Dysfunction Uterine BleedingPhase 2TEANCT02248194
Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
A Phase 2 study testing Tactile electrosurgical ablation probe and Hysteroscopic endometrial ablation in people with Dysfunction Uterine Bleeding, run by Mostafa Hussein at 1 site in Egypt.
Trial summary
Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood flow and heavy menstrual bleeding affects up to 30% of women at some time during their reproductive years. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Dysfunction Uterine Bleeding
- What is being tested?
- Tactile electrosurgical ablation probe and Hysteroscopic endometrial ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with dysfunctional uterine bleeding aged between 40 to 50 years
- Unsuccessful medical treatment.
- No intrauterine abnormalities.
- Endometrial biopsy negative for atypia and cancer.
- follicle stimulating hormone level not exceeds 30 mills-International unit
- Family complete
- Patients who are not candidate for hysterectomy because of medical or surgical risks.
Who cannot join
- Coexisting gynecological pathology (e.g. uterovaginal prolapsed, ovarian pathology, pelvic inflammatory disease, cervical atypia).
- Endometrial hyperplasia with atypia and cancer..
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Uterine size more than 12 weeks in size.
- Women with caesarean or myomectomy scar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood flow and heavy menstrual bleeding affects up to 30% of women at some time during their reproductive years. Abnormal menstruation can be due to conditions such as pregnancy complication uterine fibroids and adenomyosis, but in a large proportion of cases, the etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding (DUB). Treatment options for DUB include symptomatic medical treatment or surgery, traditionally hysterectomy.
Hysteroscopically guided endometrial ablation methods have been shown to be effective and safe alternatives to hysterectomy for management of DUB. These methods require particular skills and experience and a long learning curve to be performed effectively and safely.
Read more
Through the past three decades DUB patients in Assiut university hospital were treated with either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges during transcervical resection of the endometrium or rollerball coagulation, we used to shift to thermal balloon as backup method . However, expensive uterine balloon could not infrequently be afforded because of financial constrains and limited health resources . Therefore, another method was used as backup for hysteroscopic failures. It was first tried via insulating the conventional double-ended uterine curette then through a specially designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely similar to the dilatation and curettage procedure both principally and practically. Hence, the basic requirements for its performance are the general awareness with electrosurgical principles and adequate experience in performing dilatation and curettage. TEA is done by specially designed tactile diathermy probe that carried the job of electrosurgical ablation without hysteroscopy or distension media first in an experimental session that clearly clarified the reproducibility of the depth of thermal damage and safety of the tactile electrosurgical ablator . Thereafter, TEA was successfully performed with satisfactory short and medium term outcomes for ten cases with DUB during an active, relentless bleeding attack. TEA is done under laparoscopic monitoring.
The aim of the present work is to present TEA as a simple, inexpensive, novel backup approach for treatment of DUB.
- Conditions
- Dysfunction Uterine Bleeding
- Being tested
- Tactile electrosurgical ablation probe, Hysteroscopic endometrial ablation
- Keywords
- Dysfunction uterine bleeding, Hysteroscopic endometrial ablation, Tactile endometrial ablation, Hysteroscopic difficulties, Quality of life, Satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile electrosurgical ablation probeDevice
Hysteroscopic endometrial ablationDevice
Also called Transcervical resection of the endometrium
| Study group | Role | What they receive |
|---|---|---|
| Group 1"Tactile electrosurgical ablation" | Experimental | Endometrial ablation will be done by Tactile electrosurgical ablation probe. Receives: Device: Hysteroscopic endometrial ablation |
| Group 2 "Hysteroscopic endometrial ablation" | Active comparator | Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium. Receives: Device: Tactile electrosurgical ablation probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the treatment at 12 month follow up
Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.
Measured: 12 moth
Change in menstrual status.
Menstrual status will be reported as
- Normal menstrual flow.
- Light menstrual bleeding.
- Heavy menstrual bleeding.
- The need for hysterectomy.
Measured: At 3, 6, 9, and12 months pot operatve.
Secondary outcomes (9)
Acceptability of treatment
Acceptability of the procedure will be assessed in 3- point scale as cure or acceptable improvement in symptoms, treatment acceptable and would recommend treatment to others or not acceptable
Measured: 4 weeks
Changes in health related quality of life
Health-related quality of life parameters will be completed using
- Short form-12 (SF12).
- Life style questionnaires including Work affection will be measured by the number of days absence from the work due to menses as following, non ,non but work suffer, 1 day and >2 days.
- sexual life affection will be measured in two point as no or yes.
Measured: At 3, 6, 9, and 12 months post operative.
Difference in operative time between the two groups in minutes.
Difference in operative time is calculated using a stop watch.The zero minute is the time of starting the procedure. The stop watch is on at the zero minute then sopped at the end of the procedure.time of anesthesia is not included.
Measured: 0-60 minutes
Reporting of any intro-operative complications.
Intro-operative complications includes
- Cervical laceration.
- Perforation of the uterus.
- Hemorrhage
- Fluid overload.
Measured: 0-60 minutes.
Reporting of any technical complications.
Technical complications for transcervical resection of the endometrium (TCRE) includes
- Poor uterine distention.
- Slow clearance of the debris.
- Inefficient cutting.
- Poor visualization.
- problem of diathermy.
- Problems with the camera.
- problems with light source.
Technical complications for tactile electrosurgical ablation (TEA) includes
- Insulation problem.
- Connection problem.
- Inefficient diathermy power.
Measured: 0-60 minutes
Difference in post-operative pain score using visual analogue scale between the two groups.
Difference in post-operative pain score using visual analogue scale from 1-10.
Measured: 4 hours.
Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.
Measured: 28 days post operative
Length of hospital stay in days
Length of hospital stay in days is calculated from the day of operation till day of discharge.
Measured: up to 2 days
Difference in the cost of the two surgical procedure.
Direct cost of the surgical procedure itself is calculated.The cost of the TCRE procedure will include the cost paid for the hysteroscopic unit and the cost of glycine used as distension media.The cost of the TEA procedure will include the cost of laparoscopy, the cost of TEA probe, and the cost of diagnostic hysteroscopy. The cost of the investigations, anesthesia, pre and post operative treatments will be excluded from analysis as they are the same for both groups.
Measured: up to one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startApr 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunction Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Hussein
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Mostafa Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248194
- Sponsor's protocol ID
- Tactile ablation
- Acronym
- TEA
- Status last verified
- Dec 2015
- First submitted
- 22 Jan 2014
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
- ClinicalTrials.gov ID
- NCT02248194
- Acronym / sponsor ID
- TEA / Tactile ablation
- Conditions
- Dysfunction Uterine Bleeding
- Keywords
- Dysfunction uterine bleeding, Hysteroscopic endometrial ablation, Tactile endometrial ablation, Hysteroscopic difficulties, Quality of life, Satisfaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Mostafa HusseinUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Apr 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood flow and heavy menstrual bleeding affects up to 30% of women at some time during their reproductive years. Abnormal menstruation can be due to conditions such as pregnancy complication uterine fibroids and adenomyosis, but in a large proportion of cases, the etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding (DUB). Treatment options for DUB include symptomatic medical treatment or surgery, traditionally hysterectomy.
Hysteroscopically guided endometrial ablation methods have been shown to be effective and safe alternatives to hysterectomy for management of DUB. These methods require particular skills and experience and a long learning curve to be performed effectively and safely.
Through the past three decades DUB patients in Assiut university hospital were treated with either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges during transcervical resection of the endometrium or rollerball coagulation, we used to shift to thermal balloon as backup method . However, expensive uterine balloon could not infrequently be afforded because of financial constrains and limited health resources . Therefore, another method was used as backup for hysteroscopic failures. It was first tried via insulating the conventional double-ended uterine curette then through a specially designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely similar to the dilatation and curettage procedure both principally and practically. Hence, the basic requirements for its performance are the general awareness with electrosurgical principles and adequate experience in performing dilatation and curettage. TEA is done by specially designed tactile diathermy probe that carried the job of electrosurgical ablation without hysteroscopy or distension media first in an experimental session that clearly clarified the reproducibility of the depth of thermal damage and safety of the tactile electrosurgical ablator . Thereafter, TEA was successfully performed with satisfactory short and medium term outcomes for ten cases with DUB during an active, relentless bleeding attack. TEA is done under laparoscopic monitoring.
The aim of the present work is to present TEA as a simple, inexpensive, novel backup approach for treatment of DUB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1"Tactile electrosurgical ablation" | Experimental | Device: Hysteroscopic endometrial ablationEndometrial ablation will be done by Tactile electrosurgical ablation probe. |
| Group 2 "Hysteroscopic endometrial ablation" | Active comparator | Device: Tactile electrosurgical ablation probeHysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with dysfunctional uterine bleeding aged between 40 to 50 years
- Unsuccessful medical treatment.
- No intrauterine abnormalities.
- Endometrial biopsy negative for atypia and cancer.
- follicle stimulating hormone level not exceeds 30 mills-International unit
Key exclusion criteria (6 listed)
- Coexisting gynecological pathology (e.g. uterovaginal prolapsed, ovarian pathology, pelvic inflammatory disease, cervical atypia).
- Endometrial hyperplasia with atypia and cancer..
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Uterine size more than 12 weeks in size.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile electrosurgical ablation probe | Device | Group 2 "Hysteroscopic endometrial ablation" |
| Hysteroscopic endometrial ablationAlso: Transcervical resection of the endometrium | Device | Group 1"Tactile electrosurgical ablation" |
Primary outcome
Satisfaction with the treatment at 12 month follow up
Time frame: 12 moth
Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.
Change in menstrual status.
Time frame: At 3, 6, 9, and12 months pot operatve.
Menstrual status will be reported as * Normal menstrual flow. * Light menstrual bleeding. * Heavy menstrual bleeding. * The need for hysterectomy.
9 secondary outcomes
Acceptability of treatment
Time frame: 4 weeks
Changes in health related quality of life
Time frame: At 3, 6, 9, and 12 months post operative.
Difference in operative time between the two groups in minutes.
Time frame: 0-60 minutes
Reporting of any intro-operative complications.
Time frame: 0-60 minutes.
Reporting of any technical complications.
Time frame: 0-60 minutes
Difference in post-operative pain score using visual analogue scale between the two groups.
Time frame: 4 hours.
Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.
Time frame: 28 days post operative
Length of hospital stay in days
Time frame: up to 2 days
Difference in the cost of the two surgical procedure.
Time frame: up to one hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tactile electrosurgical ablation probe and Hysteroscopic endometrial ablation in people with Dysfunction Uterine Bleeding, run by Mostafa Hussein at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the treatment at 12 month follow up (time frame: 12 moth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.