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

Sponsor
Ipsen (Industry)
Overall Status
Terminated
CT.gov ID
NCT00578097
Collaborator
(none)
81
Enrollment
34
Locations
4
Arms
22
Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Botulinum toxin type A
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A - 125 units

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.
Other Names:
  • AbobotulinumtoxinA (Dysport®)

    		•
    Experimental: B - 250 units

    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.
    Other Names:
  • AbobotulinumtoxinA (Dysport®)

    		•
    Experimental: C - 500 units

    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.
    Other Names:
  • AbobotulinumtoxinA (Dysport®)

    		•
    Placebo Comparator: D

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of episodes of urgency and frequency of micturition. [Week 12]

    Secondary Outcome Measures

    1. The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [All timepoints]

    2. Severity of urgency. [All timepoints]

    3. Maximum flow rate and post-micturition residual volume (PMRV). [Day 4 and Week 6]

    4. Standard International Continence Society (ICS) urodynamic parameters. [Week 12]

    5. Quality of Life (QoL). [All timepoints]

    6. Safety [All timepoints]

    7. Extension study - Duration of effect as determined by the persistence of a positive response. [All timepoints]

    8. Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [All timepoints]

    9. Extension study - Severity of urgency. [All timepoints]

    10. Extension study Quality of Life (QoL) [All timepoints]

    11. Extension study safety. [All timepoints]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 ULB Hôpital Erasme Brussels Belgium B-1070
    2 CH Régional Huy - Polyclinique A Rue Trois Ponts Huy Belgium 2 4500
    3 UZ Gasthuisberg Leuven Belgium 3000
    4 CHU Liege Sart Tilman Liege Belgium
    5 Urologická klinika Olomouc Czechia 775 20
    6 Urologické oddělení Praha 4 Czechia 140 00
    7 Hôpital Michallon - CHU de Grenoble Grenoble Cedex France 38043
    8 Groupe Hospitalier Pitié-Salpétrière Paris Cedex 16 France 75661
    9 Hôpital Charles Nicolle - CHU de Rouen Rouen Cedex France 76031
    10 Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon Saint Genis Laval France 69230
    11 Hôpital Rangueil - CHU de Toulouse Toulouse France 31059
    12 Medizinische Einrichtungen der RWTH Aachen Germany 52074
    13 Praxis für Urologie Bad Kreuznach Germany 55543
    14 Praxis für Urologie Emmendingen Germany 79312
    15 Praxis für Urologie Günzburg Germany 89312
    16 Praxis für Urologie Lahr Germany 77933
    17 Beckenboden Zentrum München München Germany 81679
    18 Städtisches Klinikum Neunkirchen gGmbH Neunkirchen Germany 66538
    19 Krankenhaus St. Trudpert Pforzheim Germany 75177
    20 Unità Spinale, Azienda Ospedaliera Careggi Firenze Italy 50139
    21 Unità Spinale, Ospedale Niguarda Milano Italy 20100
    22 Struttura Complessa di Neuro-Urologia Torino Italy 1053
    23 General Urology Academisch Ziekenhuis Maastricht Maastricht P.Debyelaan 25 Netherlands 6229 HX
    24 VU Medisch Centrum Amsterdam Amsterdam Netherlands 1081 HV
    25 UMC St. Radboud Nijmegen Netherlands 6525 GA
    26 Erasmus MC, Universitair Medisch Centrum Rotterdam Rotterdam Netherlands 3000 CA
    27 Hospital Clínico Universitario Canarias La Laguna Spain 38330
    28 Hospital San Rafael Madrid Spain 28016
    29 Hospital Universitario La Fe Valencia Spain 46009
    30 Southmead Hospital Bristol United Kingdom BS10 5NB
    31 Western General Hospital Edinburgh United Kingdom EH4 2XU
    32 St George's Hospital London United Kingdom SW17 OQT
    33 Churchill Hospital Oxford United Kingdom OX3 7LJ
    34 Royal Berkshire Hospital Reading United Kingdom RG1 5AN

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT00578097
    Other Study ID Numbers:
    • Y-79-52120-126
    • 2007-002999-34
    First Posted:
    Dec 20, 2007
    Last Update Posted:
    Nov 22, 2019
    Last Verified:
    Nov 1, 2019
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Nov 22, 2019