A randomized pilot study on the feasibility and efficacy of cognitive behavioural sex therapy (CBT-sex) as an adjunct short-term intervention for Peyronie’s disease

A randomized pilot study on the feasibility and efficacy of cognitive behavioural sex therapy (CBT-sex) as an adjunct short-term intervention for Peyronie’s disease - Cognitive behavioural sex therapy in Peyronie’s disease (CBT-Sex in PD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032190

Enrollment

Registered

2023-07-03

Start date

2023-07-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N48.6

Interventions

Group 1: The CBT+ group receives weekly one session of cognitive behavioral sex therapy for 6 weeks (50 minutes per session) in addition to treatment as usual Group 2: The CBT- group does not receive

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: PD diagnosis

Exclusion criteria

Exclusion criteria: • Male patients <18 years • patients with cognitive impairment • patients with psychiatric illness • no knowledge of the German language • patients with prior surgical IPP treatment

Design outcomes

Primary

Measure	Time frame
Co-primary endpoints: 1) Feasibility of CBT as an additional intervention to IPP. The feasibility is defined as the percentage of patients randomized to the CBT arm who fully complete the CBT protocol (do not miss more than one CBT session). 2) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in PDQ bother score. 3) Clinical improvement in PDQ bother score at 20 weeks after randomization, defined as a change of at least -2.2 points relative to baseline (i.e. pre-randomization).	—

Measure

Time frame

Co-primary endpoints: 1) Feasibility of CBT as an additional intervention to IPP. The feasibility is defined as the percentage of patients randomized to the CBT arm who fully complete the CBT protocol (do not miss more than one CBT session). 2) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in PDQ bother score. 3) Clinical improvement in PDQ bother score at 20 weeks after randomization, defined as a change of at least -2.2 points relative to baseline (i.e. pre-randomization).

—

Secondary

Measure	Time frame
1) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the PDQ psychological and physical symptoms score. 2) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the PDQ penile pain score. 3) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the NSSS-SF score. 4) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the IIEF-EF score.	—

Measure

Time frame

1) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the PDQ psychological and physical symptoms score. 2) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the PDQ penile pain score. 3) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the NSSS-SF score. 4) Absolute change from baseline (i.e. pre-randomization) to 20 weeks after randomization in the IIEF-EF score.

—

Countries

Germany

Contacts

Public ContactArmin Soave

Klinik und Poliklinik für Urologie, Universitätsklinikum Hamburg-Eppendorf

a.soave@uke.de+4940741053445

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026