Status:
COMPLETED
Study of the Effect of Testosterone Treatment on Metabolic Parameters and Urinary Symptoms in Bariatric Patients
Lead Sponsor:
University of Florence
Conditions:
Obesity
Hypogonadism
Eligibility:
MALE
25-65 years
Brief Summary
The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible for bariatric surgery, the effect of testosterone replacement therapy in improving lower urinary tract sympt...
Detailed Description
Primary objective: \- Evaluation in obese and hypogonadal patients candidates for bariatric surgery of the effect of testosterone replacement therapy in improving the symptoms of LUTS (assessed using...
Eligibility Criteria
Inclusion
- Male subjects
- Age between 25 and 65 years
- Obese men, candidate to a bariatric surgery (body mass index (BMI) is ≥40 kg/m2, or if their BMI is \>35 kg/m2 and they suffer from other life-threatening co-morbidities such as Type 2 Diabetes Mellitus, hypertension and cardiovascular disease)
- Men with LUTS defined by: IPSS ≥ 8.
- Evidence of a personally signed and dated informed consent
Exclusion
- Bladder failure or Neurogenic bladder
- LUT disease (Urethral stenosis, diverticula)
- LUT surgery (Prostatectomy, bladder neck surgery, TURP)
- Severe systemic disease
- Previous or concomitant neoplasm
- Unable to consistently and accurately complete the protocol
- Abuse alcohol or drugs
- Psychiatric disease
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02248467
Start Date
May 1 2013
End Date
June 1 2018
Last Update
October 12 2018
Active Locations (1)
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1
Ambulatori Medicina della Sessualità e Andrologia
Florence, Italy