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Not yet recruitingNCT07808034HIFUUpdated Sep 8, 2026

The Efficacy of High-Intensity Focused Ultrasound Therapy on Adenomyosis

An observational study in Adenomyosis of Uterus, sponsored by Far Eastern Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Far Eastern Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Adenomyosis of Uterus

Keywords

  • adenomyosis
  • lower urinary tract symptoms
  • sexual dysfunction
  • gastrointestinal symptoms
03

In context

Adenomyosis

142 studies on the registry are indexed under Adenomyosis; 54 are open to participants now.

This study's planned enrollment of 20 is below the median of 200 across 57 observational studies indexed under Adenomyosis.

Browse Adenomyosis studies →

Lead sponsor

Far Eastern Memorial Hospital is the lead sponsor of 260 studies on the registry; 40 are open to participants now.

Browse Far Eastern Memorial Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with symptomatic uterine adenomyosis:

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adenomyosis

    adenomyosis of the uterus

    Procedure: High Intensity Focused Ultrasound

Interventions

  • ProcedureHigh Intensity Focused Ultrasound

    MRI guided High Intensity Focused Ultrasound

06

What researchers measure

Primary outcomes

  1. Dysmenorrhea

    The changes of VAS scores of dysmenorrhea

    Time frame: 6 months

Secondary outcomes

  1. Menorrhagia

    The change of VAS scores of menorrhagia

    Time frame: 6 months

  2. Overactive bladder symptoms

    The changes of Overactive Bladder Symptoms Scores

    Time frame: 6 months

  3. Female sexual function

    The changes of female sexual function index scores

    Time frame: 6 months

  4. Bowel incontinence

    The changes of the scores in the bowel incontience questtionnaires

    Time frame: 6 months

  5. Overall condition of dysmenorrhea

    The scores of Global response assessment in dysmenorreha after HIFU

    Time frame: 6 months

  6. Overall condition in menorrhagia

    Th scores of Global response assessment in menorrhagia after HIFU

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.

Of 31 observational studies under Adenomyosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 29. This study's planned 27 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 8, 2026
StartEst.
Sep 16, 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07808034
Lead sponsor
Far Eastern Memorial Hospital
Responsible party
Sheng-Mou Hsiao, MD (Chief of Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 16, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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