Evaluation of Penile Prosthesis Pump Manipulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength
研究概览
简要总结
Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with penetration.
Unfortunately, current prostheses are difficult (or even impossible) to manipulate for some patients. Many patients underutilize their device due to difficulties in using the pump related to mechanical issues (difficult grip, lack of strength, etc.) or sensory issues (altered proprioception, etc.), resulting in an inability to achieve rigidity that allows optimal satisfaction for the patient and/or partners.
These difficulties correspond to a significant portion of dissatisfaction among patients with penile prostheses.
Actually, no study has evaluated patients' ability to manipulate the pump of their penile prosthesis, as well as the association between these manipulation abilities, the rigidity of erections with a penile prosthesis, and patient and partner sexual satisfaction.
In this descriptive study, the primary outcome is to describe the manipulation abilities of patients with penile prostheses during follow-up consultations after prosthesis implantation.
The secondary outcomes are to estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with
- Rigidity of erections with penile prosthesis
- Patient's sexual satisfaction
- Partner's sexual satisfaction
- Satisfaction related to pump manipulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patients will be included based on the following criteria:
- •Erectile Dysfunction, and had undergone penile prosthesis implantation for more than 3 months
- •Able to comprehend the nature and purpose of the research
- •Having provided informed consent
- •The partner will be included based on the following criteria :
- •Having a partner who meets the inclusion criteria
- •Able to comprehend the nature and purpose of the research
- •Having provided informed consent
排除标准
- •Patients with a dysfunctional penile prosthesis (reservoir, pump, or cylinders anomaly)
- •Adults subject to legal protective measures.
- •Individuals not affiliated with a social security scheme or beneficiaries of a similar scheme.
研究组 & 干预措施
Patients who have undergone penile prosthesis implantation > 3 months ago and their partner
Evaluation of the manipulation abilities of patients with penile prostheses Evaluation of the rigidity of erections with penile prosthesis, the patient and partner's sexual satisfaction, the satisfaction related to pump manipulation
干预措施: Evaluation (Other)
结局指标
主要结局
Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength
时间窗: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Measurement of overall hand grip strength using the JAMAR dynamometer. The force is expressed in kg.
Describing the manipulation abilities of patients with penile prosthesis : proprioception
时间窗: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Measurement of proprioception with a object recognition test : the "Moberg pick-up test". The patient must recognize (with eyes closed) objects that he has previously seen and held in his hand. A score ranging from 0 to 12 will thus be obtained.
Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength
时间窗: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Measurement of pinch grip strength using the "pinch test".The force is expressed in kg.
Describing the manipulation abilities of patients with penile prosthesis :discrimination
时间窗: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Measurement of discrimination with a two points touch test. Evaluation of the smallest perceived distance between two points, expressed in mm.
Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living
时间窗: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Evaluation of upper limb function for activities of daily living: the Quick DASH (Disabilities of the Arm, Shoulder and Hand). A score ranging from 11 to 55 will thus be obtained.
次要结局
- Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire)(At inclusion (during a standard of care follow-up consultation from 3 months post-surgery))
- Correlation of manipulation parameters (main outcome) with rigidity of erections(At inclusion (during a standard of care follow-up consultation from 3 months post-surgery))
- Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS(At inclusion (during a standard of care follow-up consultation from 3 months post-surgery))
- Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP(At inclusion (during a standard of care follow-up consultation from 3 months post-surgery))
- Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction(At inclusion (during a standard of care follow-up consultation from 3 months post-surgery))