NL-OMON56636尚未招募不适用
EPITHESIS VERSUS PROSTHESIS IN POST-PHALLOPLASTY TRANSGENDER PEOPLE - EROS
niversitair Ziekenhuis Gent0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Participant and partner age >= 18 years.
- •- Transgender or gender non-conforming individuals diagnosed according to the
- •DSM-5 diagnostic criteria for gender dysphoria.
- •- Participants have undergone phalloplasty as a form of genital gender
- •affirming surgery.
- •- >= 1 year after phalloplasty (any type of flap combination is allowed),
- •performed at the Ghent University Hospital or Amsterdam UMC.
- •- >= 3 months after coronaplasty and having reasonably pronounced coronal ridge,
- •as defined by the surgeons* expert opinion (This criterion is only obligatory
- •in the eptithesis group, not in the prosthesis group).
- •- Absence of urethral stricture or other structural problem resulting in
- •voiding dysfunction.
- •- Established (primary) sexual relationship with partner who is willing to take
- •part in the study.
- •- Participant is unable to penetrate the partner (anal or vaginal) adequately
- •sexually without the aid of supportive measures (condom, taping, penile sleeve,
- •penile epithesis or any other measure defined as supportive by the
- •investigators).
- •- Fit and eligible for erection prosthesis surgery, based on the surgeons*
- •expert opinion.
- •- No history of erection prosthesis surgery.
- •- Treatment naïve in the use of the Elatortm or Erektortm epithesis.
排除标准
- •- Participant age < 18 years. - Absence of coronaplasty or coronaplasty
- •performed < 3 months ago or coronaplasty did not leave sufficiently pronounced
- •coronal ridge as defined by the surgeons* expert opinion (This criterion is
- •only obligatory in the epithesis group, not in the prosthesis group) - Penile
- •dimensions are not anatomic (e.g. too small or too large). - Underlying LUTDs
- •requiring further investigation and/or treatment. - Participant does not have
- •sufficent sensations in the phallus - No established (sexual) partner and/or
- •partner is not willing to take part in the study. - Participant and/or partner
- •have no interest in penetrative sexual intercourse.
- •Warnings as provided by the manufacturer, adjust and summarised according to
- •the needs of the target study population:
- •1. Always apply a water or silicone based lubricant to all areas of the phallus
- •in contact with the epithesis.
- •2. To make penetration easier at the beginning of intercourse, always prepare
- •with adequate foreplay.
- •3. Should any painful or uncomfortable physical sensations arise during
- •intercourse cease the activity. Apply more lubricant or change positions if
- •needed. If this does not alleviate the discomfort then stop use of the
- •epithesis immediately to prevent injury.
- •4. Do not use the epithesis while you or your partner are under the influence
- •of alcohol or drugs that may impair judgement or alter skin sensations or
- •5. Do not fall asleep while wearing the epithesis, since prolonged inactivity
- •while wearing the epithesis may cause permanent injury to the phallus.
- •6. Use of the eptithesis does not prevent transmittion of sexually
- •transmissible diseases. Always wear a condom over the phallus and epithesis in
- •order to prevent this.
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