<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/NCT04487600</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000902</org_study_id>
    <nct_id>NCT04487600</nct_id>
  </id_info>
  <brief_title>The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial</brief_title>
  <official_title>A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the impact of an active voiding trial compared to a&#xD;
      passive voiding trial on time to discharge following a planned same day discharge&#xD;
      laparoscopic hysterectomy. The investigators hypothesize that performing an active voiding&#xD;
      trial will assess urinary function and lead to a reduction in length of stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following laparoscopic surgery with hysterectomy, there is no standard method for assuring&#xD;
      urinary function prior to discharge. Total laparoscopic hysterectomy (TLH) has been&#xD;
      demonstrated to be safe with a reduction in post-operative morbidity and length of hospital&#xD;
      stay with no difference in cancer related outcomes in endometrial cancer. Furthermore, the&#xD;
      investigators have demonstrated that following the adoption of same day discharge, there was&#xD;
      no difference in composite complication rates or readmissions. Awaiting a passive void trial&#xD;
      may impact time to discharge as well as same day discharge; however, this has not been&#xD;
      clearly studied in this patient population. The aim of this study is to determine the&#xD;
      difference in time to discharge following an active voiding trial with bladder backfill in&#xD;
      the post-operative recovery unit compared to a passive voiding trial with removal of the&#xD;
      Foley catheter in the operating room at the end of the procedure. Secondary outcomes include&#xD;
      time to void, catheter replacement, discomfort with the voiding trial, and overnight&#xD;
      admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">August 4, 2017</completion_date>
  <primary_completion_date type="Actual">August 4, 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Patients who were scheduled to undergo a same day discharge laparoscopic hysterectomy were assessed for eligibility to participate in this study. A computer generated blocked randomization schema was utilized with alternating block sizes to determine study groups. Participants were randomized 1:1 to each study group (active voiding trial vs. passive voiding trial). There was no cross-over between arms. If the participant did not receive the study intervention as allocated they were withdrawn from the study.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Voiding trial protocols for each group (AVT and PVT) as well as data collection sheets were stored in sequentially numbered, opaque, sealed envelopes which were assigned after enrollment and were opened in the operating room at the completion of surgery by the surgical assistant. Attending surgeons and investigators were blinded to the individual patient study assignment. Due to the nature of the study, participants were not masked to their intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>within 24 hours (1440 minutes) following surgical procedure (while most participants are discharged on the same day some participants require overnight admission with length of stay up to 24 hours- though still measured in minutes)</time_frame>
    <description>Time (minutes) from the completion of surgery to discharge from the post-operative recovery unit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to void</measure>
    <time_frame>within 12 hours (720 minutes) following surgical procedure</time_frame>
    <description>Time (minutes) from Foley catheter removal to adequate voiding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>catheter replacement</measure>
    <time_frame>within 24 hours (1440 minutes) following surgical procedure</time_frame>
    <description>failed trial of void (unable to void adequate volume 2/3rd of backfill or 200cc) requiring replacement of a Foley catheter for post-operative urinary retention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>discomfort with voiding trial</measure>
    <time_frame>within 12 hours (720 minutes) following surgical procedure</time_frame>
    <description>average pain scale as measured by Wong-Baker FACES Pain Rating Scale ranging from 0 to 10 with 0 being no pain and 10 being the worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overnight admission</measure>
    <time_frame>within 1 day following surgical procedure</time_frame>
    <description>planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Minimally Invasive Surgical Procedure</condition>
  <condition>Hysterectomy</condition>
  <condition>Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Active Voiding Trial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the completion of surgery, a Foley catheter was left in place. When the patient was determined to be ambulatory by the recovery room nurse, the bladder was backfilled with 300cc of sterile normal saline. Voiding 200cc or (2/3) of the backfill amount was considered passing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passive Voiding Trial</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>At the completion of surgery, a Foley catheter was removed in the operating room. Study participants were allowed six hours to void spontaneously, with 200cc being considered adequate consistent with institution standard practice. At the completion of six hours, if spontaneous voiding has not occurred, a bladder scan was performed and additional time was allowed based on bladder volume with criteria previously established as institution standards based on published practices.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active voiding trial</intervention_name>
    <arm_group_label>Active Voiding Trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo a total laparoscopic hysterectomy by a gynecologic&#xD;
             oncology surgeon for either benign or malignant disease&#xD;
&#xD;
          -  planned same day discharge surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of significant urinary dysfunction (such as home catheterization) or&#xD;
             neurologic dysfunction precluding spontaneous voiding&#xD;
&#xD;
          -  bilateral radical pelvic dissection (defined as bilateral ureterolysis or removal of&#xD;
             bilateral parametria)&#xD;
&#xD;
          -  surgical cases converted to laparotomy or open surgery&#xD;
&#xD;
          -  Surgical or medical contra-indications (based on the surgeons or anesthesiologists'&#xD;
             recommendations) to same day discharge requiring inpatient admission&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Given the nature of the surgery (gynecologic oncology surgery with hysterectomy) the study is limited to female participants</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Lee J, Jennings K, Borahay MA, Rodriguez AM, Kilic GS, Snyder RR, Patel PR. Trends in the national distribution of laparoscopic hysterectomies from 2003 to 2010. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):656-61. doi: 10.1016/j.jmig.2014.01.012. Epub 2014 Jan 24.</citation>
    <PMID>24462854</PMID>
  </reference>
  <reference>
    <citation>Pitter MC, Simmonds C, Seshadri-Kreaden U, Hubert HB. The impact of different surgical modalities for hysterectomy on satisfaction and patient reported outcomes. Interact J Med Res. 2014 Jul 17;3(3):e11. doi: 10.2196/ijmr.3160.</citation>
    <PMID>25048103</PMID>
  </reference>
  <reference>
    <citation>Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.</citation>
    <PMID>23107080</PMID>
  </reference>
  <reference>
    <citation>Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.</citation>
    <PMID>19805679</PMID>
  </reference>
  <reference>
    <citation>Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Barakat R, Pearl ML, Sharma SK. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012 Mar 1;30(7):695-700. doi: 10.1200/JCO.2011.38.8645. Epub 2012 Jan 30. Erratum In: J Clin Oncol. 2012 May 1;30(13):1570.</citation>
    <PMID>22291074</PMID>
  </reference>
  <reference>
    <citation>Melamed A, Katz Eriksen JL, Hinchcliff EM, et al. Same-day discharge after laparoscopic hysterectomy for endometrial cancer. Gynecol Oncol. 2015;137(January 2015):37-38. doi:10.1016/j.ygyno.2015.01.088</citation>
  </reference>
  <reference>
    <citation>Nahas S, Feigenberg T, Park S. Feasibility and safety of same-day discharge after minimally invasive hysterectomy in gynecologic oncology: A systematic review of the literature. Gynecol Oncol. 2016 Nov;143(2):439-442. doi: 10.1016/j.ygyno.2016.07.113. Epub 2016 Jul 27.</citation>
    <PMID>27475523</PMID>
  </reference>
  <reference>
    <citation>Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014.</citation>
    <PMID>25210477</PMID>
  </reference>
  <reference>
    <citation>Foundation W-BF. Wong-Baker FACES® Pain Rating Scale. 2016</citation>
  </reference>
  <reference>
    <citation>Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.</citation>
    <PMID>3558716</PMID>
  </reference>
  <results_reference>
    <citation>Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.</citation>
    <PMID>17980330</PMID>
  </results_reference>
  <results_reference>
    <citation>Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.</citation>
    <PMID>21860294</PMID>
  </results_reference>
  <results_reference>
    <citation>Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.</citation>
    <PMID>18060956</PMID>
  </results_reference>
  <results_reference>
    <citation>Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.</citation>
    <PMID>20727543</PMID>
  </results_reference>
  <results_reference>
    <citation>Alessandri F, Mistrangelo E, Lijoi D, Ferrero S, Ragni N. A prospective, randomized trial comparing immediate versus delayed catheter removal following hysterectomy. Acta Obstet Gynecol Scand. 2006;85(6):716-20. doi: 10.1080/00016340600606976.</citation>
    <PMID>16752265</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Colleen Marie Feltmate, MD</investigator_full_name>
    <investigator_title>BWPO Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified patient data and voiding protocols will be made available upon request via email to other researchers</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available upon request until the time of publication.</ipd_time_frame>
    <ipd_access_criteria>requests should be made via the study contact email.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04487600
org study id: 2015P000902
nct id: NCT04487600
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the impact of an active voiding trial compared to a
      passive voiding trial on time to discharge following a planned same day discharge
      laparoscopic hysterectomy. The investigators hypothesize that performing an active voiding
      trial will assess urinary function and lead to a reduction in length of stay.
Following laparoscopic surgery with hysterectomy, there is no standard method for assuring
      urinary function prior to discharge. Total laparoscopic hysterectomy (TLH) has been
      demonstrated to be safe with a reduction in post-operative morbidity and length of hospital
      stay with no difference in cancer related outcomes in endometrial cancer. Furthermore, the
      investigators have demonstrated that following the adoption of same day discharge, there was
      no difference in composite complication rates or readmissions. Awaiting a passive void trial
      may impact time to discharge as well as same day discharge; however, this has not been
      clearly studied in this patient population. The aim of this study is to determine the
      difference in time to discharge following an active voiding trial with bladder backfill in
      the post-operative recovery unit compared to a passive voiding trial with removal of the
      Foley catheter in the operating room at the end of the procedure. Secondary outcomes include
      time to void, catheter replacement, discomfort with the voiding trial, and overnight
      admission.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients who were scheduled to undergo a same day discharge laparoscopic hysterectomy were assessed for eligibility to participate in this study. A computer generated blocked randomization schema was utilized with alternating block sizes to determine study groups. Participants were randomized 1:1 to each study group (active voiding trial vs. passive voiding trial). There was no cross-over between arms. If the participant did not receive the study intervention as allocated they were withdrawn from the study.
primary purpose: Supportive Care
masking: Single (Investigator)
masking description: Voiding trial protocols for each group (AVT and PVT) as well as data collection sheets were stored in sequentially numbered, opaque, sealed envelopes which were assigned after enrollment and were opened in the operating room at the completion of surgery by the surgical assistant. Attending surgeons and investigators were blinded to the individual patient study assignment. Due to the nature of the study, participants were not masked to their intervention.
measure: length of hospital stay
time frame: within 24 hours (1440 minutes) following surgical procedure (while most participants are discharged on the same day some participants require overnight admission with length of stay up to 24 hours- though still measured in minutes)
description: Time (minutes) from the completion of surgery to discharge from the post-operative recovery unit
measure: time to void
time frame: within 12 hours (720 minutes) following surgical procedure
description: Time (minutes) from Foley catheter removal to adequate voiding
measure: catheter replacement
time frame: within 24 hours (1440 minutes) following surgical procedure
description: failed trial of void (unable to void adequate volume 2/3rd of backfill or 200cc) requiring replacement of a Foley catheter for post-operative urinary retention
measure: discomfort with voiding trial
time frame: within 12 hours (720 minutes) following surgical procedure
description: average pain scale as measured by Wong-Baker FACES Pain Rating Scale ranging from 0 to 10 with 0 being no pain and 10 being the worst pain.
measure: overnight admission
time frame: within 1 day following surgical procedure
description: planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)
arm group label: Active Voiding Trial
arm group type: Experimental
description: At the completion of surgery, a Foley catheter was left in place. When the patient was determined to be ambulatory by the recovery room nurse, the bladder was backfilled with 300cc of sterile normal saline. Voiding 200cc or (2/3) of the backfill amount was considered passing.
arm group label: Passive Voiding Trial
arm group type: No Intervention
description: At the completion of surgery, a Foley catheter was removed in the operating room. Study participants were allowed six hours to void spontaneously, with 200cc being considered adequate consistent with institution standard practice. At the completion of six hours, if spontaneous voiding has not occurred, a bladder scan was performed and additional time was allowed based on bladder volume with criteria previously established as institution standards based on published practices.
intervention type: Other
intervention name: Active voiding trial
arm group label: Active Voiding Trial
criteria: 
gender: Female
gender based: Yes
gender description: Given the nature of the surgery (gynecologic oncology surgery with hysterectomy) the study is limited to female participants
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Lee J, Jennings K, Borahay MA, Rodriguez AM, Kilic GS, Snyder RR, Patel PR. Trends in the national distribution of laparoscopic hysterectomies from 2003 to 2010. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):656-61. doi: 10.1016/j.jmig.2014.01.012. Epub 2014 Jan 24.
PMID: 24462854
citation: Pitter MC, Simmonds C, Seshadri-Kreaden U, Hubert HB. The impact of different surgical modalities for hysterectomy on satisfaction and patient reported outcomes. Interact J Med Res. 2014 Jul 17;3(3):e11. doi: 10.2196/ijmr.3160.
PMID: 25048103
citation: Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.
PMID: 23107080
citation: Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.
PMID: 19805679
citation: Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Barakat R, Pearl ML, Sharma SK. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012 Mar 1;30(7):695-700. doi: 10.1200/JCO.2011.38.8645. Epub 2012 Jan 30. Erratum In: J Clin Oncol. 2012 May 1;30(13):1570.
PMID: 22291074
citation: Melamed A, Katz Eriksen JL, Hinchcliff EM, et al. Same-day discharge after laparoscopic hysterectomy for endometrial cancer. Gynecol Oncol. 2015;137(January 2015):37-38. doi:10.1016/j.ygyno.2015.01.088
citation: Nahas S, Feigenberg T, Park S. Feasibility and safety of same-day discharge after minimally invasive hysterectomy in gynecologic oncology: A systematic review of the literature. Gynecol Oncol. 2016 Nov;143(2):439-442. doi: 10.1016/j.ygyno.2016.07.113. Epub 2016 Jul 27.
PMID: 27475523
citation: Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014.
PMID: 25210477
citation: Foundation W-BF. Wong-Baker FACES® Pain Rating Scale. 2016
citation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PMID: 3558716
citation: Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.
PMID: 17980330
citation: Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
PMID: 21860294
citation: Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
PMID: 18060956
citation: Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.
PMID: 20727543
citation: Alessandri F, Mistrangelo E, Lijoi D, Ferrero S, Ragni N. A prospective, randomized trial comparing immediate versus delayed catheter removal following hysterectomy. Acta Obstet Gynecol Scand. 2006;85(6):716-20. doi: 10.1080/00016340600606976.
PMID: 16752265
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Colleen Marie Feltmate, MD
investigator title: BWPO Physician
mesh term: Urinary Retention
sharing ipd: Yes
ipd description: De-identified patient data and voiding protocols will be made available upon request via email to other researchers
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available upon request until the time of publication.
ipd access criteria: requests should be made via the study contact email.