Clinical Trials Logo

Clinical 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04052217
Study type Interventional
Source King's College London
Contact
Status Completed
Phase N/A
Start date March 1, 2017
Completion date August 1, 2019

See also
  Status Clinical Trial Phase
Completed NCT03774264 - Treatment Response to Xiaflex for Men With Peyronie's Disease
Recruiting NCT05777031 - Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease Phase 4
Active, not recruiting NCT05871177 - Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD) N/A
Recruiting NCT05768867 - French Translation and Validation of the PEYronie's Disease QUESTionnaire
Recruiting NCT04512287 - PRP for Treatment of Peyronie's Disease Phase 2
Withdrawn NCT05646602 - Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction N/A
Recruiting NCT03530540 - Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease. N/A
Recruiting NCT06303661 - Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease N/A
Recruiting NCT06065436 - Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease N/A
Recruiting NCT05316714 - Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment N/A
Completed NCT04370652 - Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum
Active, not recruiting NCT05480683 - Pelvic CT With Agatston Calcium Score for Peyronie Disease N/A
Recruiting NCT04821115 - Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease N/A