None listed
Conditions
Interventions
None listed
Sponsors
Myongji Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Among patients who visit our hyperbaric oxygen treatment center for hyperbaric oxygen therapy, those with erectile dysfunction and/or lower urinary tract symptoms who agree to participate in this study * Inclusion criteria ? Men with erectile dysfunction 50 years of age or older who have had sexual intercourse at least once in the past month and have a regular sexual partner (male sexual function questionnaire: IIEF-5 less than 22 points) ? Men 50 years of age or older with lower urinary tract symptoms (International Prostate Symptom Score: IPSS >8) (with or without symptoms of overactive bladder or erectile dysfunction) ? Women over 40 years of age with lower urinary tract symptoms (International Prostate Symptom Score: IPSS >8) (with or without symptoms of overactive bladder) B. Patients over 20 years of age diagnosed with interstitial cystitis and consenting to participate in this study ? Adults with age of 20 years old or above. ? Patients with symptoms of unpleasant sensation (pain, pressure, and discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 months duration, in the absence of infection or other identifiable causes. ? Patients have received cystoscopy and ruled out other bladder lesion. ? Free of active urinary tract infection (UTI). ? Free of bladder outlet obstruction on enrollment. ? Free of overt neurogenic bladder dysfunction and limitation of ambulation. ? Patient or his/her legally acceptable representative has signed the written informed consent form.
Exclusion criteria
Exclusion criteria: -Erectile dysfunction Exclusion criteria 1. a history of pelvic surgery 2. unstable medical or psychiatric disorders, neurological diseases other than diabetic neuropathy, chronic haematological diseases, or penile anatomical abnormalities and nonresponders to PDE5I 3. uncontroled DM, chr. heart, kidney, or liver dysfunction 4. Peyronie’s disease; systemic anticoagulation; uncontrolled hypertension or hypotension; severe vision loss or retinitis pigmentosa 5. trauma or surgery on the spinal cord or brain. significant cardiovascular disease within the past 3 months, hypogonadism, hyperprolactinemia, chronic prostatitis, chronic intake of central nervous system or antiandrogen drugs any fibrotic anomalies in the penis 6. untreated endocrinologic disease (including normal testosterone levels)-thyroid disease, dysfunction 7. participant’s inability to fully comply with study protocol -Lower Urinary Tract Syndrom(Male) Exclusion criteria 1. evidence of prostate cancer, previous prostatic surgery, history of AUR within 3 mo prior to study entry 2. neurogenic bladder dysfunction, urethral stricture, congenital or anatomic abnormality of the genital organ 3. malignant tumor, peptic ulcer, hemorrhagic disease, mental diseases, alcohol dependence, and drug abuse 4. bladder cancer, bladder stones, chronic bladder catheterisation, prostatitis, myasthenia gravis 5. participant’s inability to fully comply with study protocol -Lower Urinary Tract Syndrome(Female) Exclusion criteria 1. higher stage SUI, types of urinary incontinence other than SUI, Pelvic Organ Prolapse 2. neurogenic bladder dysfunction, congenital or anatomic abnormality of the genital organ 3. malignant tumor, peptic ulcer, hemorrhagic disease, mental diseases, alcohol dependence, and drug abuse 4. bladder cancer, bladder stones, chronic bladder catheterisation, myasthenia gravis 5. participant’s inability to fully comply with study protocol -Interstitial cystitis Exclusion criteria 1. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months. 2. Patients with severe cardiopulmonary diseases, such as congestive heart failure, arrhythmia, and poorly controlled hypertension, were not able to receive regular follow-up. 3. Patients with bladder outlet obstruction on enrollment. 4. Patients with uncontrolled confirmed diagnosis of acute UTI. 5. Patients have abnormal serum creatinine level greater than two times of upper limit of normal range. 6. Patients with any other serious disease considered by the investigator not in the condition to enter the trial. 7. Patient had received intravesical treatment for interstitial cystitis within recent 1 month. 8. Patients participated investigational drug trial within 1 month before entering this study. 9. participant’s inability to fully comply with study protocol *Common Exclusion criteria ? Uncontrolled high blood pressure ? claustrophobia ? Severe lung disease ? History of chemotherapy, radiation therapy, hormone therapy ? Mental disorder or continuous use of psychiatric drugs ? Taking erectile dysfunction drugs (PDE5 inhibitor, etc.) within the last 3 months ? Patients with urinary tract infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IIEF-5 (International index of erectile function) ;IPSS (International Prostate Symptom Score);OABSS (Overactive Bladder Symptom Score) ;O'Leary-Sant symptom and problem index;Visual analogue scale for pain pelvic Pain; Urgency/ Frequency (PUF) Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| endothelial function biomarkers; proinflamatory markers;perfusion MRI | — |
Countries
Korea, Republic of
Contacts
Public ContactSeo Yeon Lee
Myongji Hospital
Outcome results
None listed