Sonographic Features of Fibroids Before and During Non-surgical Therapy and/or Expectant Management

NCT05741671 | Unknown DMC

• 1 other identifier: 2017.494
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: 20-30% of women of reproductive age have leiomyomas, causing symptoms like dysmenorrhea and pelvic pain which both effect quality of life.\[1-4\] The natural behaviour of uterine fibroids is to grow between 7 to 84% in 3 to 12 months.\[5-7\] Non-surgical options to treat uterine fibroids are non-hormonal or hormonal medical therapies and minimally invasive interventional radiologic techniques. Exogenous hormone exposure including COC, POP or Mirena give in conflicting literature minimal growth to 60% volume shrinkage. \[8, 9\]\] Selective progesterone receptor modulators (SPRM) eg. Esmya and GnRH-analogues intent to reduce fibroids volume after several months; GnRH-agonists provide a 31-63% shrinkage and less frequently applied GnRH-antagonists 14.3 - 42.7%.\[10-16\] Esmya gives a volume reduction varying between 10 to 48%.\[17\] Radiological technique like embolization decreases dominant fibroid volume with 40-70%.\[1, 18-22\] UAE fails in case of devascularized or minimal vascularized fibroids.\[23\] Ablation techniques show shrinkage up to a maximum of 90% depending e.g. which treatment.\[24-41\] Clear prognostic models to predict the effect on fibroid related symptoms and volume reduction are lacking. We postulate higher vascularity to be related to 1) larger fibroid growth during the natural course or during exogenous hormonal exposure; 2) more effective shrinkage during progestogens, GnRH-analogues, SPRM and UAE; but 3) less effective after ablation therapy. Objectives: To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRM or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy. Study design: Observational cohort study during 5 years in the outpatient clinic. Patientselection: Women ≥18 years with 1 to 3 fibroids with a maximal diameter ≥ 3cm and ≤ 10cm diagnosed on ultrasound examination, planned for expectant or non-surgical management. Study objectives: The primary outcome is volume reduction after 3 to 12 month depending on the study group. The secondary outcome include UFS-QOL, EQ-5D score, PBAC, hemoglobin level, treatment failure rate and (re)intervention rate. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risks are associated with the participation of this observational study since the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test. These measurements are also applied in daily practice, the burden for the patient is time. Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes. The treatment considering the fibroid(s) is independent of this research.

Conditions

Fibroid Uterus

Keywords

fibroid; power doppler; vascularization

Outcome Measures

Primary Outcomes (1)

• Volume change

  Three directions on 2D ultrasound in centimeters.

  Baseline, 3 and 12 months, in embolization and ablation group after 6 months

Secondary Outcomes (6)

• Questionnaire Utreine Fibroid Specific Quality of Life

  Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months

• Questionnaire EuroQol 5 Dimensions

  Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months

• Questionnaires Picterial Bloodloss Assessment Chart

  Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months

• Questionnaire re-intervention rate

  Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months

• Questionnaire treatment failure rate

  Baseline, 3, 12 and 24 months, in embolization and ablation group after 6 months

Study Arms (6)

natural course

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Natural behaviour - 1 year

Other: Questionnaire

during long-term use of exogenous hormone exposure

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Long-term exogenous hormonal exposure - 1 year

Other: Questionnaire

Selective progesterone receptor modulators treatment or GnRH-analogues treatment

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: SPRMs or GnRH-analogues - 3 months

Other: Questionnaire

after initiation exogenous hormonal exposure

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Initiation of exogenous hormonal exposure - 1 year

Other: Questionnaire

embolization therapy

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Embolization - 6 months

Other: Questionnaire

ablation therapy

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy . Primary outcome: Ablation therapy - 6 months

Other: Questionnaire

Interventions

Questionnaire OTHER

Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes. The treatment considering the fibroid(s) is independent of this research. the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test. These measurements are applied in daily practice, as standard care.

Selective progesterone receptor modulators treatment or GnRH-analogues treatment; ablation therapy; after initiation exogenous hormonal exposure; during long-term use of exogenous hormone exposure; embolization therapy; natural course

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Fibroids are uterine-related
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women pre- to perimenopausal with uterus myomatosis. Uterus myomatosis occurs in 20-30% of women of reproductive age.

You may qualify if:

• to 3 fibroids
• maximal diameter ≥1.5 cm and ≤ 10 cm
• diagnosed on ultrasound examination with informed consent
• planned for expectant management or non-surgical management in the follwing groups:
• Women with uterine fibroids without treatment (during natural course);
• Women with uterine fibroids using exogenous hormone exposure for at least 3 months: e.g. COC, POP, DP or LNG-IUD;
• Women with uterine fibroids before and after/during treatment with SPRMs or GnRH-analogues;
• Women with uterine fibroids before and after/during treatment with exogenous hormones;
• Women with uterine fibroids before and after embolization;
• Women with uterine fibroids before and after ablation therapy\*.

You may not qualify if:

• Any fibroid treatment in the last 3 months in case of (3) SPRMs or GnRH-analogues (except for exogenous hormone exposure) or (1) no treatment Age \< 18 years
• Fibroids not accessible for transvaginal ultrasonography
• Suspicion for malignancy
• Postmenopausal
• Severe adenomyosis
• Pregnancy
• Contra-indication for the planned treatment
• Use of aromatase inhibitors or tamoxifen Infertility treatment with use of clomifene and/or follicle-stimulating hormone Breastfeeding

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Neovascularization, Pathologic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Judith Huirne, Prof.

CONTACT

0031205664167; j.huirne@amsterdamumc.nl

Marjolein Spiering

CONTACT

0031205665625; m.spiering@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Reseach Office Womens Child Center

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 23, 2023
• Study Start: September 24, 2018
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)