xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06034288</url>
    </required_header>
    <id_info>
      <org_study_id>WRNMMC-2022-0398</org_study_id>
      <nct_id>NCT06034288</nct_id>
    </id_info>
    <brief_title>Xeomin vs Botox for Treatment of Overactive Bladder Syndrome</brief_title>
    <official_title>IncobotulinumtoxinA (Xeomin®) vs OnabotulimuntoxinA (Botox®) for Treatment of Overactive Bladder Syndrome: Randomized Non-Inferiority Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Walter Reed National Military Medical Center</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Walter Reed National Military Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Purpose: Multiple formulations and brands of botulinum toxin exist on the market today. Only&#xD;
        OnabotulinumtoxinA (BOTOX®) is currently FDA approved for treatment of overactive bladder.&#xD;
        IncobotulinumtoxinA (XEOMIN®) is a similar formulation of botulinum toxin A that has similar&#xD;
        dosing and safety profile at onabotulinumtoxinA. OnabotulinumtoxinA is the most expensive&#xD;
        formulation on the market. Compare the efficacy of incobotulinumtoxinA (Xeomin®, Merz&#xD;
        Pharmaceuticals) to onabotulinumtoxinA (Botox®, Allergan) for treatment of OAB. Study design:&#xD;
        A single-blinded, randomized non-inferiority trial of IncobotulinumtoxinA (Xeomin®, Merz&#xD;
        Pharmaceuticals) to OnabotulinumtoxinA (Botox®, Allergan) in treatment of OAB. Target&#xD;
        Population: The study findings will be applicable to all women 18 years of age or older with&#xD;
        OAB symptoms associated with urinary urgency incontinence. Procedure: All patients that&#xD;
        presents to urogynecology clinic at Walter Reed National Medical Military Center will be&#xD;
        screened for inclusion and exclusion criteria. Patients that meet criteria will be offered to&#xD;
        participate in the study. After enrollment patient will complete demographics data sheet, 24&#xD;
        hours bladder diary, OAB-q SF, PGI-S, PISQ-IR. Patients will be randomized by the principal&#xD;
        investigator and the allocated treatment will be reveled by the treating provider to the&#xD;
        treating provider only. Patient will have a follow up at 2-6 weeks and 6-9 months after&#xD;
        procedure. During the follow up appointments patient will be asked to fill out 24-hour&#xD;
        voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be registered on clinicaltrials.gov after IRB approval. Institutional Review&#xD;
        Board (IRB) approval will be received.&#xD;
  &#xD;
        All women 18 years of age and older with bothersome overactive bladder symptoms who are&#xD;
        receiving care at Walter Reed National Military Medical Center (WRNMMC) in the urogynecology&#xD;
        clinic will be eligible for the study.&#xD;
  &#xD;
        All study participants will undergo a complete intake assessment to include a history,&#xD;
        physical exam, post-void bladder residual volume assessment via straight catheterization or&#xD;
        ultrasound, and counseling on treatment modalities for OAB using the AUGS handout to include&#xD;
        behavioral and dietary modifications, physical therapy, oral medications, onabotulinumtoxinA&#xD;
        and neuromodulation. Patients desiring treatment with onabotulinumtoxinA will be scheduled&#xD;
        for the procedure. Patients do not have to fail prior treatment options in order to qualify&#xD;
        for bladder BOTOX. This is all standard of care in our practice. All patients meeting the&#xD;
        inclusion and exclusion criteria will be offered enrollment in this study. Enrollment will be&#xD;
        done by the research team, who typically are also the clinicians. No patients will be&#xD;
        pressured or coerced into participating in the study.&#xD;
  &#xD;
        Prior to the procedure appointment, participants will be consented for participation in the&#xD;
        study and asked to complete demographics data sheet, 24 hours bladder diary, OAB-q SF, PGI-S,&#xD;
        PISQ-IR. OAB-q SF is a standard of are in our practice, all other questionnaires patient will&#xD;
        fill out for the purpose of this study.&#xD;
  &#xD;
        The procedure will be performed at Walter Reed National Military Medical Center either in&#xD;
        clinic setting or in the operating room. All patients who plan to undergo the procedure in&#xD;
        clinic will be offered a pre-treatment anxiolytic with a single dose of 5-10mg of oral&#xD;
        diazepam, which is standard practice at this institution. Patients undergoing the procedure&#xD;
        in the operating room, will be given sedation medications as per standard of care. As&#xD;
        standard of treatment, patients will also be given a prescription for an antibiotic - either&#xD;
        nitrofurantoin 100mg to take orally twice daily for 3 days starting the day of the procedure,&#xD;
        or trimethoprim-sulfamethoxazole 800mg-160mg to take orally twice daily for 3 days starting&#xD;
        the day of the procedure depending on patient's allergy profile.&#xD;
  &#xD;
        The principal investigator will make randomized assignments using the RAND function in excel.&#xD;
        The first 32 random numbers will be assigned to BOTOX arm and the second 32 numbers will be&#xD;
        assigned to XEOMIN arm. Each assignment number will be placed in a sealed envelop by the PI.&#xD;
        The sealed envelops will be opened by the treatment provider the day of the scheduled&#xD;
        procedure. The envelop will reveal the medication assignment to the provider. After the&#xD;
        provider reveals the medication only to him/herself (not the patient), the appropriate&#xD;
        medication will be obtained from the pharmacy and administered to the patient.&#xD;
  &#xD;
        The patient will be blinded to the treatment allocation. The drug will be obtained from the&#xD;
        pharmacy on the day of the procedure by the treatment team. Either onabotulinumtoxinA or&#xD;
        incobotulinumtoxinA (as determined by the allocated assignment), will be reconstituted in 10&#xD;
        milliliters of injectable saline by the treatment team prior to entering the patient's room,&#xD;
        to keep the patient blinded. The bladder will be filled with 20ml of 2% viscous lidocaine&#xD;
        through the urethra 15 to 20 minutes prior to the procedure per the Urogynecology department&#xD;
        standard operating procedure for intradetrusor onabotulinumtoxinA injections. Operative&#xD;
        cystoscopy will be performed, and an adjustable-depth injection cystoscopy needle will be&#xD;
        used to inject the blinded study drug (either 100 units of onabotulinumtoxinA (Botox®,&#xD;
        Allergan) or 100 units of incobotulinumtoxinA (Xeomin®, Merz Pharmaceutical)) with the needle&#xD;
        depth set to 3mm. Injections will be performed by either a board-certified staff&#xD;
        Urogynecologist, or fellows or residents working under their direct supervision of the&#xD;
        board-certified staff urogynecologist. An injection cystoscopy needle will be set to 3mm and&#xD;
        used to inject 0.5mL reconstituted study medication at each injection site, approximately 1cm&#xD;
        apart along the posterior bladder wall making sure to avoid the trigone, for a total or 20&#xD;
        injection sites (4 rows of 5 injection sites). After the completion of the procedure,&#xD;
        patients will be asked to start taking their prescribed antibiotics and to continue them for&#xD;
        3 days.&#xD;
  &#xD;
        If a known UTI was inadequately treated prior to procedure appointment, or if there is&#xD;
        evidence of an active infection at the time of cystoscopy, the intravesical injection will&#xD;
        not be completed and patient will be rescheduled.&#xD;
  &#xD;
        Participants will have a follow-up appointment in 2-6 weeks following the procedure in&#xD;
        person, via phone or email. At the follow-up visit patients will be asked to complete a&#xD;
        24-hour bladder diary, OAB-q SF, PGI-I, PGI-S, PISQ-IR surveys. The surveys will either be&#xD;
        read or emailed to the patient based on patient's preference. Patients will be asked&#xD;
        regarding urinary tract infection (UTI) symptoms and whether they needed clean intermittent&#xD;
        catheterization (CIC). The electronic health record (EHR) will also be reviewed to confirm&#xD;
        whether UTI has occurred or if CIC needed to be done. Patients will be asked whether they are&#xD;
        experiencing painful urination, urinary frequency, urinary urgency, or blood in their urine.&#xD;
        If patients answer yes to any of those questions, they will be asked to provide a urine&#xD;
        sample. If this follow up is being done in person, then a urine sample will be obtained via&#xD;
        straight catheterization during the appointment. If the follow up visit is being done&#xD;
        virtually, patient will be asked to come into clinic or laboratory and provide a urine sample&#xD;
        via straight catheterization or clean catch for urinalysis and urine culture to assess for&#xD;
        UTI. If infection is present, patients will receive appropriate antibiotics based on culture&#xD;
        sensitivities. Patients found to have an active infection at the time of postprocedural&#xD;
        follow-up will be asked to complete the study questionnaires 2-4 weeks following treatment of&#xD;
        infection. Patients will also be asked if they experienced any other symptoms following the&#xD;
        procedure that concerned them and any symptoms reported will be recorded.&#xD;
  &#xD;
        Participants who experience initial relief in their symptoms following injection of the study&#xD;
        medication but then experience recurrence of symptoms will be eligible for repeat injection&#xD;
        provided it has been at least 12 weeks from prior injection and the total dose of&#xD;
        onabotulinumtoxinA/incobotulinumtoxinA does not exceed 400 units in a three-month time frame,&#xD;
        as is standard of care.&#xD;
  &#xD;
        Six to nine months following the treatment, patients will be contacted via phone or email and&#xD;
        asked to complete a 24-hour voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys for&#xD;
        final assessment of symptoms following treatment. They will again be asked regarding adverse&#xD;
        events. The questionnaires again will either be read to the patient via phone or emailed&#xD;
        based on patient's preference.&#xD;
  &#xD;
        This research study is a single-blind study. Unblinding of subjects will be performed at the&#xD;
        conclusion of the study after enrollment is closed and data collection is complete.&#xD;
        Participants will not be notified of their group assignment unless it is requested after the&#xD;
        completion of the final follow up encounter. If the participant would like to know their&#xD;
        group assignment, they will contact the PI who will release that information to them after&#xD;
        the conclusion of the study. Study participants who request to be un-blinded as to their&#xD;
        randomized assigned group early will need to be withdrawn from the study. The participant&#xD;
        will supply a request in writing to the PI. Any data regarding that participant will be&#xD;
        removed from the records and that assignment number will be noted as withdrawn. A memorandum&#xD;
        for record will be created outlining the subject's request and both the MFR and subject's&#xD;
        written request will be maintained with the data collection for reference. In the event of an&#xD;
        emergency, there is a way to find out which one you are receiving. If there is a medical&#xD;
        emergency that may require unblinding prior to the conclusion of the study, the research team&#xD;
        will work in coordination with the subject's primary care or emergency provider to determine&#xD;
        if unblinding is necessary and make that information available to them as needed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 4, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Urge urinary incontinence episodes</measure>
      <time_frame>2-6 weeks</time_frame>
      <description>To evaluate non-inferiority of incobotulinumtoxinA to onabotulinumtoxinA for treatment of OAB by using number of incontinence episodes on a 24-hours bladder diary at 2-6 weeks post injection</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Overactive Bladder Syndrome</condition>
    <arm_group>
      <arm_group_label>Xeomin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>100units xeomin dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Botox</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>100units Botox dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Xeomin 100 UNT Injection</intervention_name>
      <description>intravesical injection</description>
      <arm_group_label>Xeomin</arm_group_label>
      <other_name>incobotulinumtoxinA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Botox 100 UNT Injection</intervention_name>
      <description>intravesical injection</description>
      <arm_group_label>Botox</arm_group_label>
      <other_name>onabotulinumtoxinA</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Females 18 years of age or older&#xD;
  &#xD;
            2. Primary complaint of urinary urgency incontinence&#xD;
  &#xD;
            3. Failed at least one medication (inadequate or poorly tolerated response) or behavior&#xD;
               modification technique (timed voiding, pelvic floor physical therapy, dietary&#xD;
               modifications, etc.), or decline such interventions&#xD;
  &#xD;
            4. Willingness to perform self-catheterization&#xD;
  &#xD;
            5. Ability to follow study instructions and complete all required follow-up&#xD;
  &#xD;
            6. DEERS eligible&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3&#xD;
               agonists)&#xD;
  &#xD;
            2. Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin&#xD;
  &#xD;
            3. Post void residual volume &gt; 200 ml&#xD;
  &#xD;
            4. Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or&#xD;
               greater that is untreated&#xD;
  &#xD;
            5. Evidence of active bladder infection&#xD;
  &#xD;
            6. Any previous use of intradetrusor botulinum toxin within the preceding 6 months&#xD;
  &#xD;
            7. Total body onabotulinumtoxinA and/or incobotulinumtoxinA dose of ≥ 400 Units in the 3&#xD;
               months prior to scheduled appointment&#xD;
  &#xD;
            8. Procedure performed in the main operating room (not outpatient setting)&#xD;
  &#xD;
            9. Concurrent diagnosis of interstitial cystitis/painful bladder syndrome&#xD;
  &#xD;
           10. Females who are pregnant or planning a pregnancy during the study or who think that&#xD;
               they may be pregnant at the start of the study, or females of childbearing potential&#xD;
               who are unable or unwilling to use a reliable form of contraception during the study&#xD;
  &#xD;
           11. Neurogenic bladder or other neurological disease that may cause voiding dysfunction&#xD;
  &#xD;
           12. Inability to speak or read English. Non-English speakers will be excluded from this&#xD;
               study for ease of being able to allow the principal investigator to communicate with&#xD;
               the patients during the consents, initial and all follow-up communication. Some of the&#xD;
               questionnaires used have also only been validated in English.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anna S Trikhacheva, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Walter Reed Army Institute of Research (WRAIR)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anna S Trikhacheva, MD</last_name>
      <phone>7162353843</phone>
      <email>ann_trik@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Walter Reed National Military Medical Center</name>
        <address>
          <city>Bethesda</city>
          <state>Maryland</state>
          <zip>20889</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>anna trikhacheva, md</last_name>
        <phone>716-235-3843</phone>
      </contact>
      <contact_backup>
        <last_name>christine vaccaro, md</last_name>
        <phone>3014002469</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder, Overactive</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Botulinum Toxins, Type A</mesh_term>
      <mesh_term>incobotulinumtoxinA</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06034288
  org study id: WRNMMC-2022-0398
  nct id: NCT06034288
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Purpose: Multiple formulations and brands of botulinum toxin exist on the market today. Only
        OnabotulinumtoxinA (BOTOX®) is currently FDA approved for treatment of overactive bladder.
        IncobotulinumtoxinA (XEOMIN®) is a similar formulation of botulinum toxin A that has similar
        dosing and safety profile at onabotulinumtoxinA. OnabotulinumtoxinA is the most expensive
        formulation on the market. Compare the efficacy of incobotulinumtoxinA (Xeomin®, Merz
        Pharmaceuticals) to onabotulinumtoxinA (Botox®, Allergan) for treatment of OAB. Study design:
        A single-blinded, randomized non-inferiority trial of IncobotulinumtoxinA (Xeomin®, Merz
        Pharmaceuticals) to OnabotulinumtoxinA (Botox®, Allergan) in treatment of OAB. Target
        Population: The study findings will be applicable to all women 18 years of age or older with
        OAB symptoms associated with urinary urgency incontinence. Procedure: All patients that
        presents to urogynecology clinic at Walter Reed National Medical Military Center will be
        screened for inclusion and exclusion criteria. Patients that meet criteria will be offered to
        participate in the study. After enrollment patient will complete demographics data sheet, 24
        hours bladder diary, OAB-q SF, PGI-S, PISQ-IR. Patients will be randomized by the principal
        investigator and the allocated treatment will be reveled by the treating provider to the
        treating provider only. Patient will have a follow up at 2-6 weeks and 6-9 months after
        procedure. During the follow up appointments patient will be asked to fill out 24-hour
        voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys.
  The study will be registered on clinicaltrials.gov after IRB approval. Institutional Review
        Board (IRB) approval will be received.
  
        All women 18 years of age and older with bothersome overactive bladder symptoms who are
        receiving care at Walter Reed National Military Medical Center (WRNMMC) in the urogynecology
        clinic will be eligible for the study.
  
        All study participants will undergo a complete intake assessment to include a history,
        physical exam, post-void bladder residual volume assessment via straight catheterization or
        ultrasound, and counseling on treatment modalities for OAB using the AUGS handout to include
        behavioral and dietary modifications, physical therapy, oral medications, onabotulinumtoxinA
        and neuromodulation. Patients desiring treatment with onabotulinumtoxinA will be scheduled
        for the procedure. Patients do not have to fail prior treatment options in order to qualify
        for bladder BOTOX. This is all standard of care in our practice. All patients meeting the
        inclusion and exclusion criteria will be offered enrollment in this study. Enrollment will be
        done by the research team, who typically are also the clinicians. No patients will be
        pressured or coerced into participating in the study.
  
        Prior to the procedure appointment, participants will be consented for participation in the
        study and asked to complete demographics data sheet, 24 hours bladder diary, OAB-q SF, PGI-S,
        PISQ-IR. OAB-q SF is a standard of are in our practice, all other questionnaires patient will
        fill out for the purpose of this study.
  
        The procedure will be performed at Walter Reed National Military Medical Center either in
        clinic setting or in the operating room. All patients who plan to undergo the procedure in
        clinic will be offered a pre-treatment anxiolytic with a single dose of 5-10mg of oral
        diazepam, which is standard practice at this institution. Patients undergoing the procedure
        in the operating room, will be given sedation medications as per standard of care. As
        standard of treatment, patients will also be given a prescription for an antibiotic - either
        nitrofurantoin 100mg to take orally twice daily for 3 days starting the day of the procedure,
        or trimethoprim-sulfamethoxazole 800mg-160mg to take orally twice daily for 3 days starting
        the day of the procedure depending on patient's allergy profile.
  
        The principal investigator will make randomized assignments using the RAND function in excel.
        The first 32 random numbers will be assigned to BOTOX arm and the second 32 numbers will be
        assigned to XEOMIN arm. Each assignment number will be placed in a sealed envelop by the PI.
        The sealed envelops will be opened by the treatment provider the day of the scheduled
        procedure. The envelop will reveal the medication assignment to the provider. After the
        provider reveals the medication only to him/herself (not the patient), the appropriate
        medication will be obtained from the pharmacy and administered to the patient.
  
        The patient will be blinded to the treatment allocation. The drug will be obtained from the
        pharmacy on the day of the procedure by the treatment team. Either onabotulinumtoxinA or
        incobotulinumtoxinA (as determined by the allocated assignment), will be reconstituted in 10
        milliliters of injectable saline by the treatment team prior to entering the patient's room,
        to keep the patient blinded. The bladder will be filled with 20ml of 2% viscous lidocaine
        through the urethra 15 to 20 minutes prior to the procedure per the Urogynecology department
        standard operating procedure for intradetrusor onabotulinumtoxinA injections. Operative
        cystoscopy will be performed, and an adjustable-depth injection cystoscopy needle will be
        used to inject the blinded study drug (either 100 units of onabotulinumtoxinA (Botox®,
        Allergan) or 100 units of incobotulinumtoxinA (Xeomin®, Merz Pharmaceutical)) with the needle
        depth set to 3mm. Injections will be performed by either a board-certified staff
        Urogynecologist, or fellows or residents working under their direct supervision of the
        board-certified staff urogynecologist. An injection cystoscopy needle will be set to 3mm and
        used to inject 0.5mL reconstituted study medication at each injection site, approximately 1cm
        apart along the posterior bladder wall making sure to avoid the trigone, for a total or 20
        injection sites (4 rows of 5 injection sites). After the completion of the procedure,
        patients will be asked to start taking their prescribed antibiotics and to continue them for
        3 days.
  
        If a known UTI was inadequately treated prior to procedure appointment, or if there is
        evidence of an active infection at the time of cystoscopy, the intravesical injection will
        not be completed and patient will be rescheduled.
  
        Participants will have a follow-up appointment in 2-6 weeks following the procedure in
        person, via phone or email. At the follow-up visit patients will be asked to complete a
        24-hour bladder diary, OAB-q SF, PGI-I, PGI-S, PISQ-IR surveys. The surveys will either be
        read or emailed to the patient based on patient's preference. Patients will be asked
        regarding urinary tract infection (UTI) symptoms and whether they needed clean intermittent
        catheterization (CIC). The electronic health record (EHR) will also be reviewed to confirm
        whether UTI has occurred or if CIC needed to be done. Patients will be asked whether they are
        experiencing painful urination, urinary frequency, urinary urgency, or blood in their urine.
        If patients answer yes to any of those questions, they will be asked to provide a urine
        sample. If this follow up is being done in person, then a urine sample will be obtained via
        straight catheterization during the appointment. If the follow up visit is being done
        virtually, patient will be asked to come into clinic or laboratory and provide a urine sample
        via straight catheterization or clean catch for urinalysis and urine culture to assess for
        UTI. If infection is present, patients will receive appropriate antibiotics based on culture
        sensitivities. Patients found to have an active infection at the time of postprocedural
        follow-up will be asked to complete the study questionnaires 2-4 weeks following treatment of
        infection. Patients will also be asked if they experienced any other symptoms following the
        procedure that concerned them and any symptoms reported will be recorded.
  
        Participants who experience initial relief in their symptoms following injection of the study
        medication but then experience recurrence of symptoms will be eligible for repeat injection
        provided it has been at least 12 weeks from prior injection and the total dose of
        onabotulinumtoxinA/incobotulinumtoxinA does not exceed 400 units in a three-month time frame,
        as is standard of care.
  
        Six to nine months following the treatment, patients will be contacted via phone or email and
        asked to complete a 24-hour voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys for
        final assessment of symptoms following treatment. They will again be asked regarding adverse
        events. The questionnaires again will either be read to the patient via phone or emailed
        based on patient's preference.
  
        This research study is a single-blind study. Unblinding of subjects will be performed at the
        conclusion of the study after enrollment is closed and data collection is complete.
        Participants will not be notified of their group assignment unless it is requested after the
        completion of the final follow up encounter. If the participant would like to know their
        group assignment, they will contact the PI who will release that information to them after
        the conclusion of the study. Study participants who request to be un-blinded as to their
        randomized assigned group early will need to be withdrawn from the study. The participant
        will supply a request in writing to the PI. Any data regarding that participant will be
        removed from the records and that assignment number will be noted as withdrawn. A memorandum
        for record will be created outlining the subject's request and both the MFR and subject's
        written request will be maintained with the data collection for reference. In the event of an
        emergency, there is a way to find out which one you are receiving. If there is a medical
        emergency that may require unblinding prior to the conclusion of the study, the research team
        will work in coordination with the subject's primary care or emergency provider to determine
        if unblinding is necessary and make that information available to them as needed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Urge urinary incontinence episodes
  time frame: 2-6 weeks
  description: To evaluate non-inferiority of incobotulinumtoxinA to onabotulinumtoxinA for treatment of OAB by using number of incontinence episodes on a 24-hours bladder diary at 2-6 weeks post injection
  arm group label: Xeomin
  arm group type: Experimental
  description: 100units xeomin dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each
  arm group label: Botox
  arm group type: Active Comparator
  description: 100units Botox dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each
  intervention type: Drug
  intervention name: Xeomin 100 UNT Injection
  description: intravesical injection
  arm group label: Xeomin
  other name: incobotulinumtoxinA
  intervention type: Drug
  intervention name: Botox 100 UNT Injection
  description: intravesical injection
  arm group label: Botox
  other name: onabotulinumtoxinA
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anna S Trikhacheva, MD
  role: Principal Investigator
  affiliation: Walter Reed Army Institute of Research (WRAIR)
  last name: Anna S Trikhacheva, MD
  phone: 7162353843
  email: ann_trik@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Urinary Bladder, Overactive
  mesh term: Syndrome
  mesh term: Botulinum Toxins, Type A
  mesh term: incobotulinumtoxinA
  sharing ipd: No