Female Stress Incontinence
Conditions
Brief summary
This is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.
Detailed description
In this randomized trial, eligible patients who provide written consent for participation will be enrolled. At enrollment we will collect baseline demographic data and ask participants to complete questionnaires and a 3-day bladder diary. Subjects will be randomized in a 1:1 ratio to continence pessary or disposable intravaginal device.
Interventions
DEVICEContinence 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.
DEVICEPoise 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.
Sponsors
University of North Carolina, Chapel Hill
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
parallel group design with participants randomized to either DICD or CP (active treatment concurrent control) in a 1:1 allocation ratio for a 4-week treatment period followed by a six-month phone call follow-up to assess continued use and other treatment utilization after the initial study treatment phase.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 21 years or older (based on disposable intravaginal device manufacturing recommendations). * SUI or SUI-predominant mixed incontinence * English-speaking
Exclusion criteria
* Pregnancy * Current symptomatic urinary tract infection (UTI). * Postmenopausal bleeding of unknown etiology * Neurogenic bladder * Urinary retention (PVR \>150mL obtained via bladder scan or catheterization) * Pelvic organ prolapse past the hymen as assessed by POP-Q examination * Inability to complete questionnaires in English or comply with study protocol * Contraindication to pessary or disposable intravaginal device use or prior treatment or experience with either intervention. * Prior surgery for stress urinary incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | 4 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validated Questionnaires | 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. |
| Satisfaction With Device | 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. |
| Adverse Events | 4 weeks | Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI) |
| 6 Month Follow up | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | alternative treatment | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 5 |
| Overall Study | Withdrawal by Subject | 14 | 11 |
Baseline characteristics
| Characteristic | Disposable Intravaginal Device | Total | Continence Pessary |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Continuous | 41 years | 44 years | 47 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 1 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Treatment Success
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).
Time frame: 4 weeks
Population: Discrepancy in analyzed numbers is secondary to patients either withdrawing from study, lost to follow up, or choosing alternative treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continence Pessary | Treatment Success | 8 Participants |
| Disposable Intravaginal Device | Treatment Success | 9 Participants |
Secondary
6 Month Follow up
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
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continence Pessary | 6 Month Follow up | Still using device | 5 Participants |
| Continence Pessary | 6 Month Follow up | Using Pessary | 0 Participants |
| Continence Pessary | 6 Month Follow up | Physical therapy | 0 Participants |
| Continence Pessary | 6 Month Follow up | Satisfied with treatment | 4 Participants |
| Disposable Intravaginal Device | 6 Month Follow up | Satisfied with treatment | 5 Participants |
| Disposable Intravaginal Device | 6 Month Follow up | Still using device | 4 Participants |
| Disposable Intravaginal Device | 6 Month Follow up | Physical therapy | 1 Participants |
| Disposable Intravaginal Device | 6 Month Follow up | Using Pessary | 2 Participants |
Secondary
Adverse Events
Potential adverse events of interest include vaginal discomfort, vaginal bleeding, vaginal infection, vaginal abrasion/laceration, and urinary tract infection (UTI)
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continence Pessary | Adverse Events | 1 Participants |
| Disposable Intravaginal Device | Adverse Events | 0 Participants |
Secondary
Satisfaction With Device
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Continence Pessary | Satisfaction With Device | High likely to continue using | 8 participants |
| Continence Pessary | Satisfaction With Device | Satisfied with device | 5 participants |
| Continence Pessary | Satisfaction With Device | Device is comfortable | 7 participants |
| Continence Pessary | Satisfaction With Device | Device is easy to use | 8 participants |
| Disposable Intravaginal Device | Satisfaction With Device | Device is easy to use | 12 participants |
| Disposable Intravaginal Device | Satisfaction With Device | High likely to continue using | 7 participants |
| Disposable Intravaginal Device | Satisfaction With Device | Device is comfortable | 10 participants |
| Disposable Intravaginal Device | Satisfaction With Device | Satisfied with device | 4 participants |
Secondary
Validated Questionnaires
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continence Pessary | Validated Questionnaires | UDI-6 | 110 score on a scale | Standard Deviation 135 |
| Continence Pessary | Validated Questionnaires | IIQ-7 | 10 score on a scale | Standard Deviation 30 |
| Continence Pessary | Validated Questionnaires | FSFI | -1 score on a scale | Standard Deviation 0 |
| Disposable Intravaginal Device | Validated Questionnaires | UDI-6 | 71 score on a scale | Standard Deviation 105 |
| Disposable Intravaginal Device | Validated Questionnaires | IIQ-7 | 7 score on a scale | Standard Deviation 12 |
| Disposable Intravaginal Device | Validated Questionnaires | FSFI | 1 score on a scale | Standard Deviation 2 |