Urge Urinary IncontinencePhase 3ABCNCT01166438
Anticholinergic vs. Botox Comparison Study
A Phase 3 study testing Botulinum toxin A (Botox A®), Solifenacin 5mg and Solifenacin 10mg in people with Urge Urinary Incontinence and Overactive Bladder, run by NICHD Pelvic Floor Disorders Network at 11 sites in United States.
Trial summary
Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Urge Urinary Incontinence, Overactive Bladder
- What is being tested?
- Botulinum toxin A (Botox A®), Solifenacin 5mg and Solifenacin 10mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2010to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject has signed informed consent.
- Females at least 21 years of age
- Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
- Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
- Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required.
- Request for treatment for urge urinary incontinence. The patient may have tried other non-pharmacologic treatments for urge incontinence, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
- Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment.
- Subject is able to complete all study related items and interviews.
Who cannot join
- Any previous therapy with trospium chloride, solifenacin, or darifenacin
- Failed three or more anticholinergic drugs.
- Contraindication to anticholinergic therapy, specifically with solifenacin or trospium.
- Current symptomatic urinary tract infection that has not resolved prior to randomization.
- Uncontrolled narrow-angle glaucoma
- Gastric retention
Show all 27Show fewer
- Baseline need for intermittent self catheterization
- PVR >150ml on 2 occasions with void(s) of greater than 150ml
- Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
- Any prior intra-detrusor botulinum toxin A injections
- Previous or currently implanted neuromodulation (sacral or tibial).
- Surgically altered detrusor muscle, such as augmentation cystoplasty.
- Known allergy to botulinum toxin A.
- Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
- Known allergy to lidocaine.
- Currently pregnant or lactating patients or patients planning pregnancy within the next year.
- Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.
- Cystoscopic findings that preclude injection, in the opinion of the investigator.
- Current or prior bladder malignancy.
- In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
- Subjects who are on anticoagulant therapy,excluding aspirin
- Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
- Subjects with hematuria who have not undergone a clinically appropriate evaluation.
- Subjects taking aminoglycosides at the time of injection.
- Serum creatinine level greater than twice the upper limit of normal within the previous year.
- Two or more hospitalizations for medical conditions in the previous year.
- Plans to move out of area in the next 6 months.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Oakwood Hospital
Dearborn, Michigan, 48124
Duke University
Durham, North Carolina, 27710
USCD Medical Center
La Jolla, California, 92037
Loyola University Medical Center
Maywood, Illinois, 60153
Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213
Beaumont Hospital
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
Kaiser Permanente
San Diego, California, 92037
About this study
Official title: Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence
Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.
Read the detailed description
This study is a 6-month double-blind randomized trial comparing intra-detrusor botulinum toxin A (Botox A®) and anticholinergic therapy in women without neurologic disease with urge incontinence. Subjects will be followed up to an additional six months off study drug to determine duration of treatment effect.
The primary aim is to compare the change in urge incontinence episodes over 6 months between women receiving a single intra-detrusor injection of 100 unit of botulinum toxin A (Botox A®) plus daily oral placebo tablets versus women receiving a single intra-detrusor injection of saline plus daily anticholinergic therapy.
- Conditions
- Urge Urinary Incontinence, Overactive Bladder
- Being tested
- Botulinum toxin A (Botox A®), Solifenacin 5mg, Solifenacin 10mg, Trospium chloride
- Keywords
- incontinence, overactive bladder, botox, anticholinergic
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A (Botox A®)Drug
Also called (Botox A®)
A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
Solifenacin 5mgDrug
Also called Vesicare
Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mgDrug
Also called Vesicare
Oral Solifenacin 10mg once a day for up to 4 months
Trospium chlorideDrug
Also called Sanctura
Oral Trospium chloride XR 60mg once a day for up to 2 months
| Study group | Role | What they receive |
|---|---|---|
| Botox A | Experimental | A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets Receives: Drug: Botulinum toxin A (Botox A®) |
| Standardized Anticholinergic Regimen | Active comparator | A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium chloride XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study. Receives: Drug: Solifenacin 5mg; Drug: Solifenacin 10mg; Drug: Trospium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urge Urinary Incontinence (UUI) Episodes
Change from baseline in mean number of UUI episodes over 6 month double-blind period.
Measured: Baseline through 6 months
Secondary outcomes (4)
Change From Baseline in Score on OABq-SF
Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group.
Measured: Baseline through 6 months
Efficacy
Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI).
Measured: 6 months
Change in PFDI-SF and PFIQ-SF Total Scores
Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings.
Measured: Baseline through 6 months
Patient Global Impression of Improvement
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better).
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urge 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Anthony Visco, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166438
- Sponsor's protocol ID
- PFDN 17
- Other IDs
- 2U01HD041249, 2U10HD041250, 2U10HD041261, 2U10HD041267, 1U10HD054136, 1U10HD054214, 1U10HD054215, 1U10HD054241
- Acronym
- ABC
- Status last verified
- Apr 2018
- First submitted
- 19 Jul 2010
- Last updated
- 2 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Choi BI, Fontes Noronha M, Kaindl J, Wolfe AJ. Complete genome sequences of Aerococcus loyolae ATCC TSD-300T, Aerococcus mictus ATCC TSD-301T, and Aerococcus tenax ATCC TSD-302T. Microbiol Resour Announc. 2024 Jun 11;13(6):e0015624. doi: 10.1128/mra.00156-24. Epub 2024 Apr 23.
PubMed 38651909Hendrickson WK, Amundsen CL, Rahn DD, Meyer I, Bradley MS, Smith AL, Myers DL, Jelovsek JE, Lukacz ES. Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence. Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):140-146. doi: 10.1097/SPV.0000000000001020.
PubMed 33620895Visco AG, Zyczynski H, Brubaker L, Nygaard I, Xu X, Lukacz ES, Paraiso MF, Greer J, Rahn DD, Meikle SF, Honeycutt AA. Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):311-6. doi: 10.1097/SPV.0000000000000277.
PubMed 27564385Visco AG, Brubaker L, Jelovsek JE, Wilson TS, Norton P, Zyczynski HM, Spino C, Sirls L, Nguyen JN, Rahn DD, Meikle SF, Nolen TL; Pelvic Floor Disorders Network. Adherence to Oral Therapy for Urgency Urinary Incontinence: Results from the Anticholinergic Versus Botox Comparison (ABC) Trial. Female Pelvic Med Reconstr Surg. 2016 Jan-Feb;22(1):24-8. doi: 10.1097/SPV.0000000000000215.
PubMed 26516810Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012 Nov 8;367(19):1803-13. doi: 10.1056/NEJMoa1208872. Epub 2012 Oct 4.
PubMed 23036134Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Wei J, Chai T, Janz N, Spino C, Meikle S; Pelvic Floor Disorders Network. Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial. Contemp Clin Trials. 2012 Jan;33(1):184-96. doi: 10.1016/j.cct.2011.09.019. Epub 2011 Oct 8.
PubMed 22008247
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01166438
- Acronym / sponsor ID
- ABC / PFDN 17
- Conditions
- Urge Urinary Incontinence, Overactive Bladder
- Keywords
- incontinence, overactive bladder, botox, anticholinergic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Posted 6 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.
Detailed description
This study is a 6-month double-blind randomized trial comparing intra-detrusor botulinum toxin A (Botox A®) and anticholinergic therapy in women without neurologic disease with urge incontinence. Subjects will be followed up to an additional six months off study drug to determine duration of treatment effect.
The primary aim is to compare the change in urge incontinence episodes over 6 months between women receiving a single intra-detrusor injection of 100 unit of botulinum toxin A (Botox A®) plus daily oral placebo tablets versus women receiving a single intra-detrusor injection of saline plus daily anticholinergic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox A | Experimental | Drug: Botulinum toxin A (Botox A®)A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets |
| Standardized Anticholinergic Regimen | Active comparator | Drug: Solifenacin 5mg, Drug: Solifenacin 10mg, Drug: Trospium chlorideA standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium chloride XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has signed informed consent.
- Females at least 21 years of age
- Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
- Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
- Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required.
Key exclusion criteria (27 listed)
- Any previous therapy with trospium chloride, solifenacin, or darifenacin
- Failed three or more anticholinergic drugs.
- Contraindication to anticholinergic therapy, specifically with solifenacin or trospium.
- Current symptomatic urinary tract infection that has not resolved prior to randomization.
- Uncontrolled narrow-angle glaucoma
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 |
|---|---|---|
| Botulinum toxin A (Botox A®)Also: (Botox A®)A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices. | Drug | Botox A |
| Solifenacin 5mgAlso: VesicareOral Solifenacin 5mg once a day for up to 6 months | Drug | Standardized Anticholinergic Regimen |
| Solifenacin 10mgAlso: VesicareOral Solifenacin 10mg once a day for up to 4 months | Drug | Standardized Anticholinergic Regimen |
| Trospium chlorideAlso: SancturaOral Trospium chloride XR 60mg once a day for up to 2 months | Drug | Standardized Anticholinergic Regimen |
Primary outcome
Change in Urge Urinary Incontinence (UUI) Episodes
Time frame: Baseline through 6 months
Change from baseline in mean number of UUI episodes over 6 month double-blind period.
4 secondary outcomes
Change From Baseline in Score on OABq-SF
Time frame: Baseline through 6 months
Efficacy
Time frame: 6 months
Change in PFDI-SF and PFIQ-SF Total Scores
Time frame: Baseline through 6 months
Patient Global Impression of Improvement
Time frame: 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38651909Choi BI, Fontes Noronha M, Kaindl J, Wolfe AJ. Complete genome sequences of Aerococcus loyolae ATCC TSD-300T, Aerococcus mictus ATCC TSD-301T, and Aerococcus tenax ATCC TSD-302T. Microbiol Resour Announc. 2024 Jun 11;13(6):e0015624. doi: 10.1128/mra.00156-24. Epub 2024 Apr 23.
- Derived from this study: PubMed 33620895Hendrickson WK, Amundsen CL, Rahn DD, Meyer I, Bradley MS, Smith AL, Myers DL, Jelovsek JE, Lukacz ES. Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence. Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):140-146. doi: 10.1097/SPV.0000000000001020.
- Derived from this study: PubMed 27564385Visco AG, Zyczynski H, Brubaker L, Nygaard I, Xu X, Lukacz ES, Paraiso MF, Greer J, Rahn DD, Meikle SF, Honeycutt AA. Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):311-6. doi: 10.1097/SPV.0000000000000277.
- Derived from this study: PubMed 26516810Visco AG, Brubaker L, Jelovsek JE, Wilson TS, Norton P, Zyczynski HM, Spino C, Sirls L, Nguyen JN, Rahn DD, Meikle SF, Nolen TL; Pelvic Floor Disorders Network. Adherence to Oral Therapy for Urgency Urinary Incontinence: Results from the Anticholinergic Versus Botox Comparison (ABC) Trial. Female Pelvic Med Reconstr Surg. 2016 Jan-Feb;22(1):24-8. doi: 10.1097/SPV.0000000000000215.
- Derived from this study: PubMed 23036134Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012 Nov 8;367(19):1803-13. doi: 10.1056/NEJMoa1208872. Epub 2012 Oct 4.
- Derived from this study: PubMed 22008247Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Wei J, Chai T, Janz N, Spino C, Meikle S; Pelvic Floor Disorders Network. Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial. Contemp Clin Trials. 2012 Jan;33(1):184-96. doi: 10.1016/j.cct.2011.09.019. Epub 2011 Oct 8.
- 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.
Anthony Visco, MD study chair
Duke University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin A (Botox A®), Solifenacin 5mg and Solifenacin 10mg in people with Urge Urinary Incontinence and Overactive Bladder, run by NICHD Pelvic Floor Disorders Network at 11 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 8 inclusion and 27 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: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Urge Urinary Incontinence (UUI) Episodes (time frame: Baseline through 6 months). 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 NCT01166438, which also lists 6 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 2 May 2018.