Mixed Urinary Incontinence, Stress Urinary Incontinence, Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Pelvic Floor Disorders, Single Incision Sling, Transurethral Bulking Agent
Brief summary
This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).
Detailed description
The BASIS trial is a multicentered, double-blind, randomized controlled, surgical trial with two active interventions, 1) a transurethral bulking agent (TBA) or 2) a single-incision sling (SIS). Both interventions are FDA-approved treatment options for urinary incontinence and will be used in line with their approved use. Participants will be randomly assigned to one of the interventions. A total of 358 women will be randomized 1:1 to TBA or SIS. All participants will have data including demographics, medical history, and quality of life assessments as they relate to urinary incontinence collected at baseline. After undergoing treatment (either transurethral bulking agent or single-incision sling), participants will be asked to return to the clinic at 2-4 weeks, 3 months, and 12 months with additional follow-ups at 6 months, 24 months, and 36 months done over the phone. The primary outcome of the BASIS trial is subjective success measured by PGI-I for TBA vs. SIS at 12 months. Secondary outcomes include assessments of 1) retreatment rates within 12 months; 2) validated, objective measures of condition improvement through 36 months; 3) objective success at 3 and 12 months as measured by standardized cough stress test; 4) functional outcomes (activity level, perceived recover, sexual function, etc.); 5) quality of life assessments; 6) operative procedure data and adverse events; 7) pain and functional activity, need for sedation and anesthesia, de novo or worsening symptoms; 8) medical resource use (additional medications, procedures, or therapies); and 9) healthy utility measures.
Interventions
DEVICESolyx Single-incision Sling
Minimally invasive mesh device placed to treat stress urinary incontinence.
DEVICEBulkamid Transurethral Bulking Agent
Minimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed
Sponsors
NICHD Pelvic Floor Disorders Network
Duke University
Kaiser Permanente
University of Chicago
University of Pennsylvania
University of Texas Southwestern Medical Center
Women and Infants Hospital of Rhode Island
RTI International
University of California, San Diego
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ≥ 21 years * For \> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required. * A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months. * Normal PVR \< 150 mL * Candidate for either study procedure as determined by treating surgeon * Available for up to 3 years. * Agrees to randomization.
Exclusion criteria
* Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ) * Urge-predominant mixed UI despite stable therapy * Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment. * Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months. * Malignancy or history of radiation of the pelvis * Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year * Incomplete emptying (PVR \> 150mL) * Prior anti-incontinence procedure * Neurogenic bladder * Unwilling to continue current UUI treatment until completion of primary outcome at 12 months * Prior adverse reaction to synthetic mesh or urethral bulking material * Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.) * Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months. | At 12 months post-intervention. | The PGI-I is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. Determine the comparative effectiveness (as defined by "much" or "very much" improved on PGI-I) of transurethral bulking agent \[for 1 or 2 injections in 12 months\] vs. single-incision sling 12 months after treatment intervention in women with predominant stress urinary incontinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS | From 3 months to 36 months post-intervention. | The PGI-I is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. Determine the comparative effectiveness (as defined by "much" or "very much" improved on PGI-I) of transurethral bulking agent \[for 1 or 2 injections in 12 months\] vs. single-incision sling 12 months after treatment intervention in women with predominant stress urinary incontinence. PGI-I at each follow up time point up to 36 months according to treatment assignment and as treated. |
| Condition improvement measured by Patient Global Symptom Control [PGSC] for TBA vs. SIS | From interventions to 36 months post-intervention. | The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree) PGSC is collected at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Condition improvement measured by Patient Global Impression of Severity [PGI-S] for TBA vs. SIS | From intervention to 36 months post-intervention. | The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). The outcomes is calculated as those that reported Normal or Mild severity as indicated by a rating of 1 or 2. PGI-S at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Condition improvement measured by Urogenital Distress Inventory - Long Form [UDI-LF] for TBA vs. SIS | From intervention to 36 months post-intervention. | The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. UDI-LF is collected at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Objective success by standardized cough testing | From 3 to 12 months post-intervention. | Objective success at 3 and 12 months after TBA (1 or 2 injections) vs. SIS by standardized cough testing with a minimum 300 mL bladder volume. (Note, objective failure may be present below 300 mL) |
| New or worsening urge incontinence function | From intervention to 36 months post-intervention. | Number of participants with new or worsening onset urge urinary incontinence (UUI) (including need for additional or change in UUI treatment in those on UUI therapy at baseline) |
| Sexual functional measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised [PISQ-IR] for TBA vs. SIS | From intervention to 36 months post-intervention. | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. PISQ-IR is collected at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Quality of life improvement measured by Incontinence Impact Questionnaire - Long Form [IIQ-LF] for TBA vs. SIS | From baseline to 36 months post-intervention. | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIQ-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. IIQ-LF is collected at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Quality of life improvement measured by 36-Item Short Form Health Survey [SF-36] for TBA vs. SIS | From baseline to 36 months post-intervention. | The SF-36 determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Scores range from 0 to 100 with higher scores indicating better quality of life. SF-36 is collected at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Quality of life improvement measured by Decision Regret Scale- Satisfaction with Decision Scale [DRS-SDS] for TBA vs. SIS | From baseline to 36 months post-intervention. | The DRS-SDS is a standardized assessment of treatment satisfaction. It asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Higher scores are worse. DRS-SDS at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Blood Loss | At intervention | Estimated quantity of blood lost during protocol procedures. |
| Operative time | At intervention | Estimated total time of operative procedure |
| Operative Procedure-related adverse events | At intervention | Number of participants with intra- and post-operative complications requiring treatment or any treatment for voiding dysfunction or pain, categorized using a modification of the Dindo Classification. |
| Post-op pain | Between 3 and 12 months post-intervention | Number of participants with de novo or worsening pelvic floor muscle tenderness or de novo or worsening dyspareunia or surgical pain between 3 and 12 months |
| Intraoperative Pain management | At intervention | Number of participants with intraoperative need for additional sedation or anesthesia beyond local injection. |
| Functional activity measured by Activity Assessment Scale [AAS] for TBA vs. SIS | From intervention to 36 months post-intervention. | The AAS is a is a standardized a measure of impact of incontinence on normal and more strenuous activities. The score ranges from 0 to 100 with higher scores indicating greater functional activity. AAS is collected at at baseline and each follow up time point up to 36 months according to treatment assignment and as treated. |
| Medical resource use | From intervention to 36 months post-intervention. | The number of participants with new medications, new symptoms or complaints, life events, and intercurrent therapies for incontinence and other urinary symptoms, intercurrent complications from treatment, intercurrent therapies for complications. |
| Medical Resource Cost | From intervention to 36 months post-intervention. | The estimated direct and indirect cost of the intervention, new medications, new symptoms or complaints, life events, and intercurrent therapies for incontinence and other urinary symptoms, intercurrent complications from treatment, intercurrent therapies for complications. |
| Health utility measure measured by the European Quality of Life-5 Dimensions (EQ-5D-5L) | From baseline to 36 months post-intervention. | European Quality of Life-5 Dimensions (EQ-5D-5L) is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The EQ-5D-5L has 5 attributes (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems |
| Change in Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF] score | From intervention to 36 months post-intervention. | The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage, for a range of scores from 0 (no leakage or bother) to 21 (worst leakage, most bothersome). A fourth question asks which type(s) of leakage are occurring. The ICIQ-SF score is collected at baseline and each follow-up time point up to 36 months according to treatment assignment and as treated. |
| Rates of retreatment | From intervention to 12 months post-intervention. | Rates of additional, non-protocol treatments (including other medications, therapies, or medical procedures) for stress urinary incontinence within 12 months after the initial TBA vs. SIS including success rates after 1 vs 2 TBA injections. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily Lukacz, MD
University of California, San Diego
PRINCIPAL_INVESTIGATORMarie Gantz, MD
RTI International
Outcome results
None listed