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

Primary Purpose

Overactive Bladder

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Botulinum toxin type A

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

A - 125 units

B - 250 units

C - 500 units

Arm Description

Outcomes

Primary Outcome Measures

Number of episodes of urgency and frequency of micturition.

Secondary Outcome Measures

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

Severity of urgency.

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

Standard International Continence Society (ICS) urodynamic parameters.

Quality of Life (QoL).

Safety

Extension study - Duration of effect as determined by the persistence of a positive response.

Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.

Extension study - Severity of urgency.

Extension study Quality of Life (QoL)

Extension study safety.

Full Information

NCT ID

NCT00578097

First Posted

December 18, 2007

Last Updated

November 21, 2019

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT00578097

Brief Title

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

Official Title

A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps 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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated early due to poor recruitment.

Study Start Date

February 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A - 125 units

Arm Type

Experimental

Arm Title

B - 250 units

Arm Type

Experimental

Arm Title

C - 500 units

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

AbobotulinumtoxinA (Dysport®)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of episodes of urgency and frequency of micturition.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Time Frame

All timepoints

Title

Severity of urgency.

Time Frame

All timepoints

Title

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

Time Frame

Day 4 and Week 6

Title

Standard International Continence Society (ICS) urodynamic parameters.

Time Frame

Week 12

Title

Quality of Life (QoL).

Time Frame

All timepoints

Title

Safety

Time Frame

All timepoints

Title

Extension study - Duration of effect as determined by the persistence of a positive response.

Time Frame

All timepoints

Title

Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.

Time Frame

All timepoints

Title

Extension study - Severity of urgency.

Time Frame

All timepoints

Title

Extension study Quality of Life (QoL)

Time Frame

All timepoints

Title

Extension study safety.

Time Frame

All timepoints

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Medical Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

ULB Hôpital Erasme

City

Brussels

ZIP/Postal Code

B-1070

Country

Belgium

Facility Name

CH Régional Huy - Polyclinique A Rue Trois Ponts

City

Huy

ZIP/Postal Code

2 4500

Country

Belgium

Facility Name

UZ Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHU Liege Sart Tilman

City

Liege

Country

Belgium

Facility Name

Urologická klinika

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Urologické oddělení

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Hôpital Michallon - CHU de Grenoble

City

Grenoble Cedex

ZIP/Postal Code

38043

Country

France

Facility Name

Groupe Hospitalier Pitié-Salpétrière

City

Paris Cedex 16

ZIP/Postal Code

75661

Country

France

Facility Name

Hôpital Charles Nicolle - CHU de Rouen

City

Rouen Cedex

ZIP/Postal Code

76031

Country

France

Facility Name

Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon

City

Saint Genis Laval

ZIP/Postal Code

69230

Country

France

Facility Name

Hôpital Rangueil - CHU de Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Medizinische Einrichtungen der RWTH

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Praxis für Urologie

City

Bad Kreuznach

ZIP/Postal Code

55543

Country

Germany

Facility Name

Praxis für Urologie

City

Emmendingen

ZIP/Postal Code

79312

Country

Germany

Facility Name

Praxis für Urologie

City

Günzburg

ZIP/Postal Code

89312

Country

Germany

Facility Name

Praxis für Urologie

City

Lahr

ZIP/Postal Code

77933

Country

Germany

Facility Name

Beckenboden Zentrum München

City

München

ZIP/Postal Code

81679

Country

Germany

Facility Name

Städtisches Klinikum Neunkirchen gGmbH

City

Neunkirchen

ZIP/Postal Code

66538

Country

Germany

Facility Name

Krankenhaus St. Trudpert

City

Pforzheim

ZIP/Postal Code

75177

Country

Germany

Facility Name

Unità Spinale, Azienda Ospedaliera Careggi

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Unità Spinale, Ospedale Niguarda

City

Milano

ZIP/Postal Code

20100

Country

Italy

Facility Name

Struttura Complessa di Neuro-Urologia

City

Torino

ZIP/Postal Code

1053

Country

Italy

Facility Name

General Urology Academisch Ziekenhuis Maastricht

City

Maastricht

State/Province

P.Debyelaan 25

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

VU Medisch Centrum Amsterdam

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

UMC St. Radboud

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Erasmus MC, Universitair Medisch Centrum Rotterdam

City

Rotterdam

ZIP/Postal Code

3000 CA

Country

Netherlands

Facility Name

Hospital Clínico Universitario Canarias

City

La Laguna

ZIP/Postal Code

38330

Country

Spain

Facility Name

Hospital San Rafael

City

Madrid

ZIP/Postal Code

28016

Country

Spain

Facility Name

Hospital Universitario La Fe

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Southmead Hospital

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Western General Hospital

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

St George's Hospital

City

London

ZIP/Postal Code

SW17 OQT

Country

United Kingdom

Facility Name

Churchill Hospital

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Royal Berkshire Hospital

City

Reading

ZIP/Postal Code

RG1 5AN

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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

Overactive Bladder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial