MenorrhagiaNCT01848847

Relationship Between Bladder Distention and Hysteroscopy Application

A study testing Hysteroscopy in people with Menorrhagia, run by Namik Kemal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure. Read more about this study

Who is it for?: Ages 17 to 55 years, women only
Conditions the study is for: Menorrhagia
What is being tested?: Hysteroscopy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Apr 2013to Jul 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 to 55 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

Women who are at reproductive age
Women who are not pregnant at the time of presentation
Women who are not nulliparous

Who cannot join

Women who have previous cervical surgery or cervical incompetence.
Women who have genitourinary infection
Women who have profuse uterine bleeding or recent uterine perforation
Women who have neurological disorders affecting evaluation of pain.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology
Tekirdağ, 59100

Other trials in Turkey (Türkiye)

About this study

Official title: The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.

The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.

Read the detailed description

Women who should have diagnostic hysteroscopy procedure will be randomly allocated into two groups. In the first group hysteroscopy will be performed with a filled bladder and in the second group procedure will be performed with an empty bladder. The women will be assigned into groups randomly. The duration of the procedure, feasibility of the procedure and tolerability of procedure will be recorded.

Conditions: Menorrhagia
Being tested: Hysteroscopy
Keywords: Hysteroscopy, Bladder, Pain, Feasibility, Duration
Medical subject headings: Menorrhagia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HysteroscopyProcedure or surgery

Study groups in NCT01848847
Study group	Role	What they receive
Full Bladder	Experimental	Hysteroscopy conducted under full bladder. Receives: Procedure: Hysteroscopy
Empty Bladder	Experimental	Hysteroscopy conducted under empty bladder. Receives: Procedure: Hysteroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Ease of Cervical Entry
Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.
Measured: 2 months
Pain Scoring(VAS)
Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number
Measured: 2 months

Secondary outcomes (2)

Patient Acceptability and Pain Scoring
Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
Measured: two months
Procedure Duration
Procedural time which will be measured in minutes
Measured: two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Jul 2013

First posted8 May 2013 (estimated)
Study startApr 2013
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for MenorrhagiaStudies 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 N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01848847
Sponsor's protocol ID: 9598
Status last verified: Jul 2013
First submitted: 10 Apr 2013
Last updated: 16 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kabli N, Tulandi T. A randomized trial of outpatient hysteroscopy with and without intrauterine anesthesia. J Minim Invasive Gynecol. 2008 May-Jun;15(3):308-10. doi: 10.1016/j.jmig.2008.01.013. Epub 2008 Mar 20.
PubMed 18439502
Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.
PubMed 22387163
De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
PubMed 10648742
Pansky M, Feingold M, Bahar R, Neeman O, Asiag O, Herman A, Sagiv R. Improved patient compliance using pediatric cystoscope during office hysteroscopy. J Am Assoc Gynecol Laparosc. 2004 May;11(2):262-4. doi: 10.1016/s1074-3804(05)60211-3.
PubMed 15200787

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 3
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Von Willebrand Diseases
Not yet recruitingObservational study
Heavy Menstrual Bleeding and Dysmenorrhea Among Undergraduate Females in the Faculty of Medicine of Assiut University
Dysmenorrhea, Heavy Menstrual Bleeding

All Menorrhagia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.
ClinicalTrials.gov ID: NCT01848847
Acronym / sponsor ID: 9598
Conditions: Menorrhagia
Keywords: Hysteroscopy, Bladder, Pain, Feasibility, Duration
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Namik Kemal UniversityUniversity, hospital or other
Study start: Apr 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 8 May 2013 (estimated)
Results: Posted 16 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Full Bladder	Experimental	Procedure: HysteroscopyHysteroscopy conducted under full bladder.
Empty Bladder	Experimental	Procedure: HysteroscopyHysteroscopy conducted under empty bladder.

Who may qualify

Ages: 17 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Women who are at reproductive age
Women who are not pregnant at the time of presentation
Women who are not nulliparous

Key exclusion criteria (4 listed)

Women who have previous cervical surgery or cervical incompetence.
Women who have genitourinary infection
Women who have profuse uterine bleeding or recent uterine perforation
Women who have neurological disorders affecting evaluation of pain.

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
Hysteroscopy	Procedure or surgery	Empty Bladder, Full Bladder

Primary outcome

Ease of Cervical Entry
Time frame: 2 months
Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.
Pain Scoring(VAS)
Time frame: 2 months
Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number

2 secondary outcomes

Patient Acceptability and Pain Scoring
Time frame: two months
Procedure Duration
Time frame: two months

Results and safety

Results posted to the registry on 16 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empty Bladder	51	49
Full Bladder	51	48

Primary outcome: Ease of Cervical Entry

Time frame: 2 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Empty Bladder n = 49	Full Bladder n = 48
Value	4.00 (0.86)	3.55 (0.90)

Primary outcome: Pain Scoring(VAS)

Time frame: 2 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Empty Bladder n = 49	Full Bladder n = 48
Value	2.52 (1.2)	1.95 (1.1)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empty Bladder	0 of 49 (0%)	0 of 49 (0%)	Not reported
Full Bladder	0 of 47 (0%)	0 of 47 (0%)	Not reported

Limitations and caveats (from the sponsor): difficulties in introduction of hysteroscopy

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18439502Kabli N, Tulandi T. A randomized trial of outpatient hysteroscopy with and without intrauterine anesthesia. J Minim Invasive Gynecol. 2008 May-Jun;15(3):308-10. doi: 10.1016/j.jmig.2008.01.013. Epub 2008 Mar 20.
Background: PubMed 22387163Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.
Background: PubMed 10648742De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
Background: PubMed 15200787Pansky M, Feingold M, Bahar R, Neeman O, Asiag O, Herman A, Sagiv R. Improved patient compliance using pediatric cystoscope during office hysteroscopy. J Am Assoc Gynecol Laparosc. 2004 May;11(2):262-4. doi: 10.1016/s1074-3804(05)60211-3.

Related trials for Menorrhagia

RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 3
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Von Willebrand Diseases
Not yet recruitingObservational study
Heavy Menstrual Bleeding and Dysmenorrhea Among Undergraduate Females in the Faculty of Medicine of Assiut University
Dysmenorrhea, Heavy Menstrual Bleeding

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.

Cem Celik, Assist Prof study director

Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hysteroscopy in people with Menorrhagia, run by Namik Kemal University at 1 site in Turkey (Türkiye).

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 3 inclusion and 4 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 16 Dec 2013. 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 Turkey (Türkiye). 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ease of Cervical Entry (time frame: 2 months). 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?

On the ClinicalTrials.gov record for NCT01848847, which also lists 4 linked publications.

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 16 Dec 2013.