Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
NCT Number: NCT06480227
Acronym: BASIS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress Urinary Incontinence|Urinary Incontinence|Mixed Urinary Incontinence
Interventions: DEVICE: Solyx Single-incision Sling|DEVICE: Bulkamid Transurethral Bulking Agent
Sponsor: NICHD Pelvic Floor Disorders Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Duke University|Kaiser Permanente|University of California, San Diego|University of Chicago|University of Pennsylvania|University of Texas Southwestern Medical Center|Women and Infants Hospital of Rhode Island|RTI International
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 358
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2029-06
Locations: University of California at San Diego, La Jolla, California, 92037-0974, United States|Kaiser Permanente -- San Diego, San Diego, California, 92110, United States|University of Chicago, Chicago, Illinois, 60637, United States|Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham, North Carolina, 27707, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence, Rhode Island, 02903, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States

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" improved 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).

Primary Outcome Measures: Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months., 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., At 12 months post-intervention.
Secondary Outcome Measures: Rates of retreatment, 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., From intervention to 12 months post-intervention.|Change in Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF] score, 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., From intervention to 36 months post-intervention.|Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS, 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., From 3 months to 36 months post-intervention.|Condition improvement measured by Patient Global Symptom Control [PGSC] for TBA vs. SIS, 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., From interventions to 36 months post-intervention.|Condition improvement measured by Patient Global Impression of Severity [PGI-S] for TBA vs. SIS, 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., From intervention to 36 months post-intervention.|Condition improvement measured by Urogenital Distress Inventory - Long Form [UDI-LF] for TBA vs. SIS, 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., From intervention to 36 months post-intervention.|Objective success by standardized cough testing, 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), From 3 to 12 months post-intervention.|New or worsening urge incontinence function, 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), From intervention to 36 months post-intervention.|Sexual functional measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised [PISQ-IR] for TBA vs. SIS, 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., From intervention to 36 months post-intervention.|Quality of life improvement measured by Incontinence Impact Questionnaire - Long Form [IIQ-LF] for TBA vs. SIS, 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., From baseline to 36 months post-intervention.|Quality of life improvement measured by 36-Item Short Form Health Survey [SF-36] for TBA vs. SIS, 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., From baseline to 36 months post-intervention.|Quality of life improvement measured by Decision Regret Scale- Satisfaction with Decision Scale [DRS-SDS] for TBA vs. SIS, 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., From baseline to 36 months post-intervention.|Blood Loss, Estimated quantity of blood lost during protocol procedures., At intervention|Operative time, Estimated total time of operative procedure, At intervention|Operative Procedure-related adverse events, 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., At intervention|Post-op pain, 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, Between 3 and 12 months post-intervention|Intraoperative Pain management, Number of participants with intraoperative need for additional sedation or anesthesia beyond local injection., At intervention|Functional activity measured by Activity Assessment Scale [AAS] for TBA vs. SIS, 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., From intervention to 36 months post-intervention.|Medical resource use, 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., From intervention to 36 months post-intervention.|Medical Resource Cost, 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., From intervention to 36 months post-intervention.|Health utility measure measured by the European Quality of Life-5 Dimensions (EQ-5D-5L), 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, From baseline to 36 months post-intervention.