Peyronie DiseaseNCT04052217
Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
A study testing Penile Ring in people with Peyronie Disease, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- Penile Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Heterosexual couples in a stable relationship (defined as 6 months or more)
- Having regular intercourse (defined as on average twice a week).
Who cannot join
- Any current sexual dysfunction in either partner
- Any current emotional disorder in either partner
- Men with a micro-penis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Anxiety Disorders and Trauma
London, se5 8az
About this study
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.
Read the 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.
- Conditions
- Peyronie Disease
- Being tested
- Penile Ring
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile RingDevice
Penile Ring at base of penis
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Penile Ring |
| 1" RIng | Experimental | Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B) Receives: Device: Penile Ring |
| 1.5" Ring | Experimental | Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C) Receives: Device: Penile Ring |
| 2" Ring | Experimental | Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D) Receives: Device: Penile Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Sexual Pleasure on a Visual Analogue Scale
Overall Sexual Pleasure on a Visual Analogue Scale between 0-100
Measured: Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
Secondary outcomes (2)
Sexual Pleasure from Intercourse on a Visual Analogue Scale
Sexual pleasure from intercourse alone on a Visual Analogue Scale between 0-100
Measured: 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
Measured: Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Mar 2017
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single Case Experimental Design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052217
- Sponsor's protocol ID
- HR-16/17-2018
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All original data
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
- ClinicalTrials.gov ID
- NCT04052217
- Acronym / sponsor ID
- HR-16/17-2018
- Conditions
- Peyronie Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Single Case Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Control Ring | Other | Device: Penile Ring"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 | Device: Penile RingIntercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B) |
| 1.5" Ring | Experimental | Device: Penile RingIntercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C) |
| 2" Ring | Experimental | Device: Penile RingIntercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D) |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heterosexual couples in a stable relationship (defined as 6 months or more)
- Having regular intercourse (defined as on average twice a week).
Key exclusion criteria (3 listed)
- Any current sexual dysfunction in either partner
- Any current emotional disorder in either partner
- Men with a micro-penis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penile RingPenile Ring at base of penis | Device | 1" RIng, 1.5" Ring, 2" Ring, Control Ring |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: Yes. All original data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penile Ring in people with Peyronie Disease, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.