Location

Medizinische Einrichtungen der RWTH

Aachen, 52074, Germany

Location

Praxis für Urologie

Bad Kreuznach, 55543, Germany

Location

Praxis für Urologie

Emmendingen, 79312, Germany

Location

Praxis für Urologie

Günzburg, 89312, Germany

Location

Praxis für Urologie

Lahr, 77933, Germany

Location

Beckenboden Zentrum München

München, 81679, Germany

Location

Städtisches Klinikum Neunkirchen gGmbH

Neunkirchen, 66538, Germany

Location

Krankenhaus St. Trudpert

Pforzheim, 75177, Germany

Location

Unità Spinale, Azienda Ospedaliera Careggi

Florence, 50139, Italy

Location

Unità Spinale, Ospedale Niguarda

Milan, 20100, Italy

Location

Struttura Complessa di Neuro-Urologia

Torino, 1053, Italy

Location

General Urology Academisch Ziekenhuis Maastricht

Maastricht, P.Debyelaan 25, 6229 HX, Netherlands

Location

VU Medisch Centrum Amsterdam

Amsterdam, 1081 HV, Netherlands

Location

UMC St. Radboud

Nijmegen, 6525 GA, Netherlands

Location

Erasmus MC, Universitair Medisch Centrum Rotterdam

Rotterdam, 3000 CA, Netherlands

Location

Hospital San Rafael

Madrid, 28016, Spain

Location

Hospital Clínico Universitario Canarias

San Cristóbal de La Laguna, 38330, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

St George's Hospital

London, SW17 OQT, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Royal Berkshire Hospital

Reading, RG1 5AN, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

DE (8); CZ (2); BE (4); IT (3); GB (5); NL (4); FR (5); ES (3)