Trial Outcomes & Findings for Continence Pessary Versus Disposable Intravaginal Device Trial (NCT NCT03174431)

NCT ID: NCT03174431

Last Updated: 2024-02-23

Results Overview

Success of stress urinary incontinence treatment is defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2024-02-23

Participant Flow

Exclusion criteria were pregnancy, current urinary tract infection (UTI), postmenopausal bleeding, neurogenic bladder, urinary retention, pelvic organ prolapse past the hymen, contraindication to device use, prior treatment with either device, and prior surgery for SUI. Women excluded for a current symptomatic UTI were eligible for enrollment after treatment was completed and a negative urine culture was obtained.

Participant milestones

Measure	Continence Pessary Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Overall Study STARTED	25	25
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	17	16

Reasons for withdrawal

Measure	Continence Pessary Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Overall Study Withdrawal by Subject	14	11
Overall Study alternative treatment	2	0
Overall Study Lost to Follow-up	1	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Continence Pessary n=25 Participants Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device n=25 Participants Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Continuous	47 years n=25 Participants	41 years n=25 Participants	44 years n=50 Participants
Sex: Female, Male Female	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Discrepancy in analyzed numbers is secondary to patients either withdrawing from study, lost to follow up, or choosing alternative treatment.

Success of stress urinary incontinence treatment is defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I).

Outcome measures

Measure	Continence Pessary n=10 Participants Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device n=12 Participants Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Treatment Success	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 4 weeks

Validated questionnaire scores obtained at baseline and week 4 with all questionnaires having higher scores indicating higher level of bother:

1. Urinary Distress Inventory (UDI-6): 6 questions measuring urinary incontinence symptom bother. Scale: 0-600.

2. Incontinence Impact Questionnaire (IIQ-7): 7 questions measuring functional impact of urinary incontinence. Scale: 0-100.

3. Female Sexual Function Index (FSFI) : 19 items use a 5-point Likert scale (1-5) to assess sexual functioning in women in 6 domains (Desire, arousal, lubrication, orgasm, satisfaction, pain). Sum of each domain is multiplied by a factor ratio (0.6: desire; 0.3: arousal and lubrication; 0.4: orgasm, satisfaction, and pain) to have all domain totals on a comparable scale.

Score ranges for each domain:

1. Desire: 1.2- 6

2. Arousal, lubrication, orgasm, and pain: 0- 6

3. Satisfaction: 0.8- 6 They are then summed to derive a total FSFI score of 2- 36.

Outcome measures

Measure	Continence Pessary n=10 Participants Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device n=12 Participants Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Validated Questionnaires UDI-6	110 score on a scale Standard Deviation 135	71 score on a scale Standard Deviation 105
Validated Questionnaires IIQ-7	10 score on a scale Standard Deviation 30	7 score on a scale Standard Deviation 12
Validated Questionnaires FSFI	-1 score on a scale Standard Deviation 0	1 score on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: 4 weeks

Satisfaction with device will be assessed using likert scale questionnaires assessing device satisfaction, ease of use, comfort, and likelihood of continued use at 4 weeks.

Outcome measures

Measure	Continence Pessary n=10 Participants Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device n=12 Participants Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Satisfaction With Device Satisfied with device	5 participants	4 participants
Satisfaction With Device Device is comfortable	7 participants	10 participants
Satisfaction With Device Device is easy to use	8 participants	12 participants
Satisfaction With Device High likely to continue using	8 participants	7 participants

SECONDARY outcome

Timeframe: 4 weeks

Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)

Outcome measures

Measure	Continence Pessary n=10 Participants Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device n=12 Participants Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Adverse Events	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

6 month intervention use and satisfaction with following questions as yes or no:

1. Still using device

2. Using other SUI treatment ( pessary, physical therapy)

3. Satisfied with treatment

Outcome measures

Measure	Continence Pessary n=8 Participants Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device n=9 Participants Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
6 Month Follow up Still using device	5 Participants	4 Participants
6 Month Follow up Using Pessary	0 Participants	2 Participants
6 Month Follow up Physical therapy	0 Participants	1 Participants
6 Month Follow up Satisfied with treatment	4 Participants	5 Participants

Adverse Events

Continence Pessary

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Disposable Intravaginal Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Continence Pessary n=25 participants at risk Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary. Continence Pessary: Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.	Disposable Intravaginal Device n=25 participants at risk Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices. Poise Impressa (Disposable Intravaginal Device): In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
Reproductive system and breast disorders Vaginal discomfort	4.0% 1/25 • Number of events 1 • 6 months from completion of study. There were no serious adverse events in the study. Only one adverse event occurred, a patient randomized to continence pessary removed the device after the fitting visit because of discomfort. She was treated with vaginal estrogen and was refit.	0.00% 0/25 • 6 months from completion of study. There were no serious adverse events in the study. Only one adverse event occurred, a patient randomized to continence pessary removed the device after the fitting visit because of discomfort. She was treated with vaginal estrogen and was refit.

Additional Information

Silpa Nekkanti

The Ohio State University

Phone: 614-293-4643

Email: silpa.nekkanti@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place