Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Men With Overactive Bladder

NCT07736560 | Completed

• 1 other identifier: E-48670771-514.99-292152060
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) is a condition characterized by involuntary bladder contractions. Antimuscarinic drugs are commonly used to treat OAB by blocking muscarinic receptors (M2 and M3) in the bladder. These same receptors are also present in the seminal vesicles and vas deferens, which are structures involved in ejaculation. This observational study aims to evaluate whether antimuscarinic drugs used for OAB treatment have any effect on ejaculation duration and the refractory period in male patients. Male patients aged 20-50 who are prescribed antimuscarinic medication (tolterodine, propiverine) for OAB will complete validated questionnaires (IIEF, PEP, PEDT, OAB-V8) before starting treatment and at 1-month and 2-month follow-up visits. No changes will be made to the patients' standard treatment.

Conditions

Overactive Bladder (OAB); Premature (Early) Ejaculation; Ejaculation Abnormal

Outcome Measures

Primary Outcomes (1)

• Change in Ejaculatory Function as Assessed by PEDT

  Change in premature ejaculation severity from baseline to follow-up visits, evaluated using the Premature Ejaculation Diagnostic Tool (PEDT). PEDT (Premature Ejaculation Diagnostic Tool) 5 questions, 0-4 points each, total 0-20. Score ≤8: no PE, 9-10: borderline, ≥11: premature ejaculation.

  Baseline, 1 month, and 2 months

Secondary Outcomes (2)

• Change in Overactive Bladder Symptoms as Assessed by OAB-V8

  Baseline, 1 month, and 2 months

• Change in Erectile Function as Assessed by IIEF

  Baseline, 1 month, and 2 months

Study Arms (3)

Tolterodine Group

Male patients aged 20-50 with overactive bladder who are initiated on tolterodine as part of standard clinical care. Participants complete IIEF, PEP, PEDT, and OAB-V8 questionnaires at baseline, 1-month, and 2-month follow-up visits. No modification to standard treatment is performed.

Drug: Tolterodine

Propiverine Group

Male patients aged 20-50 with overactive bladder who are initiated on propiverine as part of standard clinical care. Participants complete IIEF, PEP, PEDT, and OAB-V8 questionnaires at baseline, 1-month, and 2-month follow-up visits. No modification to standard treatment is performed.

Drug: Propiverine tablet

Mirabegron

Male patients aged 20-50 with overactive bladder who are initiated on mirabegron as part of standard clinical care. Participants complete IIEF, PEP, PEDT, and OAB-V8 questionnaires at baseline, 1-month, and 2-month follow-up visits. No modification to standard treatment is performed.

Drug: Mirabegron (beta3-adrenoceptor agonist)

Interventions

Tolterodine DRUG

Tolterodine is a competitive muscarinic receptor antagonist with relative functional selectivity for the bladder. It is prescribed as standard clinical care for overactive bladder symptoms. Dose and formulation are determined by the treating physician per routine practice. No modification to the prescribed regimen is made within the scope of this observational study.

Tolterodine Group

Propiverine tablet DRUG

Propiverine is an antimuscarinic agent with additional calcium channel blocking properties, used for overactive bladder treatment. It is prescribed as standard clinical care. Dose and formulation are determined by the treating physician per routine practice. No modification to the prescribed regimen is made within the scope of this observational study.

Propiverine Group

Mirabegron (beta3-adrenoceptor agonist) DRUG

Mirabegron is a beta-3 adrenergic receptor agonist used for overactive bladder treatment. Unlike antimuscarinic agents, it does not block muscarinic receptors. It is included in this study as a comparison group to evaluate whether ejaculatory effects are specific to muscarinic receptor blockade. Prescribed as standard clinical care with no modification to treatment.

Mirabegron

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male patients aged 20-50 presenting to our urology outpatient clinic with overactive bladder symptoms and initiated on antimuscarinic therapy or mirabegron as part of routine clinical care

You may qualify if:

• Male patients aged 20-50 years
• Diagnosis of overactive bladder (OAB) confirmed clinically
• Sexually active
• Willing to complete questionnaires at all three time points

You may not qualify if:

• Previous use of antimuscarinic or beta-3 agonist medications
• Neurological disorders affecting bladder or sexual function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury)
• Prior pelvic surgery or radiotherapy
• Use of medications known to affect ejaculatory function (e.g., alpha-blockers, SSRIs, antipsychotics)
• Active urinary tract infection
• Uncontrolled diabetes mellitus
• Unwillingness to participate

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital, Department of Urology

Istanbul, Istanbul, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Premature Birth

Interventions

Tolterodine Tartrate; propiverine; mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Veysel Sezgin

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: January 15, 2026
• Primary Completion: June 20, 2026
• Study Completion: June 30, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)