Stress Urinary IncontinenceBASISNCT06480227
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
A study testing Solyx Single-incision Sling and Bulkamid Transurethral Bulking Agent in people with Stress Urinary Incontinence and Urinary Incontinence, run by NICHD Pelvic Floor Disorders Network at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urinary Incontinence, Mixed Urinary Incontinence
- What is being tested?
- Solyx Single-incision Sling and Bulkamid Transurethral Bulking Agent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Aug 2024to 31 Dec 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jinxuan (Rowena) Shi, 872-724-0774, jinxuan.shi@bsd.uchicago.edu
Kimberly Kenton, MD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Agnes Burris, (214) 645-3833, Agnes.Burris@UTSouthwestern.edu
David Rahn, MD
- Recruiting
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707
Stephanie Yu, (919) 401-1016, stephanie.yu@duke.edu
Nazema Siddiqui, MD
- Recruiting
University of California at San Diego
La Jolla, California, 92037-0974
Kyle Herrala, (858) 657-6827, UrogynRSCH@ucsd.edu
Emily Lukacz, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Zandra Kennedy, (215) 615-6569, zandra.kennedy@pennmedicine.upenn.edu
Heidi Harvie, MD
- Recruiting
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, Rhode Island, 02903
Madeline Malloy, (401) 430-8228, MMMalloy@wihri.org
Vivian Sung, MD
- Recruiting
Kaiser Permanente -- San Diego
San Diego, California, 92110
Gisselle Zazueta-Damian, 619-821-5717, gisselle.zazueta-damian@kp.org
Linda Mackinnon, 619-821-6009, linda.m.mackinnon@kp.org
About this study
Official title: A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
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).
Read the 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.
- Being tested
- Solyx Single-incision Sling, Bulkamid Transurethral Bulking Agent
- Keywords
- Urinary Incontinence, Pelvic Floor Disorders, Single Incision Sling, Transurethral Bulking Agent
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solyx Single-incision SlingDevice
Minimally invasive mesh device placed to treat stress urinary incontinence.
Bulkamid Transurethral Bulking AgentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Solyx Single-incision Sling | Active comparator | Solyx Single-incision Sling Receives: Device: Solyx Single-incision Sling |
| Bulkamid Transurethral Bulking Agent | Active comparator | Bulkamid Transurethral Bulking Agent Receives: Device: Bulkamid Transurethral Bulking Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months post-intervention.
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 36 months post-intervention.
Blood Loss
Estimated quantity of blood lost during protocol procedures.
Measured: At intervention
Operative time
Estimated total time of operative procedure
Measured: 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.
Measured: 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
Measured: Between 3 and 12 months post-intervention
Intraoperative Pain management
Number of participants with intraoperative need for additional sedation or anesthesia beyond local injection.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From baseline to 36 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start28 Aug 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- 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)
- Responsible party
- Sponsor
- Investigators
- Emily Lukacz, MD, Principal investigator, University of California, San DiegoMarie Gantz, MD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480227
- Sponsor's protocol ID
- PFDN-33P01
- Other IDs
- UG1HD069013, UG1HD054214, UG1HD041267, UG1HD054241, UG1HD110057, UG1HD069010, U24HD069031
- Acronym
- BASIS
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study data will be made available through DASH
Publications
Lukacz ES, Menefee SA, Carper B, Collins S, McMillian K, Florian-Rodriguez M, Rardin C, Weidner AC, Harvie HS, Alexander B, Mazloomdoost D; NICHD Pelvic Floor Disorders Network. Design of Transurethral Bulking Agent Injection Versus Single-Incision Sling Trial. Urogynecology (Phila). 2026 Feb 1;32(2):131-141. doi: 10.1097/SPV.0000000000001702.
PubMed 41428458