Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 1" RIng | Experimental | Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B) |
|
| 1.5" Ring | Experimental | Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C) |
|
| 2" Ring | Experimental | Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penile Ring | Device | Penile Ring at base of penis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Sexual Pleasure on a Visual Analogue Scale | Overall Sexual Pleasure on a Visual Analogue Scale between 0-100 | Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Pleasure from Intercourse on a Visual Analogue Scale | Sexual pleasure from intercourse alone on a Visual Analogue Scale between 0-100 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Anxiety Disorders and Trauma | London | se5 8az | United Kingdom |
All original data
10 years
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010411 | Penile Induration |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Single Case Experimental Design
Not provided
Not provided
Masking of female participant
Emotional Connection on a Visual Analogue Scale between 0-100 |
| Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks |
| D052801 |
| Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |