Lower Urinary Tract SymptomsPhase 2HILUTSNCT03633994
Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy
A Phase 2 study testing Heparin and Normal saline in people with Lower Urinary Tract Symptoms and Postoperative Urinary Tract Infection, run by The Christ Hospital at 1 site in United States.
Trial summary
This study will explore the application of placing heparin into the bladder via a catheter to decrease postoperative lower urinary tract symptoms (LUTS) and urinary tract infection (UTI) symptoms such as urinary frequency, urinary urgency, pain with urination, or difficulty voiding following hysterectomy (surgically… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Postoperative Urinary Tract Infection
- What is being tested?
- Heparin and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 1 Mar 2020
- Phase
- Phase 2
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85-years old
- scheduled to undergo a benign hysterectomy
Who cannot join
- non-English speakers
- current use of anticoagulants or thrombolytic agents
- known adverse reaction or hypersensitivity to heparin
- history of or active genitourinary tract cancer (bladder, uterine, cervical, ovarian or vaginal)
- history of neurogenic bladder
- pelvic irradiation
Show all 10Show fewer
- chemical cystitis
- pregnancy
- antibiotic use within the past 30 days
- Surgical procedures involving: anterior or posterior colporrhaphy, vaginal mesh excision, fistula repair, diverticulum repair, urethral reconstruction, planned or incidental cystotomy
Trial locations and contacts
1 site in 1 country.
James Whiteside, MD contact
United States1 site, 1 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Hoi Tik H Yuen, MD, 513-463-2500, hoitik.yuen@thechristhospital.com
James L Whiteside, MD, whitesje@ucmail.uc.edu
About this study
Official title: Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy: A Randomized Controlled Trial
This study will explore the application of placing heparin into the bladder via a catheter to decrease postoperative lower urinary tract symptoms (LUTS) and urinary tract infection (UTI) symptoms such as urinary frequency, urinary urgency, pain with urination, or difficulty voiding following hysterectomy (surgically removing the uterus). The investigators hypothesize that heparin bladder instillations will reduce LUTS, UTI symptoms, and improve patient satisfaction following hysterectomy.
Read the detailed description
Data Collection
Subject demographics and history information will be obtained from The Christ Hospital Medical Center's electronic medical record. In addition, preoperative diagnosis, postoperative diagnosis, procedure performed, total operative time, estimated blood loss, intraoperative complications, anterior prolapse repair, use of cystoscopy, preoperative urinalysis, postoperative complications, uterine size, and any urine cultures collected within the 2 week postoperative period will also obtained from the electronic medical record.
The post-operative lower urinary tract symptoms assessments will be collected, the paper records will be secured in a locker labeled with the study identification number, which will then be entered into EXCEL on a password secured database and the paper copy will be disposed of in the secure destruction station.
Descriptive Analysis
Simple statistics and demographics will be done across the two cohorts. Categorical variables will be analyzed using Chi-square while continuous variables (e.g. UTISA scores) will be analyzed using t-test so long as the distribution of the data are normal. Additional analyzes as appropriate will be done to identify group differences based on patient demographics (e.g. age, concomitant procedures, surgeon, estrogen use, foley catheter placement, etc).
Data Analysis and Data Monitoring
The UTISA survey and VAS pain scale both result a continuous variable that between the two cohorts will be compared using a t-Test provided the results distribution is normal. Antibiotic use or self-reported UTI rates are nominal variables that across the cohorts would be compared using a X2.
Data analysis will be performed using statistical software (JMP 13.2.0, SAS Institute Inc., Cary NC, USA). The data will be assembled into a password protected EXCEL (Microsoft, Redmond WA, USA) spreadsheet. A separate password protected spreadsheet will link the study ID and the enrolled patient's MRN. Analysis would be done only on the de-identified data.
Data Storage and Confidentiality
Study data will be managed in a password-protected EXCEL (Microsoft, Redmond WA, USA) spreadsheet on a password-protected computer. A separate password protected spreadsheet linking the study ID and MRN will be kept on a separate password-protected secure drive. This "key" file will be securely destroyed when the data has been fully analyzed. Paper records including consent will be in a locked research drawer, in the designated locked office. The investigators will dispose of any paper documents after data has been analyzed using the CINTAS Secure Destruction Station.
Sample Size
The symptom with the highest sensitivity and specificity to predict a UTI is dysuria. A study in 2013 demonstrated a 50% reduction in UTIs among heparin treated patients, the investigators estimated an effect size of 0.6, assuming mean UTISA dysuria scores of 2 and 1 among the untreated and treated cohorts assessed on post-operative day 1. Assuming an α of 0.05 and 80% power, the investigators estimate requiring 45 subjects per study arm totaling 90 patients. Assuming at least 15% attrition in each arm, the investigators estimate needing to enroll at least 52 patients per study arm to a total of 104 patients.
Plans for recruitment of subjects
No advertisement will be used. The recruitment will take at the time of surgical consent, via phone after patient is identified at the time of preoperative visit, or on the day of surgery.
- Being tested
- Heparin, Normal saline
- Keywords
- Randomized controlled trial, Heparin instillation
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Heparin is a readily available glycosaminoglycan (GAG) chemically similar to hyaluronic acid and chondroitin sulfate that is currently used to treat chronic painful bladder or interstitial cystitis. Heparin intravesical treatment is an inexpensive second-line treatment for chronic painful bladder, characterized by urinary frequency, urgency and pain. Heparin has been shown to re-establish the bladder urothelial GAG layer and as already noted was shown to reduce recurrent urinary tract infections by 50%.
Normal salineDrug
Normal saline bladder instillation
| Study group | Role | What they receive |
|---|---|---|
| Heparin Bladder Instillation | Experimental | At the completion of the scheduled benign hysterectomy, intravesicular bladder instillation containing 40,000U of heparin (40mL of 10,000U heparin/10mL) will be administered be introduced in a retrograde fashion by gravity via Foley catheter. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening. Receives: Drug: Heparin |
| Normal Saline Bladder Instillation | Placebo comparator | Patients randomized to the control group will undergo intravesical instillation with 40mL of normal saline. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower urinary tract symptoms
lower urinary tract symptoms such as urgency, frequency, dysuria, and hematuria measured by the Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA)
Measured: Postoperative day 14
Secondary outcomes (2)
Postoperative antibiotic use
Obtained via phone interview
Measured: Postoperative day 1 to 14
Postoperative patient satisfaction
Surgical Satisfaction Questionnaire (SSQ-8) assessment conducted via phone interview
Measured: Postoperative day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start20 Aug 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyde Yuen, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633994
- Sponsor's protocol ID
- TCH #18-12
- Acronym
- HILUTS
- Status last verified
- Oct 2019
- First submitted
- 13 Aug 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ablove T, Patankar M, Seo S. Prevention of recurrent urinary tract infections by intravesical administration of heparin: a pilot study. Ther Adv Urol. 2013 Dec;5(6):303-9. doi: 10.1177/1756287213504804.
PubMed 24294288Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.
PubMed 17517855Anand M, Wang C, French J, Isaacson-Schmid M, Wall LL, Mysorekar IU. Estrogen affects the glycosaminoglycan layer of the murine bladder. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):148-52. doi: 10.1097/SPV.0b013e31824b76bd.
PubMed 22543765Ciani O, Arendsen E, Romancik M, Lunik R, Costantini E, Di Biase M, Morgia G, Fragala E, Roman T, Bernat M, Guazzoni G, Tarricone R, Lazzeri M. Intravesical administration of combined hyaluronic acid (HA) and chondroitin sulfate (CS) for the treatment of female recurrent urinary tract infections: a European multicentre nested case-control study. BMJ Open. 2016 Mar 31;6(3):e009669. doi: 10.1136/bmjopen-2015-009669.
PubMed 27033958Clayson D, Wild D, Doll H, Keating K, Gondek K. Validation of a patient-administered questionnaire to measure the severity and bothersomeness of lower urinary tract symptoms in uncomplicated urinary tract infection (UTI): the UTI Symptom Assessment questionnaire. BJU Int. 2005 Aug;96(3):350-9. doi: 10.1111/j.1464-410X.2005.05630.x.
PubMed 16042729Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.
PubMed 28594764Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18.
PubMed 21272992Desai VB, Xu X. An update on inpatient hysterectomy routes in the United States. Am J Obstet Gynecol. 2015 Nov;213(5):742-3. doi: 10.1016/j.ajog.2015.07.038. Epub 2015 Jul 28. No abstract available.
PubMed 26226555Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.
PubMed 24463669Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.
PubMed 14710061Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Dis Mon. 2003 Feb;49(2):53-70. doi: 10.1067/mda.2003.7.
PubMed 12601337Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544.
PubMed 26698878Generali JA, Cada DJ. Intravesical heparin: interstitial cystitis (painful bladder syndrome). Hosp Pharm. 2013 Nov;48(10):822-4. doi: 10.1310/hpj4810-822.
PubMed 24421434Giesen LG, Cousins G, Dimitrov BD, van de Laar FA, Fahey T. Predicting acute uncomplicated urinary tract infection in women: a systematic review of the diagnostic accuracy of symptoms and signs. BMC Fam Pract. 2010 Oct 24;11:78. doi: 10.1186/1471-2296-11-78.
PubMed 20969801Givens CD, Wenzel RP. Catheter-associated urinary tract infections in surgical patients: a controlled study on the excess morbidity and costs. J Urol. 1980 Nov;124(5):646-8. doi: 10.1016/s0022-5347(17)55596-2.
PubMed 7452793
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03633994
- Acronym / sponsor ID
- HILUTS / TCH #18-12
- Keywords
- Randomized controlled trial, Heparin instillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 16 Aug 2018 (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.
This study will explore the application of placing heparin into the bladder via a catheter to decrease postoperative lower urinary tract symptoms (LUTS) and urinary tract infection (UTI) symptoms such as urinary frequency, urinary urgency, pain with urination, or difficulty voiding following hysterectomy (surgically removing the uterus). The investigators hypothesize that heparin bladder instillations will reduce LUTS, UTI symptoms, and improve patient satisfaction following hysterectomy.
Detailed description
Data Collection
Subject demographics and history information will be obtained from The Christ Hospital Medical Center's electronic medical record. In addition, preoperative diagnosis, postoperative diagnosis, procedure performed, total operative time, estimated blood loss, intraoperative complications, anterior prolapse repair, use of cystoscopy, preoperative urinalysis, postoperative complications, uterine size, and any urine cultures collected within the 2 week postoperative period will also obtained from the electronic medical record.
The post-operative lower urinary tract symptoms assessments will be collected, the paper records will be secured in a locker labeled with the study identification number, which will then be entered into EXCEL on a password secured database and the paper copy will be disposed of in the secure destruction station.
Descriptive Analysis
Simple statistics and demographics will be done across the two cohorts. Categorical variables will be analyzed using Chi-square while continuous variables (e.g. UTISA scores) will be analyzed using t-test so long as the distribution of the data are normal. Additional analyzes as appropriate will be done to identify group differences based on patient demographics (e.g. age, concomitant procedures, surgeon, estrogen use, foley catheter placement, etc).
Data Analysis and Data Monitoring
The UTISA survey and VAS pain scale both result a continuous variable that between the two cohorts will be compared using a t-Test provided the results distribution is normal. Antibiotic use or self-reported UTI rates are nominal variables that across the cohorts would be compared using a X2.
Data analysis will be performed using statistical software (JMP 13.2.0, SAS Institute Inc., Cary NC, USA). The data will be assembled into a password protected EXCEL (Microsoft, Redmond WA, USA) spreadsheet. A separate password protected spreadsheet will link the study ID and the enrolled patient's MRN. Analysis would be done only on the de-identified data.
Data Storage and Confidentiality
Study data will be managed in a password-protected EXCEL (Microsoft, Redmond WA, USA) spreadsheet on a password-protected computer. A separate password protected spreadsheet linking the study ID and MRN will be kept on a separate password-protected secure drive. This "key" file will be securely destroyed when the data has been fully analyzed. Paper records including consent will be in a locked research drawer, in the designated locked office. The investigators will dispose of any paper documents after data has been analyzed using the CINTAS Secure Destruction Station.
Sample Size
The symptom with the highest sensitivity and specificity to predict a UTI is dysuria. A study in 2013 demonstrated a 50% reduction in UTIs among heparin treated patients, the investigators estimated an effect size of 0.6, assuming mean UTISA dysuria scores of 2 and 1 among the untreated and treated cohorts assessed on post-operative day 1. Assuming an α of 0.05 and 80% power, the investigators estimate requiring 45 subjects per study arm totaling 90 patients. Assuming at least 15% attrition in each arm, the investigators estimate needing to enroll at least 52 patients per study arm to a total of 104 patients.
Plans for recruitment of subjects
No advertisement will be used. The recruitment will take at the time of surgical consent, via phone after patient is identified at the time of preoperative visit, or on the day of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin Bladder Instillation | Experimental | Drug: HeparinAt the completion of the scheduled benign hysterectomy, intravesicular bladder instillation containing 40,000U of heparin (40mL of 10,000U heparin/10mL) will be administered be introduced in a retrograde fashion by gravity via Foley catheter. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening. |
| Normal Saline Bladder Instillation | Placebo comparator | Drug: Normal salinePatients randomized to the control group will undergo intravesical instillation with 40mL of normal saline. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 85-years old
- scheduled to undergo a benign hysterectomy
Key exclusion criteria (10 listed)
- non-English speakers
- current use of anticoagulants or thrombolytic agents
- known adverse reaction or hypersensitivity to heparin
- history of or active genitourinary tract cancer (bladder, uterine, cervical, ovarian or vaginal)
- history of neurogenic bladder
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 |
|---|---|---|
| HeparinHeparin is a readily available glycosaminoglycan (GAG) chemically similar to hyaluronic acid and chondroitin sulfate that is currently used to treat chronic painful bladder or interstitial cystitis. Heparin intravesical treatment is an inexpensive second-line treatment for chronic painful bladder, characterized by urinary frequency, urgency and pain. Heparin has been shown to re-establish the bladder urothelial GAG layer and as already noted was shown to reduce recurrent urinary tract infections by 50%. | Drug | Heparin Bladder Instillation |
| Normal salineNormal saline bladder instillation | Drug | Normal Saline Bladder Instillation |
Primary outcome
Lower urinary tract symptoms
Time frame: Postoperative day 14
lower urinary tract symptoms such as urgency, frequency, dysuria, and hematuria measured by the Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA)
2 secondary outcomes
Postoperative antibiotic use
Time frame: Postoperative day 1 to 14
Postoperative patient satisfaction
Time frame: Postoperative day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Results publication: PubMed 24294288Ablove T, Patankar M, Seo S. Prevention of recurrent urinary tract infections by intravesical administration of heparin: a pilot study. Ther Adv Urol. 2013 Dec;5(6):303-9. doi: 10.1177/1756287213504804.
- Results publication: PubMed 17517855Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.
- Results publication: PubMed 22543765Anand M, Wang C, French J, Isaacson-Schmid M, Wall LL, Mysorekar IU. Estrogen affects the glycosaminoglycan layer of the murine bladder. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):148-52. doi: 10.1097/SPV.0b013e31824b76bd.
- Results publication: PubMed 27033958Ciani O, Arendsen E, Romancik M, Lunik R, Costantini E, Di Biase M, Morgia G, Fragala E, Roman T, Bernat M, Guazzoni G, Tarricone R, Lazzeri M. Intravesical administration of combined hyaluronic acid (HA) and chondroitin sulfate (CS) for the treatment of female recurrent urinary tract infections: a European multicentre nested case-control study. BMJ Open. 2016 Mar 31;6(3):e009669. doi: 10.1136/bmjopen-2015-009669.
- Results publication: PubMed 16042729Clayson D, Wild D, Doll H, Keating K, Gondek K. Validation of a patient-administered questionnaire to measure the severity and bothersomeness of lower urinary tract symptoms in uncomplicated urinary tract infection (UTI): the UTI Symptom Assessment questionnaire. BJU Int. 2005 Aug;96(3):350-9. doi: 10.1111/j.1464-410X.2005.05630.x.
- Results publication: PubMed 28594764Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.
- Results publication: PubMed 21272992Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18.
- Results publication: PubMed 26226555Desai VB, Xu X. An update on inpatient hysterectomy routes in the United States. Am J Obstet Gynecol. 2015 Nov;213(5):742-3. doi: 10.1016/j.ajog.2015.07.038. Epub 2015 Jul 28. No abstract available.
- Results publication: PubMed 24463669Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.
- Results publication: PubMed 14710061Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.
- Results publication: PubMed 12601337Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Dis Mon. 2003 Feb;49(2):53-70. doi: 10.1067/mda.2003.7.
- Results publication: PubMed 26698878Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544.
- 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.
James Whiteside, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Heparin and Normal saline in people with Lower Urinary Tract Symptoms and Postoperative Urinary Tract Infection, run by The Christ Hospital 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 10 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 10 Oct 2019. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Hoi Tik H Yuen, MD ((513) 463-2500, hoitik.yuen@thechristhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower urinary tract symptoms (time frame: Postoperative day 14). 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 NCT03633994, which also lists 29 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 10 Oct 2019.