Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment

NCT01955408 | Completed

• 1 other identifier: SYNERGO-OAB
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder carcinoma is the most common malignancy of the urinary tract. Approximately 75-85% of patients with bladder cancer present with a disease that is confined to the mucosa or submucosa. These categories are grouped as non-muscle-invasive bladder tumors(i.e. superficial tumors). Bladder cancer is the fifth most common cancer in the United States, with an estimated 67,160 newly diagnosed cases and 13,750 deaths in the United States in 2007. The 5-year survival rate is 82% for all stages combined. The standard of treatment for patients with superficial bladder cancer is surgical transurethal resection (TUR) of tumors, with an 80% early success rate. However, nearly 70% of these patients will develop tumor recurrence, with 25% showing progression to muscle-invading disease, within 5 years with TUR. It is therefore necessary to consider adjuvant therapy in all patients. The absolute risks of recurrence and progression do not always indicate the risk at which a certain therapy is optimal. The choice of therapy may be considered differently according to what risk is acceptable for the individual patient and the urologist. Intravesical chemotherapy and immunotherapy are widely used as adjuvant therapies after TUR, to prevent recurrence and progression of superficial disease. Systemic therapy is typically reserved for higher stage, muscle-invading, or metastatic diseases. The urinary bladder is an ideal organ for regional therapy. The urethra provides easy access of therapeutic agents to the urinary bladder. The presence of the specialized asymmetric unit membrane on the urothelium serves as a barrier and limits the absorption of molecules or particulates into the systemic circulation. The rationale for intravesical therapy is to maximize the exposure of tumors located in the bladder cavity to therapeutics agents while limiting the systemic exposure and thereby limiting the host toxicities; the primary goal is to eradicate existing or residual tumors through direct cytoablation or immunostimulation. The unique properties of the urinary bladder render it a fertile ground for evaluating novel approaches to regional therapy, including local hyperthermia, co-administration of permeation enhancers, bioadhesive carriers, and gene therapy. One of the developing treatments for high-risk superficial bladder cancers is the combination of intravesical chemotherapy and hyperthermia (HT), called chemohyperthermia (C-HT). The most common form of C-HT uses the Synergo HT system, in which local HT is administered via direct microwave irradiation of the urothelium by means of a 915-MHz intravesical microwave applicator. The target intravesical temperature is set between 41.8C and 44.8C and is measured by five thermocouples integrated in a 20-F treatment catheter. To avoid injury, the urethra is continuously cooled. Due to extensive global experience with its use and a significant amount of preclinical data demonstrating improved antineoplastic efficacy when heated, mitomycin C (MMC) is the most common intravesical chemotherapy agent used in conjunction with HT. The most common adverse events during treatment were bladder spasms and bladder pain. Literature reports bladder spasms in 21.6% of patients, and bladder pain in 17.5%. Bladder spasms tended to occur more frequently with the prophylactic schedule, whereas pain was present equally in the prophylactic and ablative schedules but more commonly after the ablative schedule. In the first days following C-HT, storage LUTS (frequency, dysuria, urgency, nocturia) (25.6%) and hematuria (6.0%) are the most common adverse events. Most studies mention that these symptoms were mild and transient, resolving spontaneously within a few days of treatment. One study described severe cystitis complaints in three patients (16%), but other studies have not confirmed these adverse events. Two studies report the development of a contracted bladder and severe urinary incontinence after ablative C-HT. However, the possibility cannot be excluded that previous transurethral resection and intravesical chemotherapy might have contributed to this event. Following the appearance of bothersome storage LUTS, patient should be managed by existing guidelines. Based on AUA/SUFU Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults Guidelines published in 2012 patients should be diagnosed, followed and treated according to the suggested algorithm. In our study, we would like to assess the severity of OAB symptoms and their response to a standard OAB treatment according to AUA Guidelines for Non-neurogenic OAB as well as to assess urodynamic study variables in those who didn't respond to a standard medical treatment and bothered by their OAB symptoms.

Conditions

Overactive Bladder; Bladder Cancer; Synergo

Keywords

overactive bladder; bladder cancer; Synergo; urodynamic study

Outcome Measures

Primary Outcomes (2)

• OAB symptoms severity and urodynamic variables in failed medical treatment patients

  OAB-SS, OAB-Q, OAB-SQ - questionnaires Urodynamic study results in patients who will undergo the test

  at recruitment and after treatment

• Synergo treatment variables and OAB severity

  relationship between the answers in OAB-SS, OAB-Q, OAB-SQ - questionnaires, Urodynamic study results in patients who will undergo the test and type of Synergo protocol, number of treatments received, time of hyperthermia per treatment, bladder cancer stage at the beginning of Synergo treatment.

  at recruitment and after treatment

Secondary Outcomes (2)

• OAB severity of symptoms and urodynamic variables in failed medical treatment patients

  after the treatment

• OAB treatment satisfaction and urodynamic variables in failed medical treatment patients

  after the treatment

Study Arms (1)

Overactive bladder after Synergo

Other: Questionnaires, anticholinergic treatment, urodynamic study

Interventions

Questionnaires, anticholinergic treatment, urodynamic study OTHER

Overactive bladder after Synergo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bladder cancer patients after Synergo treatment completion and no evidence of disease at cystoscopic evaluation

You may qualify if:

• both genders
• age above 18
• bladder cancer patients after completion of Synergo treatment
• no evidence of disease at cystoscopic evaluation after completion of Synergo treatment

You may not qualify if:

• children
• pregnant women
• failure to complete Synergo treatment
• evidence of bladder cancer at cystoscopic evaluation after Synergo treatment

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Hasharon, 44410, Israel

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Bladder Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael Vainrib, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 7, 2013
• Study Start: September 30, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

IL (1)