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

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ClinicalTrials.gov Identifier: NCT04052217
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment Phase
Peyronie Disease Device: Penile Ring Not Applicable

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

  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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single Case Experimental Design
Masking: Single (Participant)
Masking Description: Masking of female participant
Primary Purpose: Other
Official Title: Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : August 1, 2019

Arm Intervention/treatment
Control Ring
"Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse (Phase A)
Device: Penile Ring
Penile Ring at base of penis

Experimental: 1" RIng
Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B)
Device: Penile Ring
Penile Ring at base of penis

Experimental: 1.5" Ring
Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C)
Device: Penile Ring
Penile Ring at base of penis

Experimental: 2" Ring
Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D)
Device: Penile Ring
Penile Ring at base of penis




Primary Outcome Measures :
  1. Overall Sexual Pleasure on a Visual Analogue Scale [ Time Frame: 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


Secondary Outcome Measures :
  1. Sexual Pleasure from Intercourse on a Visual Analogue Scale [ Time Frame: Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks ]
    Sexual pleasure from intercourse alone on a Visual Analogue Scale between 0-100

  2. Emotional Connection on a Visual Analogue Scale [ Time Frame: 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 between 0-100



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any current sexual dysfunction in either partner
  2. Any current emotional disorder in either partner
  3. Men with a micro-penis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052217


Locations
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United Kingdom
Centre for Anxiety Disorders and Trauma
London, United Kingdom, se5 8az
Sponsors and Collaborators
King's College London

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04052217    
Other Study ID Numbers: HR-16/17-2018
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All original data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 10 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases