Stress Urinary IncontinenceLABNCT06043063
Local Anesthesia Before Bulkamid Injection
A study testing Topical lidocaine, EMLA cream and Periurethral block in people with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency, run by Medstar Health Research Institute at 3 sites in United States.
Trial summary
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Intrinsic Sphincter Deficiency
- What is being tested?
- Topical lidocaine, EMLA cream and Periurethral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2023to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG
- English-speaking
- Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia
Who cannot join
- Pregnancy
- Neurogenic bladder
- Pre-existing need for intermittent catheterization or indwelling catheter
- Bladder or urothelial malignancy
- Prior radiation to pelvic floor
- Known allergy/sensitivity to PAHG
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
MedStar Lafayette Medical Centre
Washington D.C., District of Columbia, 20036
About this study
Official title: Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.
- Being tested
- Topical lidocaine, EMLA cream, Periurethral block
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical lidocaineProcedure or surgery
Also called Intraurethral 2% lidocaine gel
Topical anesthetic
EMLA creamProcedure or surgery
Also called 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream
Topical anesthetic
Periurethral blockProcedure or surgery
Also called 1% lidocaine or 0.25% bupivacaine
5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock (periurethral tissues) to depth of 1.5 cm using 25G needle
| Study group | Role | What they receive |
|---|---|---|
| Topical anesthesia alone | Experimental | 2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min Receives: Procedure: Topical lidocaine; Procedure: EMLA cream |
| Topical anesthesia with periurethral block | Active comparator | 2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min
+ periurethral block (5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock to depth of 1.5 cm using 25G needle)
Block sits for 5 min if lidocaine, 10 min if bupivacaine Receives: Procedure: Topical lidocaine; Procedure: EMLA cream; Procedure: Periurethral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) for pain
Visual analog scale for pain uses a scale from 0-10 corresponding to reported pain levels with 0 indicating no pain and 10 indicating most severe pain possible
Measured: Ascertained at end of procedure (withdrawal of cystoscope)
Secondary outcomes (5)
Duration of procedure
in seconds
Measured: Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)
Incomplete bladder emptying
Inability to void after procedure
Measured: Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)
Need for re-injection of PAHG
Requirement for "top-off" or repeat injection due to persistent symptoms
Measured: Assessed at follow-up 2 weeks post-procedure
International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)
3 items on frequency/quantity of leakage and impact on quality on life (range 0-21 with lower score indicating lower severity of incontinence symptoms and higher score indicating higher severity of incontinence symptoms)
Measured: Assessed at baseline and at two-week and twelve-week follow-up visit
Patient Global Impression of Improvement scale (PGI-I)
1 item on relative change in symptoms following treatment (range 1-7 with lower score indicating greater improvement in incontinence symptoms following intervention and higher score indicating lower improvement in incontinence following intervention)
Measured: Assessed at two-week and twelve-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion16 Aug 2024
- Study completion23 Dec 2024
Why it stopped: Study was terminated prematurely due to meeting safety endpoint defined as 3 participants in the experimental arm requiring termination of in-office procedure due to pain.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043063
- Sponsor's protocol ID
- STUDY00006172
- Acronym
- LAB
- Status last verified
- May 2025
- First submitted
- 31 Aug 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06043063
- Acronym / sponsor ID
- LAB / STUDY00006172
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated prematurely due to meeting safety endpoint defined as 3 participants in the experimental arm requiring termination of in-office procedure due to pain.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical anesthesia alone | Experimental | Procedure: Topical lidocaine, Procedure: EMLA cream2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min |
| Topical anesthesia with periurethral block | Active comparator | Procedure: Topical lidocaine, Procedure: EMLA cream, Procedure: Periurethral block2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min + periurethral block (5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock to depth of 1.5 cm using 25G needle) Block sits for 5 min if lidocaine, 10 min if bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG
- English-speaking
- Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia
Key exclusion criteria (6 listed)
- Pregnancy
- Neurogenic bladder
- Pre-existing need for intermittent catheterization or indwelling catheter
- Bladder or urothelial malignancy
- Prior radiation to pelvic floor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical lidocaineAlso: Intraurethral 2% lidocaine gelTopical anesthetic | Procedure or surgery | Topical anesthesia alone, Topical anesthesia with periurethral block |
| EMLA creamAlso: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) creamTopical anesthetic | Procedure or surgery | Topical anesthesia alone, Topical anesthesia with periurethral block |
| Periurethral blockAlso: 1% lidocaine or 0.25% bupivacaine5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock (periurethral tissues) to depth of 1.5 cm using 25G needle | Procedure or surgery | Topical anesthesia with periurethral block |
Primary outcome
Visual analog scale (VAS) for pain
Time frame: Ascertained at end of procedure (withdrawal of cystoscope)
Visual analog scale for pain uses a scale from 0-10 corresponding to reported pain levels with 0 indicating no pain and 10 indicating most severe pain possible
5 secondary outcomes
Duration of procedure
Time frame: Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)
Incomplete bladder emptying
Time frame: Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)
Need for re-injection of PAHG
Time frame: Assessed at follow-up 2 weeks post-procedure
International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)
Time frame: Assessed at baseline and at two-week and twelve-week follow-up visit
Patient Global Impression of Improvement scale (PGI-I)
Time frame: Assessed at two-week and twelve-week follow-up visit
Results and safety
The study was stopped early (reason given: Study was terminated prematurely due to meeting safety endpoint defined as 3 participants in the experimental arm requiring termination of in-office procedure due to pain.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical lidocaine, EMLA cream and Periurethral block in people with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency, run by Medstar Health Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated prematurely due to meeting safety endpoint defined as 3 participants in the experimental arm requiring termination of in-office procedure due to pain.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) for pain (time frame: Ascertained at end of procedure (withdrawal of cystoscope)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.