Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
Primary Purpose
Peyronie Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Penile Ring
Sponsored by
About this trial
This is an interventional other trial for Peyronie Disease
Eligibility Criteria
Inclusion Criteria:
- Heterosexual couples in a stable relationship (defined as 6 months or more)
- Having regular intercourse (defined as on average twice a week).
Exclusion Criteria:
- Any current sexual dysfunction in either partner
- Any current emotional disorder in either partner
- Men with a micro-penis
Sites / Locations
- Centre for Anxiety Disorders and Trauma
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Experimental
Experimental
Experimental
Arm Label
Control Ring
1" RIng
1.5" Ring
2" Ring
Arm Description
"Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse (Phase A)
Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B)
Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C)
Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D)
Outcomes
Primary Outcome Measures
Overall Sexual Pleasure on a Visual Analogue Scale
Overall Sexual Pleasure on a Visual Analogue Scale between 0-100
Secondary Outcome Measures
Sexual Pleasure from Intercourse on a Visual Analogue Scale
Sexual pleasure from intercourse alone on a Visual Analogue Scale between 0-100
Emotional Connection on a Visual Analogue Scale
Emotional Connection on a Visual Analogue Scale between 0-100
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04052217
Brief Title
Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
Official Title
Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
Phase A "Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse)
Phase B - 1" ring randomised to either 3, 4, or 5 episodes of intercourse)
Phase C - 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse)
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.
Measures:
The investigators will use a Visual Analogue Scale (0-100) for the female participant ratings of (a) sexual pleasure and (b) how emotionally connected she felt to her partner (c) any adverse experiences.
The female participant will be asked to rate the degree of change (positive or negative) that would be significant for them e.g. a drop of rating 65 to 45) The female participant will be asked to rate satisfaction and emotional closeness as soon as possible after intercourse. The investigators will ask all participants to enter the data directly onto web based capture of data. This will be anonymized so that they will be identified by a character.
The male participant will be asked to confirm the size of the ring used and any other comments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single Case Experimental Design
Masking
Participant
Masking Description
Masking of female participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Ring
Arm Type
Other
Arm Description
"Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse (Phase A)
Arm Title
1" RIng
Arm Type
Experimental
Arm Description
Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B)
Arm Title
1.5" Ring
Arm Type
Experimental
Arm Description
Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C)
Arm Title
2" Ring
Arm Type
Experimental
Arm Description
Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D)
Intervention Type
Device
Intervention Name(s)
Penile Ring
Intervention Description
Penile Ring at base of penis
Primary Outcome Measure Information:
Title
Overall Sexual Pleasure on a Visual Analogue Scale
Description
Overall Sexual Pleasure on a Visual Analogue Scale between 0-100
Time Frame
Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
Secondary Outcome Measure Information:
Title
Sexual Pleasure from Intercourse on a Visual Analogue Scale
Description
Sexual pleasure from intercourse alone on a Visual Analogue Scale between 0-100
Time Frame
Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
Title
Emotional Connection on a Visual Analogue Scale
Description
Emotional Connection on a Visual Analogue Scale between 0-100
Time Frame
Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Heterosexual couples in a stable relationship (defined as 6 months or more)
Having regular intercourse (defined as on average twice a week).
Exclusion Criteria:
Any current sexual dysfunction in either partner
Any current emotional disorder in either partner
Men with a micro-penis
Facility Information:
Facility Name
Centre for Anxiety Disorders and Trauma
City
London
ZIP/Postal Code
se5 8az
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All original data
IPD Sharing Time Frame
10 years
Learn more about this trial
Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
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