Sexual DysfunctionNCT04764578
Sexual Dysfunction Following Upper Extremity Trauma
An observational study of Sexual Dysfunction and Upper Extremity Trauma, run by Vanderbilt University Medical Center.
Trial summary
Hypothesis 1. The prevalence of sexual dysfunction after upper extremity function in adults (>18yo) is higher than the general population in the early post-operative period (3mo) and at 1 year post-operatively. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Dysfunction, Upper Extremity Trauma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 26 Oct 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Potential study participants will be identified when they present to Vanderbilt University Medical Center or Vanderbilt Department of Orthopaedic Clinics for follow up for their isolated upper extremity trauma.
Who may be able to join
- All adult patients > 18 years old with an isolated upper extremity injury treated operatively or non-operatively at Vanderbilt University Medical Center
- Isolated upper extremity is defined as:
- Fractures, stratified by level
- Hand (phalanx, metacarpal), wrist (carpal, distal radius), forearm (radial shaft, ulnar shaft, both bone), elbow (distal humerus, proximal ulna, radial head), arm (humeral shaft), shoulder (proximal humerus, scapula, clavicle)
- Soft tissue trauma involving ligament or muscle injury requiring repair or soft tissue defect requiring flap coverage
- Nerve injury, stratified by level
Show all 10Show fewer
- Peripheral nerve injury vs plexus injury
- Vascular injury
- Amputation
- Combined injury
Who cannot join
- Age < 18 at time of injury
- Traumatic brain injury
- Other concomitant orthopaedic injury to the lower extremities
- Other trauma requiring hospital admission (abdominopelvic, thoracic, head or spine trauma)
- Patients with bilateral upper extremity injuries
About this study
Hypothesis
- The prevalence of sexual dysfunction after upper extremity function in adults (>18yo) is higher than the general population in the early post-operative period (3mo) and at 1 year post-operatively.
- Null: Adult patients (<18 yo) with isolated upper extremity trauma do not experience sexual dysfunction more than the general population.
Read more
Primary Study Question
- What is the prevalence of sexual dysfunction after upper extremity trauma (fracture, soft tissue disruption, neurovascular injury, and completion amputation) in adult patients?
Secondary Study Questions
- Are there patient or injury factors that can predict sexual dysfunction?
- Do certain fractures cause more sexual dysfunction than others?
- Can we accurately predict which patients may experience sexual dysfunction post-injury?
Read the detailed description
Enrollment Visit Following the consent process, patient demographics, injury information, and baseline pre-trauma sexual function will be documented as part of the patient's baseline assessment. Participants will be asked to complete the study survey which will combine 1 question (Item 21 Sexual Dysfunction) from the Disabilities of Arm, Shoulder and Hand (DASH) and the 5 question, Likert-like, Arizona Sexual Experience Scale (ASEX)7,8 . Depending on the participant's response to survey item 1, they may or may not be asked to complete the remaining 5 questions. As part of routine care in the Department of Orthopaedics, patients being seen in the Hand \& Upper Extremity outpatient clinics are asked to complete the following surveys: QuickDASH, SANE, PROMIS Physical Function CAT and PROMIS Anxiety CAT. The study will access/utilize the responses to these routine care patient reported outcomes to correlate to our study survey responses. This routine care PRO data will be stored in the electronic health record. Project team members listed as Key Study Personnel with existing electronic health record (EHR) system access rights may be granted use of REDCap Clinical Data Interoperability Services (CDIS) tools. These tools are designed to enable transfer of relevant study-related data from the Vanderbilt Research Derivative and/or directly from the EHR into REDCap. If KSP are unable to transfer data using CDIS, it will be manually entered into the REDCap database. If, for some reason, the participant does not complete the routine care PROs at their enrollment visit, we will ask them to complete the surveys as part of the study.
Follow-up Visits Participants will be asked to complete the same study survey at their 3 month, 6 month and 12 month follow-up visits. The study will access/utilize the routine care PRO responses (QuickDASH, SANE, PROMIS Physical Function CAT and PROMIS Anxiety CAT) at these visits, also. If, for some reason, the participant does not complete the routine care PROs at their follow-up visit, we will ask them to complete the surveys as part of the study.
If the participant does not have a routine care appointment scheduled at the follow-up visit time points, misses a routine care follow-up appointment or the study staff are not available to collect data at these follow-up appointments, the research coordinator will attempt to contact the patient by phone, mail or electronically using REDCap, to obtain the outcomes data.
- Conditions
- Sexual Dysfunction, Upper Extremity Trauma
- Medical subject headings
- Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (Item 21 Sexual Dysfunction) Score
The DASH item response ranges from 1 (no difficulty) to 5 (unable).
21 Item Sexual Dysfunction from the Disabilities of Arm, Shoulder and Hand (DASH)
Measured: Change between baseline, 3-month, 6-month, and 12-month visits.
Arizona Sexual Experience Scale (ASEX) Score
The Arizona Sexual Experience Scale (ASEX) is a 5 item Likert-like scale with response ranges from 1 (extremely easily) to 6 (never).
Measured: Change between baseline, 3-month, 6-month, and 12-month visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2022
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Why it stopped: Staffing shortages
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jed Maslow, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764578
- Sponsor's protocol ID
- 210352
- Status last verified
- Nov 2022
- First submitted
- 18 Feb 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction Following Upper Extremity Trauma
- ClinicalTrials.gov ID
- NCT04764578
- Acronym / sponsor ID
- 210352
- Conditions
- Sexual Dysfunction, Upper Extremity Trauma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Staffing shortages
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- 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.
Hypothesis
- The prevalence of sexual dysfunction after upper extremity function in adults (>18yo) is higher than the general population in the early post-operative period (3mo) and at 1 year post-operatively.
- Null: Adult patients (<18 yo) with isolated upper extremity trauma do not experience sexual dysfunction more than the general population.
Primary Study Question
- What is the prevalence of sexual dysfunction after upper extremity trauma (fracture, soft tissue disruption, neurovascular injury, and completion amputation) in adult patients?
Secondary Study Questions
- Are there patient or injury factors that can predict sexual dysfunction?
- Do certain fractures cause more sexual dysfunction than others?
- Can we accurately predict which patients may experience sexual dysfunction post-injury?
Detailed description
Enrollment Visit Following the consent process, patient demographics, injury information, and baseline pre-trauma sexual function will be documented as part of the patient's baseline assessment. Participants will be asked to complete the study survey which will combine 1 question (Item 21 Sexual Dysfunction) from the Disabilities of Arm, Shoulder and Hand (DASH) and the 5 question, Likert-like, Arizona Sexual Experience Scale (ASEX)7,8 . Depending on the participant's response to survey item 1, they may or may not be asked to complete the remaining 5 questions. As part of routine care in the Department of Orthopaedics, patients being seen in the Hand \& Upper Extremity outpatient clinics are asked to complete the following surveys: QuickDASH, SANE, PROMIS Physical Function CAT and PROMIS Anxiety CAT. The study will access/utilize the responses to these routine care patient reported outcomes to correlate to our study survey responses. This routine care PRO data will be stored in the electronic health record. Project team members listed as Key Study Personnel with existing electronic health record (EHR) system access rights may be granted use of REDCap Clinical Data Interoperability Services (CDIS) tools. These tools are designed to enable transfer of relevant study-related data from the Vanderbilt Research Derivative and/or directly from the EHR into REDCap. If KSP are unable to transfer data using CDIS, it will be manually entered into the REDCap database. If, for some reason, the participant does not complete the routine care PROs at their enrollment visit, we will ask them to complete the surveys as part of the study.
Follow-up Visits Participants will be asked to complete the same study survey at their 3 month, 6 month and 12 month follow-up visits. The study will access/utilize the routine care PRO responses (QuickDASH, SANE, PROMIS Physical Function CAT and PROMIS Anxiety CAT) at these visits, also. If, for some reason, the participant does not complete the routine care PROs at their follow-up visit, we will ask them to complete the surveys as part of the study.
If the participant does not have a routine care appointment scheduled at the follow-up visit time points, misses a routine care follow-up appointment or the study staff are not available to collect data at these follow-up appointments, the research coordinator will attempt to contact the patient by phone, mail or electronically using REDCap, to obtain the outcomes data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Potential study participants will be identified when they present to Vanderbilt University Medical Center or Vanderbilt Department of Orthopaedic Clinics for follow up for their isolated upper extremity trauma.
Key inclusion criteria (10 listed)
- All adult patients > 18 years old with an isolated upper extremity injury treated operatively or non-operatively at Vanderbilt University Medical Center
- Isolated upper extremity is defined as:
- Fractures, stratified by level
- Hand (phalanx, metacarpal), wrist (carpal, distal radius), forearm (radial shaft, ulnar shaft, both bone), elbow (distal humerus, proximal ulna, radial head), arm (humeral shaft), shoulder (proximal humerus, scapula, clavicle)
- Soft tissue trauma involving ligament or muscle injury requiring repair or soft tissue defect requiring flap coverage
Key exclusion criteria (5 listed)
- Age < 18 at time of injury
- Traumatic brain injury
- Other concomitant orthopaedic injury to the lower extremities
- Other trauma requiring hospital admission (abdominopelvic, thoracic, head or spine trauma)
- Patients with bilateral upper extremity injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disabilities of the Arm, Shoulder and Hand (Item 21 Sexual Dysfunction) Score
Time frame: Change between baseline, 3-month, 6-month, and 12-month visits.
The DASH item response ranges from 1 (no difficulty) to 5 (unable). 21 Item Sexual Dysfunction from the Disabilities of Arm, Shoulder and Hand (DASH)
Arizona Sexual Experience Scale (ASEX) Score
Time frame: Change between baseline, 3-month, 6-month, and 12-month visits.
The Arizona Sexual Experience Scale (ASEX) is a 5 item Likert-like scale with response ranges from 1 (extremely easily) to 6 (never).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction and Upper Extremity Trauma, run by Vanderbilt University Medical Center.
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 10 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Nov 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Disabilities of the Arm, Shoulder and Hand (Item 21 Sexual Dysfunction) Score (time frame: Change between baseline, 3-month, 6-month, and 12-month visits.). 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 8 Nov 2022.