An interventional study of Interpretation Modality: In Person and Interpretation Modality: Telephonic in Pelvic Floor Disorders, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Health services research
Among 61 studies in Pelvic Floor Disorders with a site in United States — 12 open to participants now, 16 under way, none of them phase 3. Pelvic Floor Disorders · United States.
Among the 61 studies in Pelvic Floor Disorders with a site in United States, this one is the 14th largest by enrollment of the 50 interventional ones that give a count, is one of 4 that started in 2017, is one of 38 with no phase, and was the 23rd registered.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
Browse Pelvic Floor Disorders studies →12 of the 61 studies in Pelvic Floor Disorders with a site in United States are open now. Recruiting first, the newest first:
Cassandra Kisby · Sites in United States
Ages 21+ · Women only
University of Cincinnati · Sites in United States
Ages 18+ · Women only
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18+ · Women only
Yale University · Sites in United States
Ages 18+ · Women only
University of Miami · Sites in United States
Ages 18–75 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 27 Pelvic Floor Disorders studies recruiting now, 17 (63%) set no upper age limit and 10 (37%) stop at 75 or younger; none take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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61 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 106 is above the median of 64 across 148 interventional studies indexed under Pelvic Floor Disorders.
Median enrollment 57 across the 50 interventional studies, 133 across the 11 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.
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11 of 61 have an industry lead sponsor. The 10 most frequent:
University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
University of Massachusetts, Worcester has 1 study filed under Pelvic Floor Disorders — fewer than ten, so there is no comparison to draw.
8 of the studies in Pelvic Floor Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT06689891Yale UniversityVideo-Based Pelvic Floor Muscle Therapy | 2026-12 |
| NCT06111209Brigham and Women's HospitalThe Anabolic Effect of Testosterone on Pelvic Floor Muscles | 2026-12-31 |
| NCT06796985University of MiamiBotox for Chronic Pelvic Pain | 2027-03-22 |
| NCT06798311University of ChicagoReducing Disparities in Urinary Control Symptoms for Minority Women | 2027-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 61 studies in Pelvic Floor Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of the study is to determine if In-person interpreters increases patient satisfaction of URGYN office visits compared to the use of phone interpreter services for Limited English Proficient (LEP) patients
This study is a randomized controlled trial. Patients presenting to the UMass Memorial UROGYN clinic will be screened for eligibility using the inclusion and exclusion criteria. LEP patients will be identified as patients that initiate conversation in a non-English language and are only able to communicate adequately regarding their medical problem in a non-English language.
After patients have been seen for their scheduled office visit, they will be invited to participate in the study. Once the patient has agreed to participate in the study the participant will be randomized. Study assignment will be revealed using sequentially numbered sealed opaque envelopes. Randomization will be performed using software and a block randomization scheme to yield a 50% chance of having an in-person interpreter.
Those assigned to the control group will receive phone translation services and the experimental group will have in person interpreters.
At the subsequent visit, demographic information will be collected and patients will then receive interpretation services from the phone or an in-person interpreter.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit
Other: Interpretation Modality: In Person
Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit
Other: Interpretation Modality: Telephonic
Use of In-Person interpretation support for LEP participant during clinical appointment
Use of telephonic interpretation support for LEP participant during clinical appointment
Patient Satisfaction
Patient satisfaction will be measured by a 14 - item questionnaire. The questionnaire was created, validated, and used in a previous study from the field of Emergency medicine. There are 3 subscales assessing patient satisfaction with interpreter, nursing, and physician. Satisfaction with interpreters was calculated using the summation index of 4 items. Satisfaction with physician and nursing communication was measure by a summated index of 5 items that measure increasing level of satisfaction with a likert scale. Answers ranged from 1 to 4 where 4 equaled "strongly agree" and 1 equaled "strongly disagree". All items were weighted on a 100 point scale to facilitate interpretation of the means. A lower score means less satisfaction/greater dissatisfaction and a higher score indicates more satisfaction/less dissatisfaction.
Time frame: Immediately assessed after office visit
| Milestone | Interpretation Modality: In Person | Interpretation Modality: Telephonic |
|---|---|---|
| Started | 49 | 57 |
| Completed | 38 | 40 |
| Not completed | 11 | 17 |
| Withdrew: Lost to follow-up | 11 | 17 |
Patient satisfaction will be measured by a 14 - item questionnaire. The questionnaire was created, validated, and used in a previous study from the field of Emergency medicine. There are 3 subscales assessing patient satisfaction with interpreter, nursing, and physician. Satisfaction with interpreters was calculated using the summation index of 4 items. Satisfaction with physician and nursing communication was measure by a summated index of 5 items that measure increasing level of satisfaction with a likert scale. Answers ranged from 1 to 4 where 4 equaled "strongly agree" and 1 equaled "strongly disagree". All items were weighted on a 100 point scale to facilitate interpretation of the means. A lower score means less satisfaction/greater dissatisfaction and a higher score indicates more satisfaction/less dissatisfaction.
| score on a scale | Interpretation Modality: In Person | Interpretation Modality: Telephonic |
|---|---|---|
| Patient Satisfaction | 100 (92.9 to 100) | 94 (94.0 to 98.8) |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interpretation Modality: In Person | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Interpretation Modality: Telephonic | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Interpretation Modality: In Person | Interpretation Modality: Telephonic | Total |
|---|---|---|---|
| Mean | 55.3 ± 9.9 | 52.4 ± 13.8 | 54.1 ± 11.1 |
| Sex: Female, Male(Participants) | Interpretation Modality: In Person | Interpretation Modality: Telephonic | Total |
|---|---|---|---|
| Female | 49 | 57 | 106 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Interpretation Modality: In Person | Interpretation Modality: Telephonic | Total |
|---|---|---|---|
| Hispanic or Latino | 25 | 30 | 55 |
| Not Hispanic or Latino | 24 | 27 | 51 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Language of Translation(Participants) | Interpretation Modality: In Person | Interpretation Modality: Telephonic | Total |
|---|---|---|---|
| Spanish | 25 | 30 | 55 |
| Portugese | 24 | 27 | 51 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Jun 2019, 17 months.
Results were first posted in Apr 2021, 1 year 9 months after primary completion.
Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 17 months is close to that.
Counting every sponsor, half of 107 studies reached it within 17 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Worcester →