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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of High-Intensity Focused Ultrasound Therapy on Adenomyosis
- ClinicalTrials.gov ID
- NCT07808034
- Acronym / sponsor ID
- HIFU / 114309-E
- Conditions
- Adenomyosis of Uterus
- Keywords
- adenomyosis, lower urinary tract symptoms, sexual dysfunction, gastrointestinal symptoms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenomyosis | – | Procedure: High Intensity Focused Ultrasoundadenomyosis of the uterus |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic uterine adenomyosis:
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused UltrasoundMRI guided High Intensity Focused Ultrasound | Procedure or surgery | Adenomyosis |
Primary outcome
Dysmenorrhea
Time frame: 6 months
The changes of VAS scores of dysmenorrhea
6 secondary outcomes
Menorrhagia
Time frame: 6 months
Overactive bladder symptoms
Time frame: 6 months
Female sexual function
Time frame: 6 months
Bowel incontinence
Time frame: 6 months
Overall condition of dysmenorrhea
Time frame: 6 months
Overall condition in menorrhagia
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Adenomyosis of Uterus
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
RecruitingObservational study
Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine
Endometriosis, Adenomyosis of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis of Uterus, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysmenorrhea (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.