Postoperative Urinary RetentionPURNCT05969145
The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention
A study testing application of thermophor in people with Postoperative Urinary Retention, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The development of postoperative urinary retention (PUR) is a significant complication in patients undergoing treatment due to orthopedic surgery. In particular, it is reported that the incidence rate of PUR after spinal anesthesia is in the range of 6-60%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Urinary Retention
- What is being tested?
- application of thermophor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age,
- no urinary catheter inserted during the perioperative process, conscious and orientated,
- no renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
- voluntary acceptance to participate in the study.
Who cannot join
- <18 years of age,
- intellectual disability or perception problem,
- communication disability,
- renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
Trial locations and contacts
1 site in 1 country.
About this study
The development of postoperative urinary retention (PUR) is a significant complication in patients undergoing treatment due to orthopedic surgery. In particular, it is reported that the incidence rate of PUR after spinal anesthesia is in the range of 6-60%. It is stated in the literature that PUR can be prevented by reviewing factors such as bladder physical examination, fluid intake status, anesthesia type, bladder discharge time/condition of patients undergoing orthopedic surgery. For this purpose, our study showed that these patients had globular physical examination screening and postoperative 2-6. it aims to prevent postoperative urinary retention by applying hot and cold Decontamination to the bladders of patients who cannot urinate spontaneously between hours.
Read the detailed description
Orthopedic surgery is a surgical treatment method based on the correction of the functions of bones, November muscles, tendons, and ligaments in the body. Arthroplasty (hip, knee, shoulder), arthroscopy (meniscopathy, rotator cuff rupture), limb fractures, structural (hallux vagus, hallux rigidities, carpal tunnel syndrome, trigger finger), and developmental (hip dysplasia) dysfunctions are the interventions in which the orthopedic surgical procedure is performed. In orthopedic surgeries, the need for surgical treatment increases every day as a result of degeneration in the musculoskeletal system with a decrease in mobilization due to advancing age, November illness, trauma, or technological developments. In the United States, 30% of major surgical interventions involve orthopedic surgeries performed on elderly individuals); in Turkey, it is reported that 33.5% of orthopedic surgeries are performed due to trauma, and about 48% are performed on the lower extremities. Orthopedic surgeries are practices that risk serious complications, as with any treatment option. Complications such as nausea, vomiting, headache, hypotension, and postoperative urinary retention (PUR), especially due to spinal anesthesia, may be observed in patients receiving treatment due to orthopedic surgery. While the prevalence of PUR in orthopedic surgeries is 6-40% in the literature, it is stated that this rate is higher (6-60%) after spinal anesthesia. Due to PUR after orthopedic surgery, there is an increase in hospital stay times, susceptibility to infection, deterioration in the quality of life, and associated cost increases.
Postoperative urinary retention is a complication that manifests symptoms with problems such as suprapubic pain, bladder spasm, and/or inability to urinate after surgical treatment. The etiology of PUR includes factors caused by the patient (advanced age, male gender, anatomical problems, comorbidity, neural transmission disorders), due to the surgical process (failure to empty the bladder during the preoperative period, surgery lasts longer than 2 hours, emergency surgery, opioid-NSAID-atropine use, amount of fluid taken) and due to anesthesia (epidural/spinal anesthesia). 2-6 of the postoperative period. it gives symptoms as a result of the absence of the first urine decrement between hours. As a result, serious problems such as increased urinary pressure and acute kidney injury and/or dysfunction due to bladder distension occur in patients. Management of PUR can be achieved by using physical examination (globe monitoring), bladder catheterization, and ultrasonographic (USG) methods to diagnose these problems at an early stage.
Field health professionals, who have an important place in the conduct of health services, offer the greatest contribution to the surgical treatment process with their understanding of quality health care. In particular, nurses who are actively involved in the perioperative process are the professional staff with the greatest responsibility for positively managing health care. Nurses help to ensure the patient's comfort as soon as possible by providing multidisciplinary cooperation in the management of complications that develop during this process. For this purpose, nurses need to carry out the necessary practices and precautions against the risk of developing PUR, which is one of the postoperative complications. In the recently published Nursing Regulation, the nurses' authority to manage PUR is clearly stated as "interventions to be implemented by a nursing decision" as "A nurse can decide independently or jointly with a physician to insert and remove a urinary catheter if she cannot eliminate urinary retention with the interventions she can apply", "Hot-cold application" intervention definition is clearly stated. Therefore, nurses evaluate the patient by reviewing the existing risk factors of the patient and surgical process during the perioperative period, providing emotional support for surgical stress, questioning perioperative fluid intake, informing the patient about the consumption of caffeine-containing drinks and plenty of water, monitor urine postoperatively, prefer non-invasive methods (listening to water sound, relaxation, bladder massage, mobilization, hot-cold application, ko mot/duck/sliders) primarily in case of PURE development, and invasive methods as a last resort (urinary catheterization, ensuring the necessary cooperation with the physician for interventional applications is one of the important responsibilities in process management. In the literature, it is stated that hot-cold application with bladder catheterization, one of the invasive methods, and hot-water insertion of the hand, massage, mobilization, promotion of liquid and coffee consumption, pelvic muscle exercise, and acupuncture are used in the management of PUR. In the studies conducted, the first postoperative urine output time was reduced by sacral massage in the management of PUR nurses; there was a rapid and permanent decrease in the development of PUR accompanied by the urination algorithm from 21% to 3% observed. However, 59.5% of patients with a hot compress applied to the bladder and 71.4% with cold application had urinary retention regressed; a significant difference in the severity of urinary retention was revealed by hot application; it is reported that urinary catheterization after the hot application is applied to only 3.9% of the patients. Based on these results, it is seen that the practices used by nurses to prevent and manage PUR have resulted in positive outcomes; the hot and cold practice has also made significant contributions to PUR management. For this purpose, it is envisaged that our study will contribute to the effective management of hot-cold application of PUR to the bladder in orthopedic surgery patients, to the minimum preference of invasive applications, to increasing the awareness of nurses about PUR management, and to the literature.
- Conditions
- Postoperative Urinary Retention
- Being tested
- application of thermophor
- Keywords
- orthopedic surgery, hot-cold application, postoperative urinary retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of thermophorProcedure or surgery
The experimental group will be given hot and cold application to the bladder
| Study group | Role | What they receive |
|---|---|---|
| hot-cold application | Experimental | This group will be given a hot cold application to the bladder Receives: Procedure: application of thermophor |
| control group | No intervention | Routine clinical functioning will be applied to this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter, questionnaire
prevention of postoperative urinary retention by applying hot and cold to the bladder
Measured: the first 6 hours of the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Nov 2023
- Primary completion10 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Postoperative Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single-blind randomized controlled trial to determine the effect of hot-cold application to the bladder on postoperative urinary retention in orthopedic surgery patients.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Demirden Erişti, Ankara Yildirim Beyazıt University
- Investigators
- Gulay Yazici, Study director, Assoc. Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969145
- Sponsor's protocol ID
- Ankara Bilkent Sehir Hastanesi
- Acronym
- PUR
- Status last verified
- Jan 2024
- First submitted
- 10 May 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asahara H, Inui M, Lotz MK. Tendons and Ligaments: Connecting Developmental Biology to Musculoskeletal Disease Pathogenesis. J Bone Miner Res. 2017 Sep;32(9):1773-1782. doi: 10.1002/jbmr.3199. Epub 2017 Jul 13.
PubMed 28621492Lum ZC, Pereira GC, Giordani M, Meehan JP. Top 100 most cited articles in orthopaedic surgery: An update. J Orthop. 2019 Dec 2;19:132-137. doi: 10.1016/j.jor.2019.11.039. eCollection 2020 May-Jun.
PubMed 32025120Casari FA, Navab N, Hruby LA, Kriechling P, Nakamura R, Tori R, de Lourdes Dos Santos Nunes F, Queiroz MC, Furnstahl P, Farshad M. Augmented Reality in Orthopedic Surgery Is Emerging from Proof of Concept Towards Clinical Studies: a Literature Review Explaining the Technology and Current State of the Art. Curr Rev Musculoskelet Med. 2021 Apr;14(2):192-203. doi: 10.1007/s12178-021-09699-3. Epub 2021 Feb 5.
PubMed 33544367Parry SM, Puthucheary ZA. The impact of extended bed rest on the musculoskeletal system in the critical care environment. Extrem Physiol Med. 2015 Oct 9;4:16. doi: 10.1186/s13728-015-0036-7. eCollection 2015.
PubMed 26457181LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, Siris ES. The clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022 Oct;33(10):2049-2102. doi: 10.1007/s00198-021-05900-y. Epub 2022 Apr 28.
PubMed 35478046Waljee J, Zhong L, Baser O, Yuce H, Fox DA, Chung KC. The incidence of upper and lower extremity surgery for rheumatoid arthritis among Medicare beneficiaries. J Bone Joint Surg Am. 2015 Mar 4;97(5):403-10. doi: 10.2106/JBJS.N.00802.
PubMed 25740031Franke A, Bieler D, Wilms A, Hentsch S, Johann M, Kollig E. [Treatment of gunshot fractures of the lower extremity: Part 2: Procedures for secondary reconstruction and treatment results]. Unfallchirurg. 2014 Nov;117(11):985-94. doi: 10.1007/s00113-014-2636-x. German.
PubMed 25398508Moosavi Tekye SM, Alipour M. Comparison of the effects and complications of unilateral spinal anesthesia versus standard spinal anesthesia in lower-limb orthopedic surgery. Braz J Anesthesiol. 2014 May-Jun;64(3):173-6. doi: 10.1016/j.bjane.2013.06.014. Epub 2013 Oct 25.
PubMed 24907876Fernandez MA, Karthikeyan S, Wyse M, Foguet P. The incidence of postoperative urinary retention in patients undergoing elective hip and knee arthroplasty. Ann R Coll Surg Engl. 2014 Sep;96(6):462-5. doi: 10.1308/003588414X13946184902523.
PubMed 25198980David M, Arthur E, Dhuck R, Hemmings E, Dunlop D. High rates of postoperative urinary retention following primary total hip replacement performed under combined general and spinal anaesthesia with intrathecal opiate. J Orthop. 2015 Nov 18;12(Suppl 2):S157-60. doi: 10.1016/j.jor.2015.10.020. eCollection 2015 Dec.
PubMed 27047216Scholten R, Kremers K, van de Groes SAW, Somford DM, Koeter S. Incidence and Risk Factors of Postoperative Urinary Retention and Bladder Catheterization in Patients Undergoing Fast-Track Total Joint Arthroplasty: A Prospective Observational Study on 371 Patients. J Arthroplasty. 2018 May;33(5):1546-1551. doi: 10.1016/j.arth.2017.12.001. Epub 2017 Dec 13.
PubMed 29306574Kort NP, Bemelmans Y, Vos R, Schotanus MGM. Low incidence of postoperative urinary retention with the use of a nurse-led bladder scan protocol after hip and knee arthroplasty: a retrospective cohort study. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):283-289. doi: 10.1007/s00590-017-2042-5. Epub 2017 Sep 12.
PubMed 28900757Abdul-Muhsin HM, Jakob N, Cha S, Zhang N, Schwartz A, Navaratnam A, Khan A, Humphreys M. Incidence, Outcomes, and Prediction of Postoperative Urinary Retention After a Nonurologic Procedure. J Am Acad Orthop Surg Glob Res Rev. 2020 May;4(5):e1900149. doi: 10.5435/JAAOSGlobal-D-19-00149.
PubMed 33970584Balderi T, Mistraletti G, D'Angelo E, Carli F. Incidence of postoperative urinary retention (POUR) after joint arthroplasty and management using ultrasound-guided bladder catheterization. Minerva Anestesiol. 2011 Nov;77(11):1050-7. Epub 2011 May 11.
PubMed 21597444Bjerregaard LS, Bogo S, Raaschou S, Troldborg C, Hornum U, Poulsen AM, Bagi P, Kehlet H. Incidence of and risk factors for postoperative urinary retention in fast-track hip and knee arthroplasty. Acta Orthop. 2015 Apr;86(2):183-8. doi: 10.3109/17453674.2014.972262. Epub 2014 Oct 10.
PubMed 25301436
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention
- ClinicalTrials.gov ID
- NCT05969145
- Acronym / sponsor ID
- PUR / Ankara Bilkent Sehir Hastanesi
- Conditions
- Postoperative Urinary Retention
- Keywords
- orthopedic surgery, hot-cold application, postoperative urinary retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 1 Aug 2023 (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.
The development of postoperative urinary retention (PUR) is a significant complication in patients undergoing treatment due to orthopedic surgery. In particular, it is reported that the incidence rate of PUR after spinal anesthesia is in the range of 6-60%. It is stated in the literature that PUR can be prevented by reviewing factors such as bladder physical examination, fluid intake status, anesthesia type, bladder discharge time/condition of patients undergoing orthopedic surgery. For this purpose, our study showed that these patients had globular physical examination screening and postoperative 2-6. it aims to prevent postoperative urinary retention by applying hot and cold Decontamination to the bladders of patients who cannot urinate spontaneously between hours.
Detailed description
Orthopedic surgery is a surgical treatment method based on the correction of the functions of bones, November muscles, tendons, and ligaments in the body. Arthroplasty (hip, knee, shoulder), arthroscopy (meniscopathy, rotator cuff rupture), limb fractures, structural (hallux vagus, hallux rigidities, carpal tunnel syndrome, trigger finger), and developmental (hip dysplasia) dysfunctions are the interventions in which the orthopedic surgical procedure is performed. In orthopedic surgeries, the need for surgical treatment increases every day as a result of degeneration in the musculoskeletal system with a decrease in mobilization due to advancing age, November illness, trauma, or technological developments. In the United States, 30% of major surgical interventions involve orthopedic surgeries performed on elderly individuals); in Turkey, it is reported that 33.5% of orthopedic surgeries are performed due to trauma, and about 48% are performed on the lower extremities. Orthopedic surgeries are practices that risk serious complications, as with any treatment option. Complications such as nausea, vomiting, headache, hypotension, and postoperative urinary retention (PUR), especially due to spinal anesthesia, may be observed in patients receiving treatment due to orthopedic surgery. While the prevalence of PUR in orthopedic surgeries is 6-40% in the literature, it is stated that this rate is higher (6-60%) after spinal anesthesia. Due to PUR after orthopedic surgery, there is an increase in hospital stay times, susceptibility to infection, deterioration in the quality of life, and associated cost increases.
Postoperative urinary retention is a complication that manifests symptoms with problems such as suprapubic pain, bladder spasm, and/or inability to urinate after surgical treatment. The etiology of PUR includes factors caused by the patient (advanced age, male gender, anatomical problems, comorbidity, neural transmission disorders), due to the surgical process (failure to empty the bladder during the preoperative period, surgery lasts longer than 2 hours, emergency surgery, opioid-NSAID-atropine use, amount of fluid taken) and due to anesthesia (epidural/spinal anesthesia). 2-6 of the postoperative period. it gives symptoms as a result of the absence of the first urine decrement between hours. As a result, serious problems such as increased urinary pressure and acute kidney injury and/or dysfunction due to bladder distension occur in patients. Management of PUR can be achieved by using physical examination (globe monitoring), bladder catheterization, and ultrasonographic (USG) methods to diagnose these problems at an early stage.
Field health professionals, who have an important place in the conduct of health services, offer the greatest contribution to the surgical treatment process with their understanding of quality health care. In particular, nurses who are actively involved in the perioperative process are the professional staff with the greatest responsibility for positively managing health care. Nurses help to ensure the patient's comfort as soon as possible by providing multidisciplinary cooperation in the management of complications that develop during this process. For this purpose, nurses need to carry out the necessary practices and precautions against the risk of developing PUR, which is one of the postoperative complications. In the recently published Nursing Regulation, the nurses' authority to manage PUR is clearly stated as "interventions to be implemented by a nursing decision" as "A nurse can decide independently or jointly with a physician to insert and remove a urinary catheter if she cannot eliminate urinary retention with the interventions she can apply", "Hot-cold application" intervention definition is clearly stated. Therefore, nurses evaluate the patient by reviewing the existing risk factors of the patient and surgical process during the perioperative period, providing emotional support for surgical stress, questioning perioperative fluid intake, informing the patient about the consumption of caffeine-containing drinks and plenty of water, monitor urine postoperatively, prefer non-invasive methods (listening to water sound, relaxation, bladder massage, mobilization, hot-cold application, ko mot/duck/sliders) primarily in case of PURE development, and invasive methods as a last resort (urinary catheterization, ensuring the necessary cooperation with the physician for interventional applications is one of the important responsibilities in process management. In the literature, it is stated that hot-cold application with bladder catheterization, one of the invasive methods, and hot-water insertion of the hand, massage, mobilization, promotion of liquid and coffee consumption, pelvic muscle exercise, and acupuncture are used in the management of PUR. In the studies conducted, the first postoperative urine output time was reduced by sacral massage in the management of PUR nurses; there was a rapid and permanent decrease in the development of PUR accompanied by the urination algorithm from 21% to 3% observed. However, 59.5% of patients with a hot compress applied to the bladder and 71.4% with cold application had urinary retention regressed; a significant difference in the severity of urinary retention was revealed by hot application; it is reported that urinary catheterization after the hot application is applied to only 3.9% of the patients. Based on these results, it is seen that the practices used by nurses to prevent and manage PUR have resulted in positive outcomes; the hot and cold practice has also made significant contributions to PUR management. For this purpose, it is envisaged that our study will contribute to the effective management of hot-cold application of PUR to the bladder in orthopedic surgery patients, to the minimum preference of invasive applications, to increasing the awareness of nurses about PUR management, and to the literature.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a single-blind randomized controlled trial to determine the effect of hot-cold application to the bladder on postoperative urinary retention in orthopedic surgery patients.
| Arm | Type | Receives |
|---|---|---|
| hot-cold application | Experimental | Procedure: application of thermophorThis group will be given a hot cold application to the bladder |
| control group | No intervention | –Routine clinical functioning will be applied to this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age,
- no urinary catheter inserted during the perioperative process, conscious and orientated,
- no renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
- voluntary acceptance to participate in the study.
Key exclusion criteria (4 listed)
- <18 years of age,
- intellectual disability or perception problem,
- communication disability,
- renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
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 |
|---|---|---|
| application of thermophorThe experimental group will be given hot and cold application to the bladder | Procedure or surgery | hot-cold application |
Primary outcome
physiological parameter, questionnaire
Time frame: the first 6 hours of the postoperative period
prevention of postoperative urinary retention by applying hot and cold to the bladder
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 28621492Asahara H, Inui M, Lotz MK. Tendons and Ligaments: Connecting Developmental Biology to Musculoskeletal Disease Pathogenesis. J Bone Miner Res. 2017 Sep;32(9):1773-1782. doi: 10.1002/jbmr.3199. Epub 2017 Jul 13.
- Background: PubMed 32025120Lum ZC, Pereira GC, Giordani M, Meehan JP. Top 100 most cited articles in orthopaedic surgery: An update. J Orthop. 2019 Dec 2;19:132-137. doi: 10.1016/j.jor.2019.11.039. eCollection 2020 May-Jun.
- Background: PubMed 33544367Casari FA, Navab N, Hruby LA, Kriechling P, Nakamura R, Tori R, de Lourdes Dos Santos Nunes F, Queiroz MC, Furnstahl P, Farshad M. Augmented Reality in Orthopedic Surgery Is Emerging from Proof of Concept Towards Clinical Studies: a Literature Review Explaining the Technology and Current State of the Art. Curr Rev Musculoskelet Med. 2021 Apr;14(2):192-203. doi: 10.1007/s12178-021-09699-3. Epub 2021 Feb 5.
- Background: PubMed 26457181Parry SM, Puthucheary ZA. The impact of extended bed rest on the musculoskeletal system in the critical care environment. Extrem Physiol Med. 2015 Oct 9;4:16. doi: 10.1186/s13728-015-0036-7. eCollection 2015.
- Background: PubMed 35478046LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, Siris ES. The clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022 Oct;33(10):2049-2102. doi: 10.1007/s00198-021-05900-y. Epub 2022 Apr 28.
- Background: PubMed 25740031Waljee J, Zhong L, Baser O, Yuce H, Fox DA, Chung KC. The incidence of upper and lower extremity surgery for rheumatoid arthritis among Medicare beneficiaries. J Bone Joint Surg Am. 2015 Mar 4;97(5):403-10. doi: 10.2106/JBJS.N.00802.
- Background: PubMed 25398508Franke A, Bieler D, Wilms A, Hentsch S, Johann M, Kollig E. [Treatment of gunshot fractures of the lower extremity: Part 2: Procedures for secondary reconstruction and treatment results]. Unfallchirurg. 2014 Nov;117(11):985-94. doi: 10.1007/s00113-014-2636-x. German.
- Background: PubMed 24907876Moosavi Tekye SM, Alipour M. Comparison of the effects and complications of unilateral spinal anesthesia versus standard spinal anesthesia in lower-limb orthopedic surgery. Braz J Anesthesiol. 2014 May-Jun;64(3):173-6. doi: 10.1016/j.bjane.2013.06.014. Epub 2013 Oct 25.
- Background: PubMed 25198980Fernandez MA, Karthikeyan S, Wyse M, Foguet P. The incidence of postoperative urinary retention in patients undergoing elective hip and knee arthroplasty. Ann R Coll Surg Engl. 2014 Sep;96(6):462-5. doi: 10.1308/003588414X13946184902523.
- Background: PubMed 27047216David M, Arthur E, Dhuck R, Hemmings E, Dunlop D. High rates of postoperative urinary retention following primary total hip replacement performed under combined general and spinal anaesthesia with intrathecal opiate. J Orthop. 2015 Nov 18;12(Suppl 2):S157-60. doi: 10.1016/j.jor.2015.10.020. eCollection 2015 Dec.
- Background: PubMed 29306574Scholten R, Kremers K, van de Groes SAW, Somford DM, Koeter S. Incidence and Risk Factors of Postoperative Urinary Retention and Bladder Catheterization in Patients Undergoing Fast-Track Total Joint Arthroplasty: A Prospective Observational Study on 371 Patients. J Arthroplasty. 2018 May;33(5):1546-1551. doi: 10.1016/j.arth.2017.12.001. Epub 2017 Dec 13.
- Background: PubMed 28900757Kort NP, Bemelmans Y, Vos R, Schotanus MGM. Low incidence of postoperative urinary retention with the use of a nurse-led bladder scan protocol after hip and knee arthroplasty: a retrospective cohort study. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):283-289. doi: 10.1007/s00590-017-2042-5. Epub 2017 Sep 12.
- 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.
Gulay Yazici study director
Assoc. Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of thermophor in people with Postoperative Urinary Retention, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
physiological parameter, questionnaire (time frame: the first 6 hours of the postoperative period). 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 NCT05969145, which also lists 48 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 31 Jan 2024.