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临床试验/NCT04052217
NCT04052217已完成不适用

Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse

King's College London2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Overall Sexual Pleasure on a Visual Analogue Scale

研究概览

简要总结

Our hypothesis is that reducing the length of the penis does not lead to loss of sexual satisfaction or emotional closeness in the female partner. This will be investigated by a single case experimental design in 12 couples.

详细描述

The investigators will conduct a single case experimental design (SCED), in which a woman acts as her own control with a reversal design between randomly allocated phases. These include a control phase (A) and phases with various sizes of penile rings (B, C, and D).

The male participant will be asked to measure the length and girth of their erect penis using standardized instructions and flexible tape measure before the start of the experiment. This will partly determine the inner circumference of the ring provided. The male participant will be given instructions on how to use the penile rings and ensure that the female participant is blind to the size of the ring used.

There will be randomization (a) to the phase (the size of ring) and (b) the number of times of intercourse within a phase. The male partner will be blind to ratings made by the female partner. There is no carry over effect from one phase to another. The randomization of the phase means less guessing of the size of the ring, and less interaction with moderators (e.g. menstrual cycle, alcohol, holiday or life events randomly spread across phases). In a SCED, one then replicates in Case 2, Case 3 etc and a meta-analysis is conducted of all the single cases.

Randomisation will occur to either

  1. Phase A "Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse)
  2. Phase B - 1" ring randomised to either 3, 4, or 5 episodes of intercourse)
  3. Phase C - 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse)
  4. Phase D - 2" ring randomised to either 3, 4, or 5 episodes of intercourse) The male partner will be kept informed by text or email or phone (whichever is convenient) of when to change the size of ring and the number of times it should be used. The female partner will be asked to be blind to the size of ring used after each episode of intercourse. Blindness will be tested by asking if the female partner "saw" the size of the ring or whether she was able to guess when a change in the size of the ring occurred.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Masking of female participant

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
接受健康志愿者

入选标准

  • Heterosexual couples in a stable relationship (defined as 6 months or more)
  • Having regular intercourse (defined as on average twice a week).

排除标准

  • Any current sexual dysfunction in either partner
  • Any current emotional disorder in either partner
  • Men with a micro-penis

研究组 & 干预措施

Control Ring

Other

"Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse (Phase A)

干预措施: Penile Ring (Device)

1" RIng

Experimental

Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B)

干预措施: Penile Ring (Device)

1.5" Ring

Experimental

Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C)

干预措施: Penile Ring (Device)

2" Ring

Experimental

Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D)

干预措施: Penile Ring (Device)

结局指标

主要结局

Overall Sexual Pleasure on a Visual Analogue Scale

时间窗: Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks

Overall Sexual Pleasure on a Visual Analogue Scale between 0-100

次要结局

  • Sexual Pleasure from Intercourse on a Visual Analogue Scale(Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks)
  • Emotional Connection on a Visual Analogue Scale(Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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