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

Condition(s) targeted: Overactive Bladder

Intervention: Botulinum type A (Dysport®) (Drug); Placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Benjamin Zakine, MD, Study Director, Affiliation: Ipsen

Overall contact:
Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com

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.

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.

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

Primary outcome: Number of episodes of urgency and frequency of micturition.

Secondary outcome:

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 QoL.

Extension study safety.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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.

Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com

UZ Gasthuisberg, Leuven 3000, Belgium; Recruiting

CH Régional Huy - Polyclinique A Rue Trois Ponts, Huy 2 4500, Belgium; Not yet recruiting

ULB Hôpital Erasme, Brussels B-1070, Belgium; Not yet recruiting

Urologické oddělení, Praha 4 140 00, Czech Republic; Recruiting

Urologická klinika, Olomouc 775 20, Czech Republic; Recruiting

Hôpital Charles Nicolle - CHU de Rouen, Rouen Cedex 76031, France; Recruiting

Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon, Saint Genis Laval 69230, France; Recruiting

Hôpital Michallon - CHU de Grenoble, Grenoble Cedex 38043, France; Recruiting

Hôpital Rangueil - CHU de Toulouse, Toulouse 31059, France; Recruiting

Groupe Hospitalier Pitié-Salpétrière, Paris Cedex 16 75661, France; Recruiting

Praxis für Urologie, Emmendingen 79312, Germany; Recruiting

Städtisches Klinikum Neunkirchen gGmbH, Neunkirchen 66538, Germany; Recruiting

Praxis für Urologie, Lahr 77933, Germany; Recruiting

Medizinische Einrichtungen der RWTH, Aachen 52074, Germany; Not yet recruiting

Praxis für Urologie, Bad Kreuznach 55543, Germany; Recruiting

Beckenboden Zentrum München, München 81679, Germany; Not yet recruiting

Krankenhaus St. Trudpert, Pforzheim 75177, Germany; Not yet recruiting

Praxis für Urologie, Günzburg 89312, Germany; Active, not recruiting

Unità Spinale, Ospedale Niguarda, Milano 20100, Italy; Not yet recruiting

Unità Spinale, Azienda Ospedaliera Careggi, Firenze 50139, Italy; Not yet recruiting

Struttura Complessa di Neuro-Urologia, Torino 1053, Italy; Not yet recruiting

VU Medisch Centrum Amsterdam, Amsterdam 1081 HV, Netherlands; Not yet recruiting

UMC St. Radboud, Nijmegen 6525 GA, Netherlands; Recruiting

Erasmus MC, Universitair Medisch Centrum Rotterdam, Rotterdam 3000 CA, Netherlands; Not yet recruiting

General Urology Academisch Ziekenhuis Maastricht, Maastricht, Netherlands; Recruiting
Dr Gommert van Koeveringe

Hospital San Rafael, Madrid 28016, Spain; Not yet recruiting

Hospital Clínico Universitario Canarias, La Laguna 38330, Spain; Not yet recruiting

Hospital Clínico Universitario, Santiago de Compostela 15706, Spain; Withdrawn

Hospital Universitario La Fe, Valencia 46009, Spain; Not yet recruiting

Churchill Hospital, Oxford OX3 7LJ, United Kingdom; Not yet recruiting

Western General Hospital, Edinburgh EH4 2XU, United Kingdom; Not yet recruiting

Southmead Hospital, Bristol BS10 5NB, United Kingdom; Not yet recruiting

Royal Berkshire Hospital, Reading RG1 5AN, United Kingdom; Not yet recruiting

St George's Hospital, London SW17 OQT, United Kingdom; Not yet recruiting

Starting date: February 2008
Ending date: October 2009
Last updated: October 20, 2008