Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length

Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients

CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.

Study Overview

• Status: Completed
• Conditions: Menorrhagia
• Intervention / Treatment: Device: Thermal Balloon Endometrial Ablation

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Lower Austria
    • Neunkirchen, Lower Austria, Austria, 2620
      • Landesklinikum Thermenregion Neunkirchen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• CavatermTM operation because of menorrhagia
• timeframe: January 2006 till August 2009
• older than 29 years and younger than 56 years

Exclusion Criteria:

• pregnancy
• fragmentary filled questionnaire
• more than 1 CavatermTM operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postsurgical change in bleeding patterns dependent on cavum probe length.	Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.	Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Postsurgical change in patient satisfaction dependent on cavum probe length.	The questionnaire will ask for satisfaction and recommendation to the best friend.	Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postsurgical change in dyspareunia	The questionnaire will ask for pre- and postsurgical dyspareunia.	A questionnaire will be sent in September 2010, at least after one postsurgical year.
Postsurgical change in Premenstrual Syndrome	The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.	A questionnaire will be sent in September 2010, at least after one postsurgical year.
Prevention of further gynaecological therapies	The questionnaire will ask for postsurgical hysterectomy and further medications.	A questionnaire will be sent in September 2010, at least after one postsurgical year.
Improvement of quality of life	The questionnaire will ask for postsurgical quality of life.	A questionnaire will be sent in September 2010, at least after one postsurgical year.

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Beda W. Hartmann, Univ.-Doz., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: September 18, 2011
• First Posted (Estimate): September 20, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: March 7, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: menorrhagia; endometrial ablation; probe; dysfunctional uterine bleeding; cavatermTM
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia
• Other Study ID Numbers: 743/2010