Trial document





This trial has been registered retrospectively.
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  DRKS00014794

Trial Description

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Title

Oxytocin administration in High Intensity Focused Ultrasound (HIFU) treatment of myomata - utility oxytocin during HIFU treatment

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Objectives
The aim of the study was to evaluate the clinical efficacy of magnetic resonance-guided High Intensity Focused Ultrasound (HIFU) in patients with symptomatic uterine fibroids (myomata) after application of oxytocin.
Methods
156 women with symptomatic uterine fibroids were treated using MR-guided HIFU procedure. 51 patients had additional IV administration of 40 IU of oxytocin in 5% Glucose or 0,9% NaCl solution during therapy. Before and after the procedure we performed MR and measured initial perfused volume, final perfused volume, non-perfused volume (NPV), and treated volume ratio (TVR). The follow-up was up to 15 months to assess efficacy of treatment and relief of symptoms.
Results
Non-perfused volume was statistically significantly larger in oxytocin group than in control group (p=0.0019). The remaining parameters did not show significant difference between both groups.
Conclusion
Oxytocin administration seems to improve efficiency of HIFU therapy although further research is required to assess its value.

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Brief Summary in Scientific Language

51 patients with fibroids were performed HIFU (High Intensity Focused Ultrasound) with application 40 units oxytocin with 0.9% NACL solution during treatment. Non-perfused volume, volume of fibroids after procedure were evaluated.

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Organizational Data

  •   DRKS00014794
  •   2018/06/05
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  •   yes
  •   Approved
  •   38/B/2017, District Ethics Committee Polish Medical Society
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Secondary IDs

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Health Condition or Problem studied

  •   D25 -  Leiomyoma of uterus
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Interventions/Observational Groups

  •   51 patients during HIFU treatment were performed oxytocin administration 40 units with 0,9% NACL solution.
  •   105 patients with uterus fibroids were performed HIFU treatment without medicines.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Non-perfused volume measured after treatment,
volume of fibroids measured 6 month after procedure

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Secondary Outcome

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Countries of Recruitment

  •   Poland
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/05/26
  •   151
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   22   Years
  •   43   Years
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Additional Inclusion Criteria

Symptomatic fibroids, size <13 cm

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Exclusion Criteria

Fibroids size >13cm, non-symptomatic

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Szpital Pro-Familia
    • Mr.  Tomasz  Łoziński 
    • Witolda 6b
    • 35302  Rzeszów
    • Poland
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    • Szpital Pro-Famiia
    • Mr.  phd.md  Tomasz  Łoziński 
    • Witolda 6b
    • 35-302  Rzeszów
    • Poland
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    • Szpital Pro-Famiia
    • Mr.  Tomasz  Łoziński 
    • Witolda 6b
    • 35302  Rzeszów
    • Poland
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Sources of Monetary or Material Support

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    • NCBiR National center Reaserch&Developing
    • Nowogrodzka 47a
    • 00-695  Warsaw
    • Poland
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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/20
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Trial Publications, Results and other Documents

  •   evidence of ethical approval
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* This entry means the parameter is not applicable or has not been set.