An interventional study of Solyx Single-incision Sling and Bulkamid Transurethral Bulking Agent in Stress Urinary Incontinence, Urinary Incontinence and Mixed Urinary Incontinence, sponsored by NICHD Pelvic Floor Disorders Network. Recruiting at 7 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by NICHD Pelvic Floor Disorders Network · Not applicable, Interventional, and Treatment
Among 189 studies in Urinary Incontinence, Stress with a site in United States — 27 open to participants now, 40 under way, 3 of them phase 3. Urinary Incontinence, Stress · United States.
Among the 189 studies in Urinary Incontinence, Stress with a site in United States, this one is the 23rd largest by planned enrollment of the 163 interventional ones, is one of 7 that started in 2024, is one of 109 with no phase, reaches primary completion later than 31 of the 39 other live ones, and was the 172nd registered.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 358 is above the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →27 of the 189 studies in Urinary Incontinence, Stress with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.
This study: 21 Years and older · female · no healthy volunteers.
The full table on the hub →189 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 7 started in 2024.
Median enrollment 98 across the 163 interventional studies, 98 across the 26 observational. Of the 129 that completed or were terminated, 56 (43%) have results posted.
72 of 189 have an industry lead sponsor. The 10 most frequent:
NICHD Pelvic Floor Disorders Network is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
NICHD Pelvic Floor Disorders Network has 5 studies filed under Urinary Incontinence, Stress — fewer than ten, so there is no comparison to draw.
9 of the studies in Urinary Incontinence, Stress with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06968741UroMems SASA Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS) | 2026-12 |
| NCT06111209Brigham and Women's HospitalThe Anabolic Effect of Testosterone on Pelvic Floor Muscles | 2026-12-31 |
| NCT06369922University of RochesterTENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. | 2027-01-31 |
| NCT06706362Ohio State UniversityAssessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study) | 2027-04-15 |
| NCT07008898University of Alabama at BirminghamSequence of Midurethral Sling Placement During Robotic Sacrocolpopexy | 2027-05 |
Among the 189 studies in Urinary Incontinence, Stress with a site in United States, from their registry updates:
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Solyx Single-incision Sling
Device: Solyx Single-incision Sling
Bulkamid Transurethral Bulking Agent
Device: Bulkamid Transurethral Bulking Agent
Minimally invasive mesh device placed to treat stress urinary incontinence.
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
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.
Time frame: At 12 months post-intervention.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 36 months post-intervention.
Blood Loss
Estimated quantity of blood lost during protocol procedures.
Time frame: At intervention
Operative time
Estimated total time of operative procedure
Time frame: 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.
Time frame: 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
Time frame: Between 3 and 12 months post-intervention
Intraoperative Pain management
Number of participants with intraoperative need for additional sedation or anesthesia beyond local injection.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From baseline to 36 months post-intervention.
Plan to share: Yes — Study data will be made available through DASH
Supporting information: Study protocol, Informed consent form
Time frame: Plan to submit full study dataset before the end of the award period.
Access criteria: Access is managed by DASH.
Data sharing details ↗ · dash.nichd.nih.gov
Started Aug 2024 (actual). Primary completion is estimated for Dec 2028, 52 months after the start.
Of 225 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 52 months is above that.
Counting every sponsor, half of 266 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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Urinary Incontinence, Stress →
NICHD Pelvic Floor Disorders Network