Trial Outcomes & Findings for Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation (NCT NCT04807387)
NCT ID: NCT04807387
Last Updated: 2024-08-06
Results Overview
Participants will report daily on stent comfort and any disruption to normal daily activities.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
24 hours from stent placement
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Ring Stent First, Then Flower Stent
Healthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent.
Vaginal Stent A: Ring stent
Vaginal Stent B: Flower stent
|
Flower Stent First, Then Ring Stent
Healthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent.
Vaginal Stent B: Flower stent
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Participants: Acute
n=6 Participants
Healthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent.
Vaginal Stent A: Ring stent
Vaginal Stent B: Flower stent
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 24 hours from stent placementParticipants will report daily on stent comfort and any disruption to normal daily activities.
Outcome measures
| Measure |
Healthy Participants: Acute - Vaginal Stent A: Ring Stent
n=4 Participants
Healthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent.
Vaginal Stent A: Ring stent
|
Healthy Participants: Acute - Vaginal Stent B: Flower Stent
n=5 Participants
Healthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent.
Vaginal Stent B: Flower stent
|
|---|---|---|
|
Number of Participants Reporting Vaginal Stent as Comfortable.
|
1 Participants
|
2 Participants
|
Adverse Events
Healthy Participants: Acute - Vaginal Stent A: Ring Stent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Participants: Acute - Vaginal Stent B: Flower Stent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place