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

Overactive Bladder Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00578097
• Other study ID #: Y-79-52120-126
• Secondary ID: 2007-002999-34
• Status: Terminated
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Biological:
• Botulinum toxin type A
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.

Drug:
• Placebo
Single injection cycle, intradetrusor injection at baseline (visit 2).

Locations

Country	Name	City	State
Belgium	ULB Hôpital Erasme	Brussels
Belgium	CH Régional Huy - Polyclinique A Rue Trois Ponts	Huy
Belgium	UZ Gasthuisberg	Leuven
Belgium	CHU Liege Sart Tilman	Liege
Czechia	Urologická klinika	Olomouc
Czechia	Urologické oddelení	Praha 4
France	Hôpital Michallon - CHU de Grenoble	Grenoble Cedex
France	Groupe Hospitalier Pitié-Salpétrière	Paris Cedex 16
France	Hôpital Charles Nicolle - CHU de Rouen	Rouen Cedex
France	Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon	Saint Genis Laval
France	Hôpital Rangueil - CHU de Toulouse	Toulouse
Germany	Medizinische Einrichtungen der RWTH	Aachen
Germany	Praxis für Urologie	Bad Kreuznach
Germany	Praxis für Urologie	Emmendingen
Germany	Praxis für Urologie	Günzburg
Germany	Praxis für Urologie	Lahr
Germany	Beckenboden Zentrum München	München
Germany	Städtisches Klinikum Neunkirchen gGmbH	Neunkirchen
Germany	Krankenhaus St. Trudpert	Pforzheim
Italy	Unità Spinale, Azienda Ospedaliera Careggi	Firenze
Italy	Unità Spinale, Ospedale Niguarda	Milano
Italy	Struttura Complessa di Neuro-Urologia	Torino
Netherlands	VU Medisch Centrum Amsterdam	Amsterdam
Netherlands	General Urology Academisch Ziekenhuis Maastricht	Maastricht	P.Debyelaan 25
Netherlands	UMC St. Radboud	Nijmegen
Netherlands	Erasmus MC, Universitair Medisch Centrum Rotterdam	Rotterdam
Spain	Hospital Clínico Universitario Canarias	La Laguna
Spain	Hospital San Rafael	Madrid
Spain	Hospital Universitario La Fe	Valencia
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	St George's Hospital	London
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Royal Berkshire Hospital	Reading

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of urgency and frequency of micturition.		Week 12
Secondary	The number of episodes of urgency, frequency of micturition, and frequency of nocturia.		All timepoints
Secondary	Severity of urgency.		All timepoints
Secondary	Maximum flow rate and post-micturition residual volume (PMRV).		Day 4 and Week 6
Secondary	Standard International Continence Society (ICS) urodynamic parameters.		Week 12
Secondary	Quality of Life (QoL).		All timepoints
Secondary	Safety		All timepoints
Secondary	Extension study - Duration of effect as determined by the persistence of a positive response.		All timepoints
Secondary	Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.		All timepoints
Secondary	Extension study - Severity of urgency.		All timepoints
Secondary	Extension study Quality of Life (QoL)		All timepoints
Secondary	Extension study safety.		All timepoints