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

Phase 4

Completed

• Conditions: Menorrhagia

• Registration Number: NCT01436903
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-09-18
• Study First Posted: 2011-09-20
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 290

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Landesklinikum Thermenregion Neunkirchen; 🇦🇹 Neunkirchen, Lower Austria, Austria