Catheter Placement and Perceived PainNCT00534963
Optimal Catheter Placement During Sonohysterography: Comparison of Cervical to Uterine Placement
A study testing cervical vs. uterine placement of balloon catheter in people with Catheter Placement and Perceived Pain, run by University of Wisconsin, Madison.
Trial summary
The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Catheter Placement and Perceived Pain
- What is being tested?
- cervical vs. uterine placement of balloon catheter
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Aug 2005
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female patients undergoing SIS for diagnostic uterine cavity evaluation at our university's Reproductive Endocrine Infertility Program.
Who cannot join
- previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.
About this study
Official title: Optimal Catheter Placement During Sonohysterography: A Randomized Clinical Trial Comparing Cervical to Uterine Placement
The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.
Read the detailed description
The use of sonography combined with intrauterine saline instillation, termed sonohysterography
- Conditions
- Catheter Placement and Perceived Pain
- Being tested
- cervical vs. uterine placement of balloon catheter
- Keywords
- sonohysterography, catheter placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical vs. uterine placement of balloon catheterProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: perceived discomfort
Measured: during sonohysterography procedure
Secondary outcomes (1)
Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure
Measured: during sonohysterography procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startDec 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter Placement and Perceived PainStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Lindheim, MD, Principal investigator, University of Wisconsin Department of Reproductive Endocrinology and Infertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534963
- Sponsor's protocol ID
- H-2004-0066
- Status last verified
- Oct 2017
- First submitted
- 23 Sep 2007
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spieldoch RL, Winter TC, Schouweiler C, Ansay S, Evans MD, Lindheim SR. Optimal catheter placement during sonohysterography: a randomized controlled trial comparing cervical to uterine placement. Obstet Gynecol. 2008 Jan;111(1):15-21. doi: 10.1097/01.AOG.0000295865.93719.3f.
PubMed 18165388
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Catheter Placement During Sonohysterography: A Randomized Clinical Trial Comparing Cervical to Uterine Placement
- ClinicalTrials.gov ID
- NCT00534963
- Acronym / sponsor ID
- H-2004-0066
- Conditions
- Catheter Placement and Perceived Pain
- Keywords
- sonohysterography, catheter placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 26 Sep 2007 (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.
The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.
Detailed description
The use of sonography combined with intrauterine saline instillation, termed sonohysterography
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients undergoing SIS for diagnostic uterine cavity evaluation at our university's Reproductive Endocrine Infertility Program.
Key exclusion criteria (1 listed)
- previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.
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 |
|---|---|---|
| cervical vs. uterine placement of balloon catheter | Procedure or surgery | – |
Primary outcome
Measure: perceived discomfort
Time frame: during sonohysterography procedure
1 secondary outcome
Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure
Time frame: during sonohysterography procedure
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 26 Oct 2017.
- Derived from this study: PubMed 18165388Spieldoch RL, Winter TC, Schouweiler C, Ansay S, Evans MD, Lindheim SR. Optimal catheter placement during sonohysterography: a randomized controlled trial comparing cervical to uterine placement. Obstet Gynecol. 2008 Jan;111(1):15-21. doi: 10.1097/01.AOG.0000295865.93719.3f.
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.
Steven Lindheim, MD principal investigator
University of Wisconsin Department of Reproductive Endocrinology and Infertility
Questions about this trial
What is this clinical trial studying?
A study testing cervical vs. uterine placement of balloon catheter in people with Catheter Placement and Perceived Pain, run by University of Wisconsin, Madison.
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 1 inclusion and 1 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Measure: perceived discomfort (time frame: during sonohysterography procedure). 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 NCT00534963, which also lists 1 linked publication.
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 26 Oct 2017.