Brief Summary

Aim of this research is to compare novel 3D printed cycling saddle with the bestselling saddles from two major cycling manufacturers in terms of effects on penile blood gasses and update these findings on current style of racing cycling saddles.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable healthy

Timeline

Completed

Started Apr 2023

Shorter than P25 for not_applicable healthy

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

23 days study duration

First Submitted

Initial submission to the registry

April 21, 2023

Completed

Same day until next milestone

Study Start

First participant enrolled

April 21, 2023

Completed

23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2023

Completed

19 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

23 days

First QC Date

April 21, 2023

Last Update Submit

December 24, 2025

Conditions

Healthy Cyclists Blood Gas Monitoring, Transcutaneous Penile Numbness

Keywords

saddlepressurebicyclingerectile dysfunctionhypesthesiatranscutaneous blood gas monitoringbike fitbiothesiometry

Outcome Measures

Primary Outcomes (2)

pO2_change_point
Parameter pO2\_change\_point is the time from start of TcPO₂ measurement to the identified change point, determined within the 50-400 s interval as the transition between the fitted initial linear trend and the subsequent linear trend in TcPO₂
During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pCO2_change_point
Parameter pCO2\_change\_point is the time from start of TcPCO₂ measurement to the identified change point, determined within the 200-550 s interval as the transition between the fitted initial linear trend and the subsequent linear trend in TcPCO₂
During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).

Secondary Outcomes (24)

pO2_start
During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_decline
During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_end
During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part1
During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
pO2_part2
During a single laboratory visit consisting of three 10-minute cycling intervals with three 5-minute pause time in between cycling intervals (total assessment time approximately 45 minutes).
+19 more secondary outcomes