Evaluation the Efficacy and Safety of Hyperbaric Oxygen Therapy in Sildenafil Non Responder Erectile Dysfunction Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in sexual health inventory for men (SHIM)
研究概览
简要总结
Erectile dysfunction patients who are non responder to sildenafil will be treated with hyperbaric oxygen therapy with 100% concentration and at 2 ATM for 30 consecutive sessions each one 90 minutes and then will be reassessed.
详细描述
This study is double blinded randomized controlled clinical trial that includes organic ED patients who attend to the Andrology out patient clinics, Department of Dermatology, Venerology and Andrology, Sohag University hospital, Sohag, Egypt. Informed consent was obtained from all patients. The study was submitted for approval by Ethical and Research committees at Sohag Faculty of Medicine, Sohag University, Sohag, Egypt.
Study design:
Patients were divided into two groups (randomly assigned and comparably cross matched for age). Both patients and the investigators were blinded as regard the treatment until the end of the study.
Group 1: Patients assigned to the HBOT group were treated with (30) sessions in consecutive days (90 minutes of 100% oxygen at 2.2 ATM).
Group 1: Patients assigned to control group were exposed to (30) sessions of air oxygen tension at 2.2 ATM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blinded randomized controlled trial
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with regular sexual relationship in the last 6 months
- •having organic ED and
- •non responder to Sildenafil were included in our study.
排除标准
- •Hypogonadism,
- •History of Pelvic trauma, surgery or disease,
- •Receiving treatment in the last 3 months,
- •History of premature ejaculation,
- •History of spinal cord or brain disease,
- •History of drug abuse,
- •Patients without a regular sexual partner,
- •Patients with advanced kidney disease (creatinine>1.3 mg\dl) or liver disease,
- •History of psychiatric diseases,
- •HBOT exclusion as open pneumo-thorax, chest disease, sezure and congestive heart failure.
研究组 & 干预措施
100% oxygen
ED patients in this group exposed to hyperbaric oxygen 100 % concentration at 2.2 ATM for 90 minutes for 30 consecutive sessions.
干预措施: hyperbaric oxygen therapy within hyperbaric oxygen therapy chamber. (Device)
ordinary room oxygen
ED patients in this group exposed to normal air oxygen concentration at 2.2 ATM for 90 minutes for 30 consecutive sessions.
干预措施: hyperbaric oxygen therapy within hyperbaric oxygen therapy chamber. (Device)
结局指标
主要结局
Change in sexual health inventory for men (SHIM)
时间窗: Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.
The SHIM is a five-item scale in which each item is scored from 0 to 5 on four items and 1 to 5 on one item. It includes four of the six items from the original erectile function domain of the IIEF and includes items in maintenance ability, erection confidence, maintenance frequency and erection firmness in addition to a single item on intercourse satisfaction. Among men in a relationship with a partner, including those men who have opportunity but no desire to attempt sexual activity or intercourse. Disease grades of ED on SHIM scores were categorized as follows: severe ED (SHIM score:1-7), moderate ED (8-11), mild-to-moderate ED(12-16), mild (17-21), and no ED (22-25). A cut off value of 21 was chosen, so that patients with scores of 21 or less were classified as having had ED while patients with scores above 21were classified as having no ED (Shamloul et al., 2004).
Change in Erection Hardness Score (EHS)
时间窗: Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.
The EHS is a single-item instrument that asks men to rate erection hardness on a scale that ranges from 0 (penis does not enlarge) to 4 (penis is completely hard and fully rigid) (Arafa and Shamloul, 2009).
Change in the Sexual health encounter profile (SEP- Questions 2 and 3):
时间窗: Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.
The treatment efficacy evaluated through asking the patients to answer the SEP-Q2 and SEP-Q3 with yes or no (Tsetsvadz A. et al., 2009). SEP-Q2: Were you able to insert your penis into your partner's vagina? SEP-Q3: Did your erection last long enough for you to have successful intercourse?
次要结局
- Change in Penile color Doppler:(Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.)
研究者
Haisam Abdelrhman Ahmed Mohamed
Assistant lecturer
Sohag University