Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04860492
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2021-04-13
Brief Title:
The Impact of Renalof Dietary Supplement on Upper Urinary Tract Stone Volume
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study of Agropyron Repens Mannitol and Magnesium Supplement for the Treatment of Calcium Oxalate Upper Urinary Tract Stones The AMMOS Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMMOS
Brief Summary:
Following informed consent all recruited patients will have a baseline non-contrast CT scan performed at the radiology department of G Gennimatas hospital and reported by the same dedicated uroradiologist for evaluation of stone volume location and consistency All patients will also have a free flow mid-stream urinalysis and culture before randomization
The level of pain related to stones will be evaluated in all patients with the VAS tool completed before commencement of treatment and at the end of the study
Patients with a DJ stent at study entry will also complete the mini-Ureteral Stent Symptoms Questionnaire m-USSQ and the PUF questionnaire completed one week into study before commencement of treatment and at the end of the study after taking either RENALOF or placebo Patients with a DJ stent in situ at study entry will have both ends of the DJ cut and send for culture during scheduled DJ stent change Approximately 90 days after recruitment all patients will have a follow up CT scan done at G Gennimatas hospital radiology department and evaluated by the same dedicated uroradiologist and a mid-stream urinalysis and culture Patients with a DJ in situ will have their catheters changed and cut ends from the distal and proximal stent coils of the removed DJ stents will be send for culture and sensitivity analysis All patients will complete the VAS and the cohort of patients with DJ stents will complete both the mini-USSQ and PUF questionnaires
During the study period patients will be instructed to report to the research team any cases of upper or lower urinary tract infection documented with a positive urine culture and any treatment related adverse events
The level of pain related to stones will be evaluated in all patients with the VAS tool completed before commencement of treatment and at the end of the study
Patients with a DJ stent at study entry will also complete the mini-Ureteral Stent Symptoms Questionnaire m-USSQ and the PUF questionnaire completed one week into study before commencement of treatment and at the end of the study after taking either RENALOF or placebo Patients with a DJ stent in situ at study entry will have both ends of the DJ cut and send for culture during scheduled DJ stent change Approximately 90 days after recruitment all patients will have a follow up CT scan done at G Gennimatas hospital radiology department and evaluated by the same dedicated uroradiologist and a mid-stream urinalysis and culture Patients with a DJ in situ will have their catheters changed and cut ends from the distal and proximal stent coils of the removed DJ stents will be send for culture and sensitivity analysis All patients will complete the VAS and the cohort of patients with DJ stents will complete both the mini-USSQ and PUF questionnaires
During the study period patients will be instructed to report to the research team any cases of upper or lower urinary tract infection documented with a positive urine culture and any treatment related adverse events
Detailed Description:
A total of 82 patients with renal stone or ureteral stones measured on a CT scan performed no later than 1 month prior to randomization will be recruited in the study Full medical history as well as demographic data and relevant medical treatment will be recorded in all eligible patients followed by a detailed physical examination
All eligible patients who have read and signed the study consent form will be randomized to either RENALOF or placebo
The randomization sequence will be computer-generated by the study coordinating team Randomization will be performed before enrolment of the first patient
Both the investigators and the study participants will be blinded to the treatment received RENALOF or placebo Following randomization the participants will be given prefilled non-labelled boxes containing either active drug RENALOF or placebo The pills in all boxes will be visually identical in size weight and shape Each box will have a tag with a unique code A list of all dispersed coded boxes and the type of drug each box contains RENALOF or placebo will be kept sealed by the study coordinator until the end of the study Only at the end of the study period the research team will be unblinded to the treatment each patient had received
The study will be carried out in prespecified time-points which are listed below
Point 0 P0 Screening visit and randomization
Participants will provide a written informed consent before enrolment A full medical history will be recorded including medications interventions for upper tract stones ESWL URS PCNL medical treatment for stones history of spontaneous stones passage Findings on clinical examination and patient demographic characteristics body weight height body mass index BMI will be recorded
The size number and location of stones on CT scan will be recorded along with any other relevant finding horseshoe kidney UPJ obstruction duplicate collecting system ureteric stricture etc The location size surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient All CT studies will be evaluated and stone parameters will be estimated by the same independent dedicated certified radiologist using the Invesalius computer software
All patients will have a baseline Urea and electrolytes U and E blood test free flow random sample urinalysis and culture U and E will include serum creatinine sodium potassium calcium and albumin Parathyroid hormone will also be assessed to confirm or exclude hyperparathyroidism Urinalysis includes pH specific weight sodium calcium oxalate uric acid citrate and magnesium Urine culture tests for the possibility of a urinary tract infection UTI and if necessary sensitivity will be carried out which will help treatment
Patients with indwelling DJ stents will have their stents changed under local anesthesia In order to reduce patient discomfort and stent related symptoms SRS the stent length for each patient will be estimated on the basis of individual patients height as follows height 175 cm will receive a 22F stent 175 cm 190 cm will receive a 24 F stent and patients taller than 190 cm will have a 26F stent Care will be taken that the loop of the stents in the bladder does not cross the midline The distal and proximal ends of the stent will be sent for culture Patients with DJ stents will complete a m-USSQ and a PUF questionnaire 2 weeks following stent insertion or stent change This will be done in order to avoid bias as patients will have this procedure done under local anesthesia
Patients will then be randomized and 3 unlabeled boxes containing a total of 120 pills 3-month supply of either active treatment RENALOF or placebo will be dispersed The patients will be asked to take 3 pills daily for 90 days
Point 1 P1 End of the 90-day RENALOF treatment All participants will have a follow up CT scan The location size surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient The findings will be compared to those of the baseline CT scan Estimation of all stone parameters location size surface area stone volume will be done by the same radiologist as in the screening visit in order to avoid interobserver variability Incidences of spontaneous stone passage will be recorded
All patients will have a repeat free flow urinalysis and culture and complete a VAS
Patients with DJ stents will have their stents changed and the stent ends will be sent for culture and sensitivity Patients with stents will complete a m-USSQ and PUF questionnaire Incidences of UTIs with a positive urine culture during the study period will be recorded Treatment related adverse events and drop-out rates will be recorded
Once final assessment of all recruited patients has been completed researchers will be unblinded to the type of treatment each patient has received RENALOF or placebo The patients will then form 2 groups group A n 41 those who received RENALOF and group B n 41 those who received placebo and the groups will be compared for primary and secondary study endpoints
All eligible patients who have read and signed the study consent form will be randomized to either RENALOF or placebo
The randomization sequence will be computer-generated by the study coordinating team Randomization will be performed before enrolment of the first patient
Both the investigators and the study participants will be blinded to the treatment received RENALOF or placebo Following randomization the participants will be given prefilled non-labelled boxes containing either active drug RENALOF or placebo The pills in all boxes will be visually identical in size weight and shape Each box will have a tag with a unique code A list of all dispersed coded boxes and the type of drug each box contains RENALOF or placebo will be kept sealed by the study coordinator until the end of the study Only at the end of the study period the research team will be unblinded to the treatment each patient had received
The study will be carried out in prespecified time-points which are listed below
Point 0 P0 Screening visit and randomization
Participants will provide a written informed consent before enrolment A full medical history will be recorded including medications interventions for upper tract stones ESWL URS PCNL medical treatment for stones history of spontaneous stones passage Findings on clinical examination and patient demographic characteristics body weight height body mass index BMI will be recorded
The size number and location of stones on CT scan will be recorded along with any other relevant finding horseshoe kidney UPJ obstruction duplicate collecting system ureteric stricture etc The location size surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient All CT studies will be evaluated and stone parameters will be estimated by the same independent dedicated certified radiologist using the Invesalius computer software
All patients will have a baseline Urea and electrolytes U and E blood test free flow random sample urinalysis and culture U and E will include serum creatinine sodium potassium calcium and albumin Parathyroid hormone will also be assessed to confirm or exclude hyperparathyroidism Urinalysis includes pH specific weight sodium calcium oxalate uric acid citrate and magnesium Urine culture tests for the possibility of a urinary tract infection UTI and if necessary sensitivity will be carried out which will help treatment
Patients with indwelling DJ stents will have their stents changed under local anesthesia In order to reduce patient discomfort and stent related symptoms SRS the stent length for each patient will be estimated on the basis of individual patients height as follows height 175 cm will receive a 22F stent 175 cm 190 cm will receive a 24 F stent and patients taller than 190 cm will have a 26F stent Care will be taken that the loop of the stents in the bladder does not cross the midline The distal and proximal ends of the stent will be sent for culture Patients with DJ stents will complete a m-USSQ and a PUF questionnaire 2 weeks following stent insertion or stent change This will be done in order to avoid bias as patients will have this procedure done under local anesthesia
Patients will then be randomized and 3 unlabeled boxes containing a total of 120 pills 3-month supply of either active treatment RENALOF or placebo will be dispersed The patients will be asked to take 3 pills daily for 90 days
Point 1 P1 End of the 90-day RENALOF treatment All participants will have a follow up CT scan The location size surface area and volume of each stone will be calculated and recorded as well as the total stone surface area and stone volume for each patient The findings will be compared to those of the baseline CT scan Estimation of all stone parameters location size surface area stone volume will be done by the same radiologist as in the screening visit in order to avoid interobserver variability Incidences of spontaneous stone passage will be recorded
All patients will have a repeat free flow urinalysis and culture and complete a VAS
Patients with DJ stents will have their stents changed and the stent ends will be sent for culture and sensitivity Patients with stents will complete a m-USSQ and PUF questionnaire Incidences of UTIs with a positive urine culture during the study period will be recorded Treatment related adverse events and drop-out rates will be recorded
Once final assessment of all recruited patients has been completed researchers will be unblinded to the type of treatment each patient has received RENALOF or placebo The patients will then form 2 groups group A n 41 those who received RENALOF and group B n 41 those who received placebo and the groups will be compared for primary and secondary study endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None