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

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.

Study Overview

• Status: Completed
• Conditions: Peyronie Disease
• Intervention / Treatment: Device: Penile Ring

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AZ
    • Centre for Anxiety Disorders and Trauma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Penile Induration
• Other Study ID Numbers: HR-16/17-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All original data
• IPD Sharing Time Frame: 10 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No