Interstitial CystitisEarly Phase 1T3STOPBPSNCT05485207
Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome
A Early Phase 1 study testing Transvaginal botulinum toxin A (BTA) injection in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Stanford University at 1 site in United States.
Trial summary
Interstitial cystitis / bladder pain syndrome (IC/BPS) is a debilitating condition that affects millions of women in the United States. Women suffer from recurring pelvic pain, bladder pressure, painful bladder, urinary frequency (needing to go often) and urgency (feeling a strong need to go). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- Transvaginal botulinum toxin A (BTA) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 28 Feb 2025
- Phase
- Early Phase 1
- 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
- Females with IC/BPS
- Females who are considering intradetrusor BTA chemodenervation for the treatment of refractory IC/BPS
Who cannot join
- Involvement in other studies with potentially overlapping indications or symptoms
- Patients who are unable to undergo a transvaginal intervention as a result of anatomic barriers or discomfort will be excluded from enrollment
- patients known to be pregnant or breastfeeding
- Known allergy to BTA injection therapy or lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Urology Clinic (Stanford University), 1000 Welch Road, Suite 100
Palo Alto, California, 94304
About this study
Official title: T3STOPBPS: Open Label Clinical Trial of Transvaginal Trigone Treatment (T3) With Botulinum Toxin A (BTA) for Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)
Interstitial cystitis / bladder pain syndrome (IC/BPS) is a debilitating condition that affects millions of women in the United States. Women suffer from recurring pelvic pain, bladder pressure, painful bladder, urinary frequency (needing to go often) and urgency (feeling a strong need to go). Women are five times more likely to suffer from IC/BPS than men. IC/BPS is a common cause of painful bladder after excluding urinary tract infection. About one-third of women resort to opioids, thus contributing to the current opioid crisis. Sadly, there are no durable treatments and the majority of therapies are not FDA-approved for IC/BPS.
Read the detailed description
Botulinum toxin A (BTA) injected into the bladder wall off-label for the IC/BPS indication has been effective in many women. Unfortunately most women cannot get BTA injection without general anesthesia due to pain from cystoscopy (small camera placed in the bladder). Dr. Dobberfuhl and her team created the transvaginal trigone treatment (T3) approach. Dr. Dobberfuhl was the first investigator in the world to complete a clinical trial of 31 injections of T3 BTA through the vaginal approach, for a non-painful condition, overactive bladder.
The T3STOPBPS study is an open label dose-escalation clinical study of BTA, for women with refractory IC/BPS. BTA is injected through the vaginal wall using a simple technique, the T3 approach, without the need for anesthesia or cystoscopy. The T3 BTA injection procedure has been well tolerated. The T3STOPBPS study will generate data needed for NIH R01 funding which will 1. Bring us closer to making T3 BTA available to women with IC/BPS, 2. Identify neuropeptide (pain) signaling targets for new IC/BPS therapies, and 3. Improve our understanding of fNIRS brain connectivity associated with IC/BPS treatment success.
Twelve patients will be recruited from the clinical practice of Dr. Dobberfuhl to undergo 50 unit T3 BTA injection at baseline. Psychometrically validated questionnaires (AUASS, ICIQ FLUTS, SF12, OLS ICSI / ICPI), voiding diaries, fNIRS and whole urine will be obtained at baseline (pre-treatment), 6 and 12 weeks after T3 BTA. Noninvasive fNIRS brain testing will be performed in collaboration with Dr. Hosseini, which will assess changes in cerebral connectivity from baseline. Whole urine will assess changes in neuropeptide molecular signaling using bulk RNA sequencing following T3 BTA treatment. RNA sequencing will be correlated with our single cell sequencing bladder biopsy data in IC/BPS. Following 50 unit T3 BTA injection, after the 12 week study visit, subjects will be offered dose escalation to 100 units if they do not achieve >50% improvement in PGIC. Milestone for T3 BTA efficacy will be met if >50% improvement is achieved in PGIC versus baseline. Subjects will be eligible for repeat BTA injection when they report less than 50% improvement in symptoms according to the patient global impression of change (PGIC) scale after the 12 week study visit. This will help us understand how long the effect of the BTA lasts, which is typically 3 to 12 months with the traditional cystoscopic route of delivery. A new consent form will be signed at the time of repeat injection.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- Transvaginal botulinum toxin A (BTA) injection
- Keywords
- IC/BPS
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal botulinum toxin A (BTA) injectionDrug
Also called Botox® 100 units
Botulinum toxin A (Botox® 100 units) will be injected into the detrusor muscle of the bladder by inserting a needle through the anterior vaginal wall.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Botulinum Toxin A (BTA) injection | Experimental | Botulinum toxin A (Botox® 100 units) will be injected into the detrusor muscle of the bladder by inserting a needle through the anterior vaginal wall. Receives: Drug: Transvaginal botulinum toxin A (BTA) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Patient Global Impression of Change (PGIC) scale
Patients will be classified as treatment success if they achieve our primary efficacy outcome of a >50% improvement in the Patient Global Impression of Change (PGIC) scale
Measured: Baseline through week 12
Secondary outcomes (4)
Change from baseline in American Urological Association Symptom Score (AUASS)
American Urological Association Symptom Score
Measured: Baseline through week 12
Change from baseline in International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ FLUTS)
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms
Measured: Baseline through week 12
Change from baseline in Short Form 12-item Survey (SF12)
Short Form 12-item Survey
Measured: Baseline through week 12
Change from baseline in O'Leary Sant (OLS) Symptom Score [Interstitial Cystitis Symptom Index (ICSI) / Interstitial Cystitis Problem Index (ICPI)]
O'Leary Sant Symptom Score (Interstitial Cystitis Symptom Index / Interstitial Cystitis Problem Index)
Measured: Baseline through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start4 Apr 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- McCormick and Gabilan Faculty Fellowship Award
- Responsible party
- Principal investigator, Amy Diane Dobberfuhl, Stanford University
- Investigators
- Amy D. Dobberfuhl, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485207
- Sponsor's protocol ID
- IRB-58532
- Acronym
- T3STOPBPS
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Syan R, Briggs MA, Olivas JC, Srivastava S, Comiter CV, Dobberfuhl AD. Transvaginal ultrasound guided trigone and bladder injection: A cadaveric feasibility study for a novel route of intradetrusor chemodenervation. Investig Clin Urol. 2019 Jan;60(1):40-45. doi: 10.4111/icu.2019.60.1.40. Epub 2018 Dec 24.
PubMed 30637360Dobberfuhl AD, van Uem S, Versi E. Trigone as a diagnostic and therapeutic target for bladder-centric interstitial cystitis/bladder pain syndrome. Int Urogynecol J. 2021 Dec;32(12):3105-3111. doi: 10.1007/s00192-021-04878-9. Epub 2021 Jun 22.
PubMed 34156506Dobberfuhl AD. Pathophysiology, assessment, and treatment of overactive bladder symptoms in patients with interstitial cystitis/bladder pain syndrome. Neurourol Urodyn. 2022 Nov;41(8):1958-1966. doi: 10.1002/nau.24958. Epub 2022 May 24.
PubMed 35607890
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T3STOPBPS: Open Label Clinical Trial of Transvaginal Trigone Treatment (T3) With Botulinum Toxin A (BTA) for Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)
- ClinicalTrials.gov ID
- NCT05485207
- Acronym / sponsor ID
- T3STOPBPS / IRB-58532
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- IC/BPS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- McCormick and Gabilan Faculty Fellowship Award
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 3 Aug 2022 (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.
Interstitial cystitis / bladder pain syndrome (IC/BPS) is a debilitating condition that affects millions of women in the United States. Women suffer from recurring pelvic pain, bladder pressure, painful bladder, urinary frequency (needing to go often) and urgency (feeling a strong need to go). Women are five times more likely to suffer from IC/BPS than men. IC/BPS is a common cause of painful bladder after excluding urinary tract infection. About one-third of women resort to opioids, thus contributing to the current opioid crisis. Sadly, there are no durable treatments and the majority of therapies are not FDA-approved for IC/BPS.
Detailed description
Botulinum toxin A (BTA) injected into the bladder wall off-label for the IC/BPS indication has been effective in many women. Unfortunately most women cannot get BTA injection without general anesthesia due to pain from cystoscopy (small camera placed in the bladder). Dr. Dobberfuhl and her team created the transvaginal trigone treatment (T3) approach. Dr. Dobberfuhl was the first investigator in the world to complete a clinical trial of 31 injections of T3 BTA through the vaginal approach, for a non-painful condition, overactive bladder.
The T3STOPBPS study is an open label dose-escalation clinical study of BTA, for women with refractory IC/BPS. BTA is injected through the vaginal wall using a simple technique, the T3 approach, without the need for anesthesia or cystoscopy. The T3 BTA injection procedure has been well tolerated. The T3STOPBPS study will generate data needed for NIH R01 funding which will 1. Bring us closer to making T3 BTA available to women with IC/BPS, 2. Identify neuropeptide (pain) signaling targets for new IC/BPS therapies, and 3. Improve our understanding of fNIRS brain connectivity associated with IC/BPS treatment success.
Twelve patients will be recruited from the clinical practice of Dr. Dobberfuhl to undergo 50 unit T3 BTA injection at baseline. Psychometrically validated questionnaires (AUASS, ICIQ FLUTS, SF12, OLS ICSI / ICPI), voiding diaries, fNIRS and whole urine will be obtained at baseline (pre-treatment), 6 and 12 weeks after T3 BTA. Noninvasive fNIRS brain testing will be performed in collaboration with Dr. Hosseini, which will assess changes in cerebral connectivity from baseline. Whole urine will assess changes in neuropeptide molecular signaling using bulk RNA sequencing following T3 BTA treatment. RNA sequencing will be correlated with our single cell sequencing bladder biopsy data in IC/BPS. Following 50 unit T3 BTA injection, after the 12 week study visit, subjects will be offered dose escalation to 100 units if they do not achieve >50% improvement in PGIC. Milestone for T3 BTA efficacy will be met if >50% improvement is achieved in PGIC versus baseline. Subjects will be eligible for repeat BTA injection when they report less than 50% improvement in symptoms according to the patient global impression of change (PGIC) scale after the 12 week study visit. This will help us understand how long the effect of the BTA lasts, which is typically 3 to 12 months with the traditional cystoscopic route of delivery. A new consent form will be signed at the time of repeat injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Botulinum Toxin A (BTA) injection | Experimental | Drug: Transvaginal botulinum toxin A (BTA) injectionBotulinum toxin A (Botox® 100 units) will be injected into the detrusor muscle of the bladder by inserting a needle through the anterior vaginal wall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females with IC/BPS
- Females who are considering intradetrusor BTA chemodenervation for the treatment of refractory IC/BPS
Key exclusion criteria (4 listed)
- Involvement in other studies with potentially overlapping indications or symptoms
- Patients who are unable to undergo a transvaginal intervention as a result of anatomic barriers or discomfort will be excluded from enrollment
- patients known to be pregnant or breastfeeding
- Known allergy to BTA injection therapy or lidocaine
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 |
|---|---|---|
| Transvaginal botulinum toxin A (BTA) injectionAlso: Botox® 100 unitsBotulinum toxin A (Botox® 100 units) will be injected into the detrusor muscle of the bladder by inserting a needle through the anterior vaginal wall. | Drug | Transvaginal Botulinum Toxin A (BTA) injection |
Primary outcome
Change from baseline in Patient Global Impression of Change (PGIC) scale
Time frame: Baseline through week 12
Patients will be classified as treatment success if they achieve our primary efficacy outcome of a >50% improvement in the Patient Global Impression of Change (PGIC) scale
4 secondary outcomes
Change from baseline in American Urological Association Symptom Score (AUASS)
Time frame: Baseline through week 12
Change from baseline in International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ FLUTS)
Time frame: Baseline through week 12
Change from baseline in Short Form 12-item Survey (SF12)
Time frame: Baseline through week 12
Change from baseline in O'Leary Sant (OLS) Symptom Score [Interstitial Cystitis Symptom Index (ICSI) / Interstitial Cystitis Problem Index (ICPI)]
Time frame: Baseline through week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 30637360Syan R, Briggs MA, Olivas JC, Srivastava S, Comiter CV, Dobberfuhl AD. Transvaginal ultrasound guided trigone and bladder injection: A cadaveric feasibility study for a novel route of intradetrusor chemodenervation. Investig Clin Urol. 2019 Jan;60(1):40-45. doi: 10.4111/icu.2019.60.1.40. Epub 2018 Dec 24.
- Background: PubMed 34156506Dobberfuhl AD, van Uem S, Versi E. Trigone as a diagnostic and therapeutic target for bladder-centric interstitial cystitis/bladder pain syndrome. Int Urogynecol J. 2021 Dec;32(12):3105-3111. doi: 10.1007/s00192-021-04878-9. Epub 2021 Jun 22.
- Background: PubMed 35607890Dobberfuhl AD. Pathophysiology, assessment, and treatment of overactive bladder symptoms in patients with interstitial cystitis/bladder pain syndrome. Neurourol Urodyn. 2022 Nov;41(8):1958-1966. doi: 10.1002/nau.24958. Epub 2022 May 24.
- 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.
Amy D. Dobberfuhl, M.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transvaginal botulinum toxin A (BTA) injection in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Stanford University at 1 site 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Change from baseline in Patient Global Impression of Change (PGIC) scale (time frame: Baseline through week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485207, which also lists 3 linked publications.
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 19 Apr 2024.