Monday, September 14, 2015

Blue Light Cystoscopy for Bladder Cancer

Bladder cancer is the fourth leading cause of cancer death in males and the most common site of cancer in the urinary system. An estimated 74,000 new cases of bladder cancer are expected to be diagnosed in the USA in 2015 and 16,000 deaths are estimated[1]. Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence and also a risk of progression that requires patients to undergo regular monitoring with cystoscopy after transurethral resection of the bladder tumor (TURBT). Current standard of care uses white-light cystoscopy (WLC) to map and resect all visible tumors. This blog will give an overview of the use of fluorescent cystoscopy in the management of NMIBC and review the evidence for its use.

Product Overview

Blue-light cystoscopy (BLC), also referred to as fluorescent cystoscopy or photodynamic diagnosis (PDD), is a procedure in which a photosensitizer medication is instilled in the bladder prior to cystoscopy. This photosensitizer is part of the heme biosynthesis pathway (that makes red blood cells) and causes an accumulation of photoactive porphyrins in neoplastic cells. These porphyrins preferentially accumulate in neoplastic cells due to the increased metabolic activity in these cells. When excited with blue-light in the 360-450 nm wavelength, the porphyrins emit a red light that can easily be seen during cystoscopy (Figure 1). There are two main photosensitizers that have been used in studies looking at fluorescent cystoscopy: 5-aminolevulinic acid (5-ALA) and hexaminolevulinate (HAL). HAL is the only photosensitizer that has been approved for use in the USA and Europe. In the USA it is marketed under the brand name Cysview, and in Europe under the brand name Hexvix.
Figure 1. 63 year old female with prior TURBT+BCG now with recurrence. (a) WLC of a prior resection site near a ureteral orifice. (b) Same site using BLC. Tumor was found to be high grade T1. (c) WLC showing an area of CIS that was missed upon repeat resection. (d) Same site using BLC.
From: Daneshmand, et al.[2]

Increased Tumor Detection

Most studies are in agreement that more tumors are found when using BLC compared to WLC alone. Perhaps the best evidence for this is a meta-analysis published in 2013 which looked at the raw data from 6 prospective studies including a total of over 800 patients[3]. This meta-analysis found that a significant proportion of tumors were missed by WLC alone. In fact, an additional 14.7% of Ta tumors were detected with BLC, 10.8% of T1 tumors, and 40.8% of CIS (carcinoma in situ or flat tumors) (Figure 2). Another meta-analysis by Shen et al4. failed to show a statistically significant difference in tumor detection rates between BLC and WLC, however this study was limited by the inclusion of a large number of studies which used the photosensitizer 5-ALA, which is not FDA approved and has been shown to have less fluorescent properties than HAL.

Figure 2. Increased detection of tumors using BLC alone when compared to WLC alone.
From: Burger, et al.[3]

Recurrence Free Survival

While the data on increased detection are consistent, data on recurrence-free survival (RFS) are less clear-cut. Cysview gained FDA approval following a study by Stenzl et al5. published in 2010. This study was a prospective, randomized, multi-center study that looked at 551 patients with suspected Ta or T1 disease and were randomized to either WLC or WLC+BLC. During the 9-month surveillance period, 47% of patients in the BLC group and 56% of patients in the WLC group had tumor recurrences for a relative reduction of 16%. Interestingly, the following year Stenzl published another paper which randomized patients to either 5-ALA or placebo which failed to show a difference in recurrence-free survival 12 months after tumor resection6. However, as previously mentioned, this study used 5-ALA which is not the FDA approved photosensitizer.

The study with the longest follow-up data is actually an extension to the original Stenzl study used for FDA approval. This study was published in 2012 by Grossman et al7. and showed that with a median follow-up for 53.0 months (WLC group) and 55.1 months (BLC group), 38% of the patients in the BLC group remained tumor free vs. 31.8% in the WLC group. The median time to recurrence was 16.4 months in the BLC group and 9.4 months in the WLC group. This study also looked at progression-free survival and cystectomy rates but was unable to show a statistical difference between the two groups, possibly due to the original study not being powered to look at differences in these outcomes.

Figure 3 summarizes additional studies that have looked at recurrence-free survival for BLC vs. WLC.

Figure 3. Summary of studies that have looked at recurrence-free survival for BLC vs. WLC.


Cost

Bladder cancer is one of the mostly costly cancers to treat on a per capita basis. Lifetime per capita costs have been estimated between $96,000 and $187,000 (2001 US dollars)8. Multiple analyses have looked at whether using BLC could reduce cost for bladder cancer treatments using the assumption that if a patient has a longer recurrence-free survival, they may require fewer or perhaps less frequent TURBTs. Garfield et al9. used a probabilistic decision-tree model and estimated that over 5 years, approximately $4,600 could be saved per patient by using BLC during diagnostic cystoscopy (excluding the cost of the equipment).

Indications

The current AUA guidelines for bladder cancer were written in 2007, 3 years before Cysview was approved for use in the USA and therefore do not have an official recommendation for the use of fluorescent cystoscopy in the management of NMIBC. The NCCN guidelines acknowledge that BLC has been shown to decrease recurrence in NMIBC but has not been shown to reduce progression. They suggest that “BLC may have the greatest advantage in detecting difficult-to-visualize tumors (eg, CIS tumors)” and “the limitations of BLC require judicious application of this additional diagnostic tool”10.

In 2013, an expert focus group convened in San Diego to create a consensus statement for appropriate use of BLC in the USA2. Based on the evidence reviewed, they recommend that BLC should be considered:
- At initial TURBT on suspicion of NMIBC
- In patients with positive urine cytology but negative WLC findings
- In patients with intermediate-risk NMIBC
- For assessment of disease recurrence

These recommendations are similar to consensus statements and guidelines from Europe.

Summary

Blue-light cystoscopy has been shown to increase detection of NMIBC during TURBT. Whether this increased detection leads to a difference in recurrence or progression is less clear. Most studies to date, especially those with longer follow-up times, have shown a decrease in recurrence in patients who undergo TURBT with BLC. No study to date has shown a difference in progression. It is likely that to show a statistically significant difference in progression, larger studies with longer follow-up will need to be conducted.

This blog was written by Kevin Curtiss, a medical student at Johns Hopkins School of Medicine. Kevin recently finished a four-week sub-internship at the Brady Urological Institute and gave a presentation to the department on "Blue Light Cystoscopy" from which this blog is inspired. Kevin is looking forward to a career in urology.





REFERENCES
1. Cancer of the Urinary Bladder - SEER Stat Fact Sheets. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed September 2, 2015.
2. Daneshmand S, Schuckman AK, Bochner BH, et al. Hexaminolevulinate blue-light cystoscopy in non-muscle-invasive bladder cancer: review of the clinical evidence and consensus statement on appropriate use in the USA. Nat Rev Urol. 2014;11(10):589-596. doi:10.1038/nrurol.2014.245.
3. Burger M, Grossman HB, Droller M, et al. Photodynamic diagnosis of non-muscle-invasive bladder cancer with hexaminolevulinate cystoscopy: a meta-analysis of detection and recurrence based on raw data. Eur Urol. 2013;64(5):846-854. doi:10.1016/j.eururo.2013.03.059.
4. Shen P, Yang J, Wei W, et al. Effects of fluorescent light-guided transurethral resection on non-muscle-invasive bladder cancer: a systematic review and meta-analysis. BJU Int. 2012;110(6 Pt B):E209-E215. doi:10.1111/j.1464-410X.2011.10892.x.
5. Stenzl A, Burger M, Fradet Y, et al. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol. 2010;184(5):1907-1913. doi:10.1016/j.juro.2010.06.148.

6. Stenzl A, Penkoff H, Dajc-Sommerer E, et al. Detection and clinical outcome of urinary bladder cancer with 5-aminolevulinic acid-induced fluorescence cystoscopy : A multicenter randomized, double-blind, placebo-controlled trial. Cancer. 2011;117(5):938-947. doi:10.1002/cncr.25523.
7. Grossman HB, Stenzl A, Fradet Y, et al. Long-term decrease in bladder cancer recurrence with hexaminolevulinate enabled fluorescence cystoscopy. J Urol. 2012;188(1):58-62. doi:10.1016/j.juro.2012.03.007.
8. Botteman MF, Pashos CL, Redaelli A, Laskin B, Hauser R. The health economics of bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003;21(18):1315-1330. http://www.ncbi.nlm.nih.gov/pubmed/14750899. Accessed September 2, 2015.
9. Garfield SS, Gavaghan MB, Armstrong SO, Jones JS. The cost-effectiveness of blue light cystoscopy in bladder cancer detection: United States projections based on clinical data showing 4.5 years of follow up after a single hexaminolevulinate hydrochloride instillation. Can J Urol. 2013;20(2):6682-6689. http://www.ncbi.nlm.nih.gov/pubmed/23587507. Accessed September 2, 2015.

10. NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. 2015;http://www. http://www.nccn.org/professionals/physician_gls/PDF/bladder.pdf. Accessed September 2, 2015.

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  37. Very nice blog. Thank you so much for sharing with us. Kindly suggest me the best urology & andrology hospitals in India. Thanks again.

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  38. This is the most wonderful thing i have ever experienced. I visited here online on the 17 june and i saw a marvelous testimony of Tracie Aldana from United States on the forum about the good works DR.tunde I never believed it, because have never heard anything about such miracle before. No body would have been able to convince me about it not until DR.tunde did a marvelous work for me that restored my mairage of 4 years by getting back my husband back i just as i read on the internet. I'm carolina peter I was truly shocked when my husband knelt down pleading for forgiveness to accept him back. I am really short of words to use to show my appreciation to DR.tunde For his a God sent to me and my entire family for divine restoration of my mariage. Contact him now for any kind of help via Email:babatundesolutioncentre1@gmail.com or you can contact his whatsapp mobile line +2348143581382 Also specialise in treating all kinds of illness, HERPES VIRUS, HIV AIDS, HEPATITIS B, CANCER, BRAIN DISEASE, PREGNANCY AND MORE.

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  39. If you have Herpes in your whole body such as fever blisters, hsv, or roofing shingles you know what it is like to stay with the pain and discomfort that herpes delivers. I don't need to tell you how awesome it would be to find something that works so well that you no longer need to fear about stress or outbreak,Dr Itua herbal medicine cure my herpes in two weeks of taking it.is genuine and natural herbal medicine it has no side effect, The reason I'm writing this is that I promised Dr Itua I will share his herbal work to the world to see Herpes is no more a big deal.also Dr Itua can as well cure the following diseases...HIV,Hsv 1/2,Hepatitis B,Cancer, Diabetes, Men/Woman Infertility, Scoliosis,Fibromyalgia,Fluoroquinolone Toxicity
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  40. Irrespective of receiving daily oral or future injectable depot therapies, these require health care visits for medication and monitoring of safety and response. If patients are treated early enough, before a lot of immune system damage has occurred, life expectancy is close to normal, as long as they remain on successful treatment. However, when patients stop therapy, virus rebounds to high levels in most patients, sometimes associated with severe illness because i have gone through this and even an increased risk of death. The aim of “cure”is ongoing but i still do believe my government made millions of ARV drugs instead of finding a cure. for ongoing therapy and monitoring. ARV alone cannot cure HIV as among the cells that are infected are very long-living CD4 memory cells and possibly other cells that act as long-term reservoirs. HIV can hide in these cells without being detected by the body’s immune system. Therefore even when ART completely blocks subsequent rounds of infection of cells, reservoirs that have been infected before therapy initiation persist and from these reservoirs HIV rebounds if therapy is stopped. “Cure” could either mean an eradication cure, which means to completely rid the body of reservoir virus or a functional HIV cure, where HIV may remain in reservoir cells but rebound to high levels is prevented after therapy interruption.Dr Itua Herbal Medicine makes me believes there is a hope for people suffering from,Parkinson's disease,Schizophrenia,Cancer,Scoliosis,Fibromyalgia,Fluoroquinolone Toxicity
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    ReplyDelete
  41. I am 29 years old and I was diagnosis of Breast cancer, easy well and have a similar story except my first acceptance as a Herbal medicine denials. I wasn’t into the movement Perseid and didn’t establish connections with any of them really, just had faith in believing how they work. I say this because it was during using Dr Itua herbal medicine i now then testify herbal medicine is real, Dr Itua herbal medicine cure my breast cancer I was suffering from for 2 years. Dr Itua herbal medicine is made of natural herbs which has no side effect and is easy to drink as well. Contact Dr Itua herbal Center if you are suffering from the same Breast Cancer or any kind of human Diseases including....HIV/AIDS, HERPES COLORECTAL CANCER, BLADDER CANCER, PROSTATE CANCER, KIDNEY CANCER, LUNG CANCER, SKIN CANCER, UTERINE CANCER, LEUKEMIA, VIRUS, HEPATITIS, WOMEN/MEN INFERTILITY, LOVE SPELL,LOTTERY SPELL. HIS CONTACT EMAIL/WHATSAPP: drituaherbalcenter@gmail.com/+2348149277967

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  42. M R Hospitals, the leading Urology Hospital in Chennai give the service of consulting with the best urology doctor in Chennai. For more details call us : 044 2363 3313.

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  43. The information you share is very helpful. Thank you.
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  44. This is the most wonderful thing i have ever experienced. I visited here online on the 17 June and i saw a marvelous testimony of Tracie Adana from United States on the forum about the good works DR.tunde I never believed it, because have never heard anything about such miracle before. No body would have been able to convince me about it not until DR.tunde did a marvelous work for me that restored my marriage of 4 years by getting back my husband back i just as i read on the internet. I'm Carolina peter I was truly shocked when my husband knelt down pleading for forgiveness to accept him back. I am really short of words to use to show my appreciation to DR.tunde For his a God sent to me and my entire family for divine restoration of my marriage. Contact him now for any kind of help via Email:babatundesolutioncentre1@gmail.com or you can contact his whats-app mobile line +2348143581382 Also specialize in treating all kinds of illness, HERPES VIRUS, HEPATITIS B, CANCER, BRAIN DISEASE, PREGNANCY, DIABETES AND MORE

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  45. The information you share is very helpful, Thank you. Dr Ashish Kumar Saini is a best urology doctor in Delhi. Dr. Saini has got a rich experience of 14 years in his field as he has done more than 5800 urology surgeries when practicing in AIIMS for 4 years.

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  46. I am very much delighted. To everyone reading this,i want to inform the public on how i got cured from stage 2 ovarian cancer by Dr Itua Herbal Medicines. i have been suffering from ovarian cancer, and i have also taken treatment from my doctor but no way out,few weeks back i came on the internet to see if i will be able to get any information as to curing Cancers, on my search i saw various testimony of people who was healed from Uterine Cancers and Brain Tumors by the good doctor, called Dr Itua. without any hesitation, i contacted his email: drituaherbalcenter@gmail.com and i wrote him and and he guided me,i asked him for solutions and he started the remedies for me so i started using the medicine, after the period of three weeks given to me by Dr Itua i was completely cured nomore tumors on my body was found anymore. So dear viewer why living your life in therapist or chemo?contact him now on WhatsApp +2348149277967 he is able to cure the listed diseases:Arthritis,Amyotrophic Lateral Scoliosis,Brain Tumor,Fibromyalgia,Pancreative Cancer,Fluoroquinolone ToxicityBladder cancer,Brain cancer,Hiv,Herpes,Esophageal cancer,Kidney cancer,Gallbladder cancer,Gestational trophoblastic disease,Head and neck cancer,Hodgkin lymphoma,Thyroid Cancer,Uterine cancer,Fibroid,Angiopathy, Ataxia,
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    ReplyDelete
  47. I am very surprise for the miraculous experience and wonders of Dr Ilekhojie that have been spread on the internet and worldwide, How he marvelously helped people all over world to restored back their lost lovers I contacted him after going through so many testimonies from different people how he help to bring back ex lover back, i told him about my husband that abandoned me about 8 months ago, and left home with all i had, i was baffled when he only told me to smile and have a rest of mind assuring me that he will handle all in just 48 hours, After the second day my husband called me, i was just so shocked, i pick the call and couldn't believe my ears, he was really begging me to forgive him and making promises on phone,He come back home and also got me a very nice gifts just for him to proof his love for me, i was so happy that i had to call Dr Ilekhojie and thanked him, he only told me to share the good news all over the world,Well if your need an effective and real spell caster for any problem in your life you can contact Dr Ilekhojie on his email: gethelp05@gmail.com or his WhatsApp/Viber him on: +2348147400259

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  48. Very impressive article! The blog is highly informative and has answered all my questions.
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  49. Get rid of Cold Sores, unexpected Outbreak and Herpes Virus? then you don't have to keep waiting for treatment when the is a herbal medicine that cure this virus. I was searching online for Herbal Cure for Herpes Virus when I saw a testimony online about Dr. Akintunde and how he cured a lady of HSV1 with his.
    natural herbal medicine and tested Negative and in less than a month she was cured of this virus. So it took me time to believe that this was true, because my family Doctor tried all his best to get rid of this virus in my body system but yet no cure and I suffered from outbreak and Cold Sores always. I had to contact Dr. Akintunde after I have access his website and i had faith in God that I was going to be fine and free of this virus one day. Finally I contacted Dr. Akintunde on his WhatsApp number that I saw on the testimony post online, and after our conversation the Doctor only promise me that I was going to be cured and free of this virus after taking his natural herbal medicine because I was tired of my situation with this virus it was so distracting to my life and whole family. Later Dr. Akintunde send some Herbal medicine to me through UPS courier service, with instructions on how to used this medicine, to my biggest surprise first week of taking my herbal medication I saw great improvement and I still think that it's a dream but this is real, I now test Negative of this virus today and my blood pressure well regulated now, my family doctor after my test was extremely surprise to see my test result change to HSV1 Negative and no more symptoms, cold sores, sores throat and outbreak again. I wish to tell everyone about this, mostly if you have this virus then do yourself good to contact Dr. Akintunde and see what the Lord can do through this Herbal Doctor's medicine in less than a month. 100% free from herpes Virus. I and my family say "thank you" Sir, for helping my life. You are a blessing to this generation and God will reward you richly

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    ReplyDelete

  50. Greetings to you all, i am here today for my family life testimony on how I was cured from HPV while this may sound discouraging and people may not believe that HPV &HIV CURE has be found, while i was once an HIV i live with this disease for more than a year now, i have been to so many places for help including hospitals wasted money and times hoping that i was going to get cure but non was able, until God use someone to cure me from this disease HPV true the help of a man called Dr EBHOTA with his herbal root herbs medicine. while i don’t have much to say but to give thanks and praise to God almighty who use Dr Ebhota to extend my life for what you have done for me DR, i will not stop thanking you because you put a smile on my face again. thanks once again if you are into similar problem or with any kind of diseases you can contact Sir Dr EBHOTA call him on +2348089535482 or WhatsApp and i will not stop thanking you Dr EBHOTA . for what you have done for me in my life, i will keep posting to the world for them to know that you are in existence, thanks for your audience and i hope you find help like i did for what he has done for me, if you are into similar problem like...
    1. BREAST CANCER
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    :: whatsapp him on this +2348089535482 or inbox him on drebhotasolutoin@gmail.com God will bless you Sir for the work of my family.,,,,,,,,,,,,,,,,,, 

    ReplyDelete
  51. I want to quickly tell the world that there is a real and effective online spell caster that is powerful and genuine, His name is Dr Ilekhojie , he helped me recently to reunite my relationship with my husband who left me, When i contacted Dr Ilekhojie, he cast a love spell for me, and my husband who said he doesn't have anything to do with me again, called me and started begging me to come back. he is back now with so much love and care. Today i am glad to let you all know that this spell caster have the powers to restore broken relationship and bring them back. because i am now very happy with my husband. To everyone who is reading this article and needs his help, Dr Ilekhojie can also offer any type of help like, resolving Divorce Cases, Court Cases, Death Spell, Spiritual protection. Thank you! Ilekhojies contact gethelp05@gmail.com or call +2348147400259

    ReplyDelete
  52. Get Your Wife Back, Perfect Urgent Love Spell. Am Karen Renee from FL Usa All Thanks To Dr Osasu Who Brought Back The Love Of My Life. my girlfriend cheated on me and asked for a breakup. I don't believe at first i try to get back with her but all she told me was she’s with someone else. that she is no longer interested in marrying me at that point i was heart broken because i love my girlfriend so much that i could not let go off her all of a sudden she left me, i really love her and never can imagine my life without her. not until i came across a powerful real spell caster Dr Osasu who promise me 24hours urgent love spell to get back with my girlfriend, good twenty-four {24} hours. hmm-mm, it was a good night time at 11:pm within the days that Dr Osasu told me that my girlfriend will be back, at first i heard the bell rings getting close to my door i heard someone saying honey!!!, it sound familiar i opened the door and i saw my girlfriend standing and weeping in front of me. i was not surprised because its all i have been praying for her to come back home. Guess what 2 weeks after she noticed her system and her body temperature was changed and i took her to clinic for check up and the doctor told me that there is life in her which means she was pregnant i really wants to use this opportunity to thanks Dr Osasu so much and the love page that directed me to Dr Osasu if you have any problem getting your ex back, or predicament that is worse or exactly like this you have been into, contact Dr Osasu on drosasu25@gmail.com You can add him up on Whats-app/ Or call +2347064365391

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  53. HOW DR. UNEME brought back my ex lover unemespellben@gmail.com
    Am DONNA, am from UK. After been in a relationship with my Boyfriend for 1 year now and we were planning to get married soon and all of a sudden he left me for another girl. of a truth, I really love this guy and never can I imagine life without him. I further tried all my best to get him back but all my effort to get him back in my life did not work out. It was on this faithful day, I came across some Testimonies on a website about this great spell caster called (Dr. UNEME) any persons claimed that he help them to renew their relationship and bring their ex lover back, I had to contact him because he was my last hope. I contacted him through his email and he assured me that in three days time my boyfriend is going to leave the other girl and come back to me and it was a very great surprise to see my boyfriend coming back to me after three days the spell was done. I am so very happy today that he came back to me and i achieved this with the help of Dr UNEME I equally want to use this opportunity to Tell/Advice to as many who need their ex back, if you need his help you can Contact him through
    EMAIL: unemespellben@gmail.com WHATSAPP HIM @ +2348143813120


    Thank You Once Again Dr.UNEME

    ReplyDelete
  54. HOW DR. UNEME brought back my ex lover unemespellben@gmail.com
    Am DONNA, am from UK. After been in a relationship with my Boyfriend for 1 year now and we were planning to get married soon and all of a sudden he left me for another girl. of a truth, I really love this guy and never can I imagine life without him. I further tried all my best to get him back but all my effort to get him back in my life did not work out. It was on this faithful day, I came across some Testimonies on a website about this great spell caster called (Dr. UNEME) any persons claimed that he help them to renew their relationship and bring their ex lover back, I had to contact him because he was my last hope. I contacted him through his email and he assured me that in three days time my boyfriend is going to leave the other girl and come back to me and it was a very great surprise to see my boyfriend coming back to me after three days the spell was done. I am so very happy today that he came back to me and i achieved this with the help of Dr UNEME I equally want to use this opportunity to Tell/Advice to as many who need their ex back, if you need his help you can Contact him through
    EMAIL: unemespellben@gmail.com WHATSAPP HIM @ +2348143813120


    Thank You Once Again Dr.UNEME

    ReplyDelete
  55. HI!!!
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  56. Thanks for this effort you have put in this knowledgeable blog. find best urologist in Bangalore in the world of urology

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  57. I am Sophie from Canada, I once suffered from a terrible and Chronic fibromhyalgia,since i was bone , the doctor told me there was no permanent cure i was given medications to slow down its progress, i constantly felt my health was deteriorating as i constantly had Pain all over my body,this ailment was really terrible especially when am going out with my friends, i have this constant disorder for about 31 years, this was really a terrible ailment ,on thin one day that i was going through the internet,and i came across a post of Mrs jessica on how her daughter was been cured from  fibromhyalgia through the help of Dr Williams herbal product, I contacted this herbal doctor via his email and explain everything to him and make purchase of his product,few days later he sent me the herbal medicine through courier service, when i received the herbal medicine, i used it for 1 months and two weeks as prescribed by dr williams and i was totally cured within those week of usage,on thin now i have not experience any sign or characteristics again . for more information you can email him on drwilliams098675@gmail.com for help

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