Research Experience:

2008-2010 Individual Research Project

Title of Project: Use of an alternative reimbursement system for bilateral scrotal orchiectomy is likely to save Medicare hundreds of millions of dollars. Goals/Contributions: Publication – in Current Urology 12/2009

2008-2015 Individual Research Project

Title of Project: Non-antibiotic treatment of urinary tract infections

Goals/Contributions: Conceptualization, device design, data analysis, successful prototype made, in processing at CSL for release to inventor

2009-10 Individual Research Project

Title of Project: Prevention of UTI’s with a top-vented catheter in a randomized, prospective, blinded study.

Goals/Contributions: Published in Current Urology with Dr. Ying Jura

2008-2013 Individual Research Project: Pilot study of a novel electrical sleep apnea/snoring device

Goals/Contributions: Perform sleep studies in external population, refine prototype electrical pads, secure venture capital funding for US studies

2012-2015 Individual Research Project: A novel office based pubovaginal sling with high safety profile

Goals/Contributions: Pilot test “dummy” prototype

2010-2012 Individual Research Project: Successful functional cystoscopy minimal-risk prototype completion

Goals/Contributions: Secure intellectual property rights through MGH/Partners, refine prototype, publish results of >20 subjects.

2012-2015 Individual Research Project: Timing of OR cases based on operative venue – How much time is gained with the proper operative theater? Goals/Contributions: Publish results at meeting, journal publication

2012-2013 Individual Research Project: Accumulation of inaccurate medications necessitates purging of old medication lists on electronic medical records. Goals/Contributions: Publish results at meeting, journal publication

2015 –2016 Botox Injection – Is Dose Escalation a more desirable method of treatment? Goals: Publish clinical data

2000 Massachusetts General Hospital Department of Urology – Develop and implement an incontinence database and questionnaires to measure quantitative improvements and losses in treatments of urinary incontinence.

1998- 2016 Massachusetts General Hospital Department of Urology – Developed a database of Radical Prostatectomy patients at MGH with detailed follow-up and pathological information. Over 2000 patients are in the database to date.

1993 Massachusetts General Hospital /Wellman Laser Laboratory – Developed and patented the Laser Illuminator. This dual-pulsed laser device improves the efficiency of prostatic resection by six fold. Conducted tests in vitro and in vivo models. Designed circuitry for CCD microsecond flash photography to coordinate laser pulses.

1988 UMDNJ-Kessler Teaching Labs – Studied the effects of demineralized bone matrix on osteogenesis in rats by subcutaneously implanting DBM in Sprague-Dawley rats.

1987 Yale University Department of Mechanical Engineering – Senior research project- Evaluated mathematically and confirmed with a machined model that viscoelastic laxity rather than ligamentous overload causes scoliosis.

1984-1985 UMDNJ- Newark Pulmonary Function Lab – Programmed IBM computer with analog to digital converters and real-time clock hardware. Gathered data on non-invasive external breathing monitors to allow timing and volume testing of individual breath trends. Statistically analyzed the data with EPISTAT software. Performed pulmonary function testing on research subjects.

1983 Stevens UPTAM Program – Programmed stepping motors for computer automation of an X-ray diffractometer using FORTRAN and MACRO assembly language subroutines. Gathered data through analog to digital converters, stored it on data files, then sent it to mainframe computer for processing and return to diffractometer site.

Clinical Innovations: 

1996 -OR Time Booking– I established time guidelines for specific procedures through the urology operations improvement committee. These guidelines allow for efficient booking of OR cases, and I established the precursor to all of the MGH OR booking software in use today.

1996 -OR Material Management-I have generated case supply materials for procedures to be picked by nursing personnel in the OR soon after the case is booked. This is the first time that this type of system was available at MGH, and is in use throughout the whole OR today.

• OR Case Booking- I have enabled the OR schedule to be more accurate by booking commonly associated multiple procedures by the most time consuming case as an index case. This system is still in use in the Urology department today.

1998    I became the first surgeon at MGH to use Interstim, which is a neuromodulation technique to treat urge urinary incontinence patients who were ineffectively treated with medications.

• I became the first surgeon at MGH to use the Monarc transobturator sling, which was an improvement in comfort for women undergoing this procedure for stress urinary incontinence

2003    I became the first surgeon at MGH to use the Perigee and Apogee systems for repair of cystocele, lateral vaginal prolapse, and rectocele via a transobturator and minimally invasive manner.

• I became the first urologist at MGH to perform laser removal of bladder tumors in the office – I established the Holmium:YAG laser safety protocols and procedures, as well as started a program that allows removal of bladder tumors in the office without anesthesia, with greater patient safety and equal efficacy.

• I started the Interstim program at MGH in 1997, which is a procedure used for refractory urge urinary incontinence. I established the outpatient safety protocols and procedures in 2005 so that these procedures could be done in the office setting with greater patient safety.

• I co-started the MGH prostate Microwave therapy for BPH with Dr. Shahin Tabatabaei. This includes establishing the safety protocols and procedures. This allowed for more effective treatment of more numbers of men with BPH who were ineligible for a TURP.

• I became the first surgeon at MGH to use office transurethral collagen injections for stress urinary incontinence – I established the safety protocols and procedures for use of collagen for treatment of stress urinary incontinence in both men and women.

2007    I became the first urologist at MGH to electronically capture and match images of the inside of the bladder for study of suction lesions from a Foley catheter. This technique can and will be also used to map and keep records of bladder tumors.

• I became the first surgeon at MGH to use transvesical Botox injections for urge urinary incontinence– I established the safety protocols and procedures for the use of Botox in the outpatient office setting.

2008     I became the first surgeon at MGH to perform, the minimally invasive “Miniarc” sling for stress urinary incontinence, and became the first surgeon to successfully perform this procedure under local anesthesia, as a prelude to establishing safety protocols to perform this procedure under local anesthesia in the office setting.

• I became the first urologist at MGH and possibly the world to perform functional cystoscopy by observing anatomically through a cystoscope and determining bladder function as well as parameters of prostatic obstruction simultaneously. This device is currently under the earliest stages of patent submission through MGH and Partners.

2015   Began tibial nerve stimulation program at MGH Danvers as minimally invasive treatment for urge urinary incontinence, with about 15-18 patients per week treated.

Legal Experience/Expert Witness Activities:

Summary: I have served as an expert witness in malpractice cases and insurance cases in a wide variety of situations, including expertise in urology, trauma, mechanical failure of operating room devices and machinery, risk treatment of medications and drugs, and occupational exposures. Although completed malpractice cases are of public record, I have not included year of testimony, court names, and names of plaintiffs or defendants in order to maximize their privacy.

Testimony in Court: 

Plaintiff Role versus MD: Half-day testimony in Superior Court on behalf of plaintiff against MD in case of rectal injury in radical prostatectomy. Result: Decision for MD after full-day deliberations.

Defense role for MD: Full-day testimony in Superior Court on behalf of physician in case of suprapubic tube injury to bowel. Pointed out that opposing attorney should not make stabbing motions when describing how a urologist performs surgery. Result: Successful expedited defense.

Defense role for MD – Full-day testimony in Superior Court on behalf of physician in case of injury to eyes alleged as a result of medical treatment. Needed to repeatedly correct opposing attorney that “narrow angle vision” and “narrow angle glaucoma” are two different entities. Testified regarding detailed drug knowledge. Result: Successful expedited defense.

Defense role for two MD’s – Full-day testimony in Superior Court on behalf of two physicians in case of death alleged as a result of failure to diagnose bladder cancer. Testified for two different defense lawyers in same case. Result: Successful expedited defense of both physicians.

Defense role for MD – Full-day testimony in Superior Court on behalf of physician in case of splenic injury in partial nephrectomy case. Testified regarding hemodilution in addition to urology surgical expertise. Result: Successful expedited defense.

Defense role for MD: Two full days of testimony in Superior Court on behalf of physician in case of neurosurgical infection after placement of sacral nerve stimulator device. Testified regarding requirements of safety studies for medical devices. Found one document in 1,700 pages of records exonerating doctor between first and second day of testimony. Result: Successful expedited defense.

Testimony at Deposition:

Defense for Insurance Company: Testified regarding mechanics of auto collision and physiology of bladder  function. Result: Successful defense without trial.

On Behalf of Plaintiff – Testified regarding missed rectal injury during radical prostatectomy. Result: Case went to trial.

Defense for Physician – Infection in nephroureterctomy with postoperative wound infection. Result: Dismissed case.

Defense for Physician – Testified regarding urinary incontinence with electrocautery treatment of BPH and resulting incontinence. Result: Settlement of case outside court.

Defense for Physician – Testified regarding urinary retention after pubovaginal sling case. Result: Settlement of case outside court.

Defense for Physician – Testified regarding missed renal cell carcinoma and death of patient. Result: Settlement of case outside court

Defense for Physician – Testified regarding urinary incontinence associated with laser prostatectomy procedure with procedure expertise, laser expertise, urodynamics expertise. 9 ¼ hours of testimony. Settlement of case outside court.

Defense for Physician – Testified regarding PSA testing and relevance of screening with prostate cancer diagnosis. Decision for physician without trial.

Defense for Physician – Testified regarding equipment failure with abdominal bowel injury with uterine perforation. Testified regarding mechanics of bowel injury as well as lack of alert of equipment notification for surgical termination of procedure. Settlement of case outside court.

Defense for Physician – Testified regarding medical treatment for prostate cancer and liver function screening with death of patient. Settlement of case outside court.

Defense for Physician – Testified regarding ureteral injury with Ligasure clamp, resulting in ureteral injury and sepsis. Settlement of case outside court.

Defense for Physician – Testified regarding missed prostate cancer and death from prostate cancer. Result: Settlement outside court.

Grocela JA, Buettner H. Implementation of a ‘Worth to Society’ reimbursement model for bilateral scrotal orchiectomy for hormonal treatment of prostate cancer is likely to save Medicare $170 million per year if surgeon’s fee is increased to $4500 US Current Urology 2009, 3, 190-3.

Grocela, JA, Kanji, A, Ternullo. JA Prediction of Medicare formulary drugs for overactive bladder. Journal of Urology 2006, 176(1), 252-5.

Grocela JA, Mauceri TA, Zietman AL. “New life after prostate brachytherapy? Considering the fertile female partner of the brachytherapy patient,” BJU International 2005.

Zietman, A, Grocela, JA, Zehr, E, Kaufman, DS, Young, RH, Althausen, AF, Heney, NM, and Shipley, WU. “Selective Bladder Conservation Using Transurethral Resection, Chemotherapy, and Radiation: Management and Consequences of Ta, T1, and Tis recurrence within the retained bladder. Urology, 58 (3), 2001.

Grocela, JA and McDougal, WS, “The Utility of Nuclear Matrix Protein (NMP22) in the detection of recurrent Bladder Cancer,” in Urologic Clinics of North America, 1999.

Grocela JA, McDougal WS, “Effects of Augmentation Cystoplasty on the Canine Ileal Brush Border” Urology, 1999.

Grocela JA, McDougal WS, “Metabolic Complications of Urinary Diversion,” in Urologic Complications, 1999.

Grocela JA and Anderson RR “Dual Pulsing of Ho:YAG Lasers to Improve Prostatic Resection” ASLMS Proceedings, 1997.

Grocela JA and Dretler SP, “History of Intracorporeal Lithotripsy” in Urologic Clinics of North America, 1996.

Grocela JA, “Effects of Sterilization Techniques on Osteogenesis in Demineralized Bone Matrix”, Waksman Student Summer Research, 1988.

Lavietes MH, Grocela JA, Maniatis T, Potulski F, “Inspiratory Muscle Strength in Asthma” Chest, May, 1988, vol. 93, no. 5, pp.1043-8.

Select Patent Filings by Inventor Joseph A. Grocela

Joseph A. Grocela has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).

Method, device and system for providing speech

Patent number: 9143106

Abstract: A device for providing speech to a user has a sound wave generator, a sound wave guide for guiding the sound wave to a user’s nasal cavity, an airflow generator for producing airflow through the sound wave guide, a pitch controller, and a volume controller. The device causes air and sound waves to pass through the user’s mouth so the user can convert the airflow and sound waves to speech. The device can have a nasal cover or nasal prongs to engage the nose. The resulting speech can be controlled to have a substantially constant volume, and can be controlled to have proper tonal inflection. The sound wave generator can provide more than one frequency at a time. The sound wave generator can be a musical instrument. The device is handheld and portable. The device can be used to train a user to control a singing voice.

Type: Grant; Filed: December 27, 2013; Date of Patent: September 22, 2015; Assignee: Grindstone Medical LLC; Inventor: Joseph A. Grocela

METHOD AND DEVICE FOR THE ELECTRICAL TREATMENT OF SLEEP APNEA AND SNORING

Publication number: 20080021506

Abstract: A device and method for the treatment of sleep apnea and/or snoring in a human patient includes at least one electrode stimulator for providing direct electrical stimulation to a throat and/or laryngeal muscles of the patient. The stimulator is constructed and arranged to be positioned at the throat and/or laryngeal muscles of the patient, either on the surface or subcutaneously. A power source provides a continuous electrical signal to the stimulator so that the throat and/or laryngeal muscles of the patient are contracted to open the airway of the patient. The power source can be a portable source remote from the electrode or a pacemaker unit also implanted in the patient.

Type: Application; Filed: May 9, 2007; Publication date: January 24, 2008; Applicant: MASSACHUSETTS GENERAL HOSPITAL; Inventor: Joseph GROCELA

Pubovaginal support for treating female urinary incontinence

Patent number: 7204801

Abstract: A device to be surgically inserted for providing bulk and stiffness supporting the urethra. A preferred embodiment is shaped like a capital letter “T.” The extensions of the T are wide compared to the patient’s anterior vagina and urethra. The pubovaginal support is positioned or implanted under the urethra in the area from mid-urethra to the bladder neck. The body is folded, rolled, or otherwise arranged to provide bulk under the urethra. The pubovaginal support is constructed to be relatively stiff in the area directly supporting the urethra. The extensions retain the device in its position in the vagina without the need for abdominal or pubic bone anchors. The device additionally has some flexibility for easier insertion and comfort while retained in the body. A method of treating incontinence includes inserting the device into pockets dissected in the peri-urethral tissue between the vagina and urethra.

Type: Grant; Filed: January 17, 2003; Date of Patent: April 17, 2007; Assignee: Massachusetts General Hospital; Inventor: Joseph A. Grocela

Post-radical prostatectomy continence implant

Publication number: 20040143343

Abstract: A spacer useful for relieving excess pressure exerted on a sphincter muscle by an anatomical structure. A preferred embodiment relates to a urethral spacer. The urethral spacer is a disk-like element formed of an absorbable, biodegradable material, and includes a slot through a portion of the device which permits the disk to be opened up and positioned around the urethra. The urethral spacer is sutured in place around the urethra adjacent to or around the urinary sphincter, preferably after a radical prostatectomy.

Type: Application; Filed: January 17, 2003; Publication date: July 22, 2004; Inventor: Joseph A. Grocela

Pubovaginal sling for treating female urinary incontinence

Publication number: 20040143152

Abstract: A device to be surgically inserted for providing bulk and stiffness supporting the urethra. A preferred embodiment is shaped like a capital letter “T.” The T extensions of the T are wide compared to the patient’s anterior vagina and urethra. The pubovaginal sling is positioned or implanted under the urethra in the area from mid-urethra to the bladder neck. The body is folded, rolled, or otherwise arranged to provide bulk under the urethra. The pubovaginal sling is constructed to be relatively stiff in the area directly supporting the urethra. The extensions retain the device in its position in the vagina without the need for abdominal or pubic bone anchors. The device additionally has some flexibility for easier insertion and comfort while retained in the body. Alternative embodiments include material with increased bulk and stiffness in the body area adjacent to the urethra, and do not include a folded or rolled portion of the body.

Type: Application; Filed: January 17, 2003; Publication date: July 22, 2004; Inventor: Joseph A. Grocela

Two-pulse, lateral tissue illuminator

Patent number: 5776127

Abstract: A two-pulse, lateral tissue illuminator in which a first pulse delivered by a first optical waveguide is used to irradiate a liquid-containing region to form a vapor bubble; a second pulse, delivered by a second optical waveguide, is then passed through the vapor bubble and used to incise a tissue of a patient. The illuminating device can be used to effectively deliver radiation to tissue positioned laterally relative to the axis of the delivery fibers, and allows a reduction in the attenuation of the radiation by the surrounding liquid.

Type: Grant; Filed: October 29, 1996; Date of Patent: July 7, 1998; Assignee: The General Hospital Corporation; Inventors: Richard Rox Anderson, Joseph A. Grocela

Two-pulse, lateral tissue illuminator

Patent number: 5632739

Abstract: A two-pulse, lateral tissue illuminator in which a first pulse delivered by a first optical waveguide is used to irradiate a liquid-containing region to form a vapor bubble; a second pulse, delivered by a second optical waveguide, is then passed through the vapor bubble and used to incise a tissue of a patient. The illuminating device can be used to effectively deliver radiation to tissue positioned laterally relative to the axis of the delivery fibers, and allows a reduction in the attenuation of the radiation by the surrounding liquid.

Type: Grant; Filed: October 13, 1994; Date of Patent: May 27, 1997; Assignee: The General Hospital Corporation; Inventors: Richard R. Anderson, Joseph A. Grocela 

Grocela, JA, Kanji, A, Ternullo. JA Prediction of Medicare formulary drugs for overactive bladder. Journal of Urology 2006, 176(1), 252-5.

Grocela JA, Mauceri TA, Zietman AL. “New life after prostate brachytherapy? Considering the fertile female partner of the brachytherapy patient,” BJU International 2005.

Zietman, A, Grocela, JA, Zehr, E, Kaufman, DS, Young, RH, Althausen, AF, Heney, NM, and Shipley, WU. “Selective Bladder Conservation Using Transurethral Resection, Chemotherapy, and Radiation: Management and Consequences of Ta, T1, and Tis recurrence within the retained bladder. Urology, 58 (3), 2001.

Grocela, JA and McDougal, WS, “The Utility of Nuclear Matrix Protein (NMP22) in the detection of recurrent Bladder Cancer,” in Urologic Clinics of North America, 1999.

Grocela JA, McDougal WS, “Effects of Augmentation Cystoplasty on the Canine Ileal Brush Border” Urology, 1999.

Grocela JA, McDougal WS, “Metabolic Complications of Urinary Diversion,” in Urologic Complications, 1999.

Grocela JA and Anderson RR “Dual Pulsing of Ho:YAG Lasers to Improve Prostatic Resection” ASLMS Proceedings, 1997.

Grocela JA and Dretler SP, “History of Intracorporeal Lithotripsy” in Urologic Clinics of North America, 1996.

Grocela JA, “Effects of Sterilization Techniques on Osteogenesis in Demineralized Bone Matrix”, Waksman Student Summer Research, 1988.