Adenomyosis of UterusHIFUNCT07808034
The Efficacy of High-Intensity Focused Ultrasound Therapy on Adenomyosis
An observational study of Adenomyosis of Uterus, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To assess the efficacy of High-Intensity Focused Ultrasound on adenomyosis Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adenomyosis of Uterus
- What is being tested?
- High Intensity Focused Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2026to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic uterine adenomyosis:
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
To assess the efficacy of High-Intensity Focused Ultrasound on adenomyosis
Read the 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.
- Conditions
- Adenomyosis of Uterus
- Being tested
- High Intensity Focused Ultrasound
- Keywords
- adenomyosis, lower urinary tract symptoms, sexual dysfunction, gastrointestinal symptoms
- Medical subject headings
- Adenomyosis, Lower Urinary Tract Symptoms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused UltrasoundProcedure or surgery
MRI guided High Intensity Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Adenomyosis | adenomyosis of the uterus Receives: Procedure: High Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysmenorrhea
The changes of VAS scores of dysmenorrhea
Measured: 6 months
Secondary outcomes (6)
Menorrhagia
The change of VAS scores of menorrhagia
Measured: 6 months
Overactive bladder symptoms
The changes of Overactive Bladder Symptoms Scores
Measured: 6 months
Female sexual function
The changes of female sexual function index scores
Measured: 6 months
Bowel incontinence
The changes of the scores in the bowel incontience questtionnaires
Measured: 6 months
Overall condition of dysmenorrhea
The scores of Global response assessment in dysmenorreha after HIFU
Measured: 6 months
Overall condition in menorrhagia
Th scores of Global response assessment in menorrhagia after HIFU
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start16 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomyosis of UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, MD, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808034
- Sponsor's protocol ID
- 114309-E
- Acronym
- HIFU
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided