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NCT Number: NCT07808034

The Efficacy of High-Intensity Focused Ultrasound Therapy on Adenomyosis

To assess the efficacy of High-Intensity Focused Ultrasound on adenomyosis

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location contact

Sheng-Mou Hsiao, M.D.

CONTACT

[email protected]

+886-2-89667000 ext. 1818

About this study

Patients and methods:

All outpatient patients with adenomyosis who will receive High-Intensity Focused Ultrasound therapy will be invited to participate in this study. The size and location of adenomyosis and the uterus should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete visual analog scale of the severity of dysmenorrhea and the intensity of menstrual bleeding, overactive bladder symptom score, female bladder function (UDI-6 & IIQ-7), female sexual function index, and bowel incontinence assessment questionnaires. In addition, patients who underwent surgeries for myoma or adenomyosis will be requested to complete the above questionnaires and ultrasound examination at 3 months and 6 months after therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must be at least 18 years old.
  • Adenomyosis: There must be several dark areas on at least one side of the uterine wall; the uterine wall must be thickened; in addition, the thickened uterine wall must have a nonhomogeneous structure; and clinically, there must be dysmenorrhea or menorrhagia.

Exclusion criteria

  • The patient currently has an acute lower urinary tract infection or intestinal inflammation.
  • The patient has previously undergone bladder or urethral surgery.
  • The patient has a history of urinary tract stones or tumors.

Treatment and study plan

High Intensity Focused Ultrasound

Procedure

MRI guided High Intensity Focused Ultrasound

Primary outcomes

  1. Dysmenorrhea

    Time frame: 6 months

    The changes of VAS scores of dysmenorrhea

Secondary outcomes

  1. Menorrhagia

    Time frame: 6 months

    The change of VAS scores of menorrhagia

  2. Overactive bladder symptoms

    Time frame: 6 months

    The changes of Overactive Bladder Symptoms Scores

  3. Female sexual function

    Time frame: 6 months

    The changes of female sexual function index scores

  4. Bowel incontinence

    Time frame: 6 months

    The changes of the scores in the bowel incontience questtionnaires

  5. Overall condition of dysmenorrhea

    Time frame: 6 months

    The scores of Global response assessment in dysmenorreha after HIFU

  6. Overall condition in menorrhagia

    Time frame: 6 months

    Th scores of Global response assessment in menorrhagia after HIFU

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Acronym: HIFU

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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