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The Efficacy of High-Intensity Focused Ultrasound Therapy on Adenomyosis

The Efficacy of High-Intensity Focused Ultrasound Therapy on Adenomyosis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07808034
Acronym
HIFU
Enrollment
20
Registered
2026-09-08
Start date
2026-09-16
Completion date
2028-12-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis of Uterus

Keywords

adenomyosis, lower urinary tract symptoms, sexual dysfunction, gastrointestinal symptoms

Brief summary

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

Detailed description

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.

Interventions

MRI guided High Intensity Focused Ultrasound

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. The patient must be at least 18 years old. 2. 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

1. The patient currently has an acute lower urinary tract infection or intestinal inflammation. 2. The patient has previously undergone bladder or urethral surgery. 3. The patient has a history of urinary tract stones or tumors.

Design outcomes

Primary

MeasureTime frameDescription
Dysmenorrhea6 monthsThe changes of VAS scores of dysmenorrhea

Secondary

MeasureTime frameDescription
Overall condition of dysmenorrhea6 monthsThe scores of Global response assessment in dysmenorreha after HIFU
Overall condition in menorrhagia6 monthsTh scores of Global response assessment in menorrhagia after HIFU
Bowel incontinence6 monthsThe changes of the scores in the bowel incontience questtionnaires
Menorrhagia6 monthsThe change of VAS scores of menorrhagia
Overactive bladder symptoms6 monthsThe changes of Overactive Bladder Symptoms Scores
Female sexual function6 monthsThe changes of female sexual function index scores

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026