CLIMACS (CLinical efficacy and systemic Improvements for MAnagement of premature ejaCulation Symptoms using a digital application)
Organizational Data
- DRKS-ID:
- DRKS00032774
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-09-29
- Last update in DRKS:
- 2023-11-13
- Registration type:
- Prospective
Acronym/abbreviation of the study
CLIMACS
URL of the study
https://de.melonga.com/climacs-studie/
Brief summary in lay language
The aim of the study is to determine the benefit of a digital intervention - the Melonga medical app - for better management of the symptoms of premature ejaculation (PE). The study aims to investigate the effects of a digital app-based intervention on PE symptoms and quality of life of PE patients.
Brief summary in scientific language
This study aims to determine the usefulness of a digital intervention - the Melonga medical app - for better management of the symptoms of premature ejaculation (ICD-10: F52.4). PE is a highly stigmatized illness that affects up to 30% of all men. Despite the high level of suffering and sometimes severe psychological impairment, those affected rarely seek advice in a clinic or urological practice due to the social stigma. In the Premature Ejaculation Prevalence and Attitudes (PEPA) survey, only 9% of men with self-reported PE consulted a doctor. Doctors often feel uncomfortable discussing sexuality with their patients, usually due to embarrassment and a lack of training or expertise in treating EP. The primary therapies recommended today according to the EAU guidelines are drug treatment with the active ingredient dapoxetine or psychotherapy. Despite their proven effectiveness, both treatment options have disadvantages: With medication, the pill must be taken one to three hours before sexual intercourse. In addition, treatment with dapoxetine very often leads to side effects such as nausea, headaches and dizziness. Psychotherapeutic consultation is comparatively time-consuming and not always easy to integrate into the patient's everyday life. In addition, the availability of therapists varies greatly from region to region and is not universal. Given the limitations of current means of treatments, the aim of this study is to evaluate clinical effectiveness of Melonga, a new digital app-based intervention for alleviating symptoms of premature ejaculation. The Melonga app offers patients non-drug and self-directed treatment of praecox ejaculation symptoms in the privacy of their own home through cognitive behavioral therapy methods. The Melonga app is a medical product (Class I according to MDR). The study is the first to examine the clinical and social value of a digital app-based intervention for the management of PE. The expected benefits of the intervention examined in this study are: 1) Improvement in premature ejaculation symptoms in patients 2) Improve patients' quality of life 3) Improving patients' sexual intimacy and improving their relationship with their partner. 4) Improve awareness of their medical condition, access to care and participation
Health condition or problem studied
- ICD10:
- F52.4 - Premature ejaculation
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Group B will receive access to the Melonga app for 12 weeks at t=0.
- Arm 2:
- Group A serves as a control group for 12 weeks and then receives the app between weeks 13 and 24
Endpoints
- Primary outcome:
- Improvement (increase) in PEP score by at least 2 points compared to a control group
- Secondary outcome:
- 1. General sexual function (measured with the IIEF-15 questionnaire) 2. Sexual quality of life (measured with the SQoL-M questionnaire) 3. Patient activation (measured by the PAM-13 questionnaire) 4. Improving access to medical care through digital tools (measured by the Acceptability E-scale) 5. Self-reported IELT (Intravaginal Ejaculation Latency) + two self-formulated questions on the patient reported outcome (PRO) 6. PHQ-4 questionnaire 7. PEDT questionnaire
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Randomization is carried out centrally by the KKS Marburg. The chance of being assigned to Group A or Group B is 1:1
- Blinding:
- No
- Assignment:
- Crossover
- Sequence generation:
- Group B will receive access to the Melonga app for 12 weeks at t=0. Group A will serve as a control group for 12 weeks and then receive the app between week 13 and week 24. Both groups will be asked to complete questionnaires at the scheduled time points and follow-up 12 weeks after the end of the Melonga program.
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Urologie der Universitätsklinik der Philipps-Universität Marburg Marburg
Recruitment period and number of participants
- Planned study start date:
- 2023-09-29
- Actual study start date:
- 2023-10-19
- Planned study completion date:
- 2024-07-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 80
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Male
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1) PEDT score > 9 2) male, at least 18 years old 3) Sexually active with a partner at the time of recruitment (both temporary and permanent partners are acceptable) 4) Owns a smartphone and is familiar with iOS or Android smartphones. 5) Generally good health (both physical and mental), which will be documented in the anamnesis interview with the investigator. 6) Can speak and read German or English very well 7) Available for the duration of the study 8) Willingness to wait possibly 3 months before starting the intervention 9) Submission of a dated and signed informed consent form
Exclusion Criteria
1) Previous treatment with another preparation or intervention for EP within the last three months 2) Presence of sexual dysfunction other than EP (specifically erectile dysfunction with a current IIEF-5 < 22) . 3) Initiated treatment of sexual dysfunction other than EP in the last 4 weeks or intending to do so in the next 6 months. 4) History of symptoms of prostatitis or active inflammation in the urogenital area. 5) Psychiatric diseases requiring treatment with antidepressants from the SSRI group. 6) Physical function or mental impairment that prevents the participant from performing or understanding the required tasks of the study or completing the questionnaires. 7) Rejection of the study
Addresses
Primary Sponsor
- Address:
- Prognoix Health BVAbhinav JainOxfordlaan 556229 EV MaastrichtNetherlands
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://prognoix.com/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Urologische Klinik der Universitätsklinik der Philipps-Universität MarburgPD. Dr. med. Christer GroebenBaldingerstrasse35043 MarburgGermany
- Telephone:
- +49064215862479
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukgm.de/ugm_2/deu/umr_uro/index.html
Contact for Public Queries
- Address:
- Urologische Klinik der Universitätsklinik der Philipps-Universität MarburgPD. Dr. med. Christer GroebenBaldingerstrasse35043 MarburgGermany
- Telephone:
- +49064215862479
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukgm.de/ugm_2/deu/umr_uro/index.html
Principal Investigator
- Address:
- Urologische Klinik der Universitätsklinik der Philipps-Universität MarburgPD. Dr. med. Christer GroebenBaldingerstrasse35043 MarburgGermany
- Telephone:
- +49064215862479
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.ukgm.de/ugm_2/deu/umr_uro/index.html
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Prognoix Health BVOxfordlaan 556229 EV MaastrichtNetherlands
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://prognoix.com/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin der Philipps-Universität MarburgBaldingerstraße35043 MarburgGermany
- Telephone:
- +49-6421-5866487
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-marburg.de/de/fb20/fachbereich/gremien/ethik
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-11-09
- Ethics committee number:
- 164/22
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-07-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- Kongresspräsentation durch PD Dr. Groeben, 76. Kongress der Dt. Gesellschaft für Urologie Sept. 2024 in Leipzig
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry