Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004097

Trial Description

start of 1:1-Block title

Title

Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MDT-301

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with
InterStim Therapy to treat fecal incontinence or constipation

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004097
  •   2012/08/09
  •   2005/09/12
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00200005  (ClinicalTrials.gov)
  •   Mdt-301 November 03,1998  (MedtronicNeuro)
  •   Mdt-301 (Nov 03, 98), 
  •   Amendment I (Dec 14, 99), 
  •   Amendment II (Jan 31, 02) 
  •   Amendment III (Jul 01, 2009) 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Fecal Incontinence and Constipation
  •   R15 -  Faecal incontinence
  •   K59.0 -  Constipation
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Device: Type: Implantable neurostimulator; InterStim
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying; time frame: Annually

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation - Improvement in Wexner constipation score; QOL.; time frame: Annually

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Austria
  •   Denmark
  •   Germany
  •   Netherlands
  •   Spain
  •   Sweden
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   1998/11/30
  •   140
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

140 patients (7 study groups, up to 20 implanted patients per study group)

Fecal Incontinence groups:

Main Inclusion Criteria:

- Fecal incontinence (defined as incontinence to solid or liquid stool > 1 / week);

- Failed biofeedback or medical therapy;

Groups 1 - 5 patients with:

- Group 1) Circumferentially intact external anal sphincter, no previous surgery;

- Group 2) Circumferentially intact external anal sphincter after surgical repair;

- Group 3) Rectal prolapse repaired with a rectopexy;

- Group 4) Spinal injury including disc prolapse;

- Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis

Constipation groups:

Main Inclusion Criteria:

- Chronic constipation (defined as </= 2 weekly bowel movements; and/or >25% of bowel
movements required straining; and/or >25% of bowel movements patient did not feel
empty afterwards) with symptoms more than 1 year

- Failed biofeedback or medical therapy;

Groups 6 - 7 patients with:

- Group 6) Idiopathic slow transit constipation as proven on colonic transit studies;

- Group 7) Normal colonic transit studies but chronic constipation due to either pelvic
floor dysfunction or disordered defecation.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

[---]*

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • MedtronicNeuro
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • University Hospital Erlangen- Erlangen, Germany
    • Klaus Matzel, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • University Hospital Erlangen- Erlangen, Germany
    • Klaus Matzel, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/09/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7.; 7475602
  •   Jarrett ME, Matzel KE, Stösser M, Baeten CG, Kamm MA. Sacral nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study. Dis Colon Rectum. 2005 Jun;48(6):1243-8.; 15793647
  •   Jarrett ME, Matzel KE, Christiansen J, Baeten CG, Rosen H, Bittorf B, Stösser M, Madoff R, Kamm MA. Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse. Br J Surg. 2005 Jun;92(6):734-9.; 15838899
  •   Jarrett ME, Matzel KE, Stösser M, Christiansen J, Rosen H, Kamm MA. Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer. Int J Colorectal Dis. 2005 Sep;20(5):446-51. Epub 2005 Apr 21.; 15843939
  •   Kamm MA, Dudding TC, Melenhorst J, Jarrett M, Wang Z, Buntzen S, Johansson C, Laurberg S, Rosen H, Vaizey CJ, Matzel K, Baeten C. Sacral nerve stimulation for intractable constipation. Gut. 2010 Mar;59(3):333-40. doi: 10.1136/gut.2009.187989.; 20207638
  •   Matzel KE, Kamm MA, Stösser M, Baeten CG, Christiansen J, Madoff R, Mellgren A, Nicholls RJ, Rius J, Rosen H. Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet. 2004 Apr 17;363(9417):1270-6.; 15094271
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.