Endometrial tissue ablation: a clinical trial

Completed

Conditions: Dysfunctional uterine bleeding
Urological and Genital Diseases
Menorrhagia

Registration Number: ISRCTN23845359

Lead Sponsor: Maxima Medisch Centrum (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

1. Refractory menorrhagia with no definable organic cause (dysfunctional uterine bleeding).
2. Age over 25 years old
3. Uterine sound measurement of 6.0 - 12 cm (external os to internal fundus).
4. Failed, contraindicated or intolerance to conservative (medical) therapy.
5. Menstrual Diary:
A minimum PBLAC score of > 150 for 1 month. Intracavitary pathology, such as type 2 fibromas and small polyps (= 2cm), confirmed by hysteroscopy or Saline Infused Sonography (SIS)

Exclusion Criteria

1. Presence of bacteremia, sepsis, or other active systemic infection
2. Active or recurrent chronic pelvic inflammatory disease
3. Patients with documented coagulopathies
4. Symptomatic endometriosis
5. Prior uterine surgery (except low segment cesarean section) which interrupts the integrity of the uterine wall e.g.transmural myomectomy or classical cesarean section. Prior endometrial ablations.
6. Patients on medications that could thin the myometrial muscle, such as long-term steroid use.
7. Patients on anticoagulants.
8. Desire to have children or to preserve fertility
9. Patients currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
10. Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) or HSG. Specifically: Septate or bicornuate uterus or other congenital malformation of the uterine cavity.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients satisfaction:<br>At each follow up visit/telephone call patients satisfaction was noted. Patients can express their level satisfaction by using - completely satisfied, satisfied, doubtful satisfied or not satisfied.<br>It is also noted if any kind of reintervention is performed, such as the use of oral contraceptives or surgery.

Secondary Outcome Measures

Name	Time	Method
1. Quality of life: all patients are asked to complete quality of life questionnaires at baseline, at two days, six weeks, three months, six months and twelve months after surgery. We evaluate quality of life with the medical outcomes study SF 36, the Rotterdam symptom checklist and a structured clinical history questionnaire.<br>2. Amennorhoea: at each follow up visit/ telephone call duration of menstruation, dysmennorhoea and presence of clots are registered. Patients also complete a pictorial chart.