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NCT Number: NCT07736560

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

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.

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Key information

About this study

Overactive bladder affects quality of life significantly and is managed with antimuscarinic agents that block M2 and M3 muscarinic receptors. M3 receptors mediate direct smooth muscle contraction via Gq protein and phospholipase C-induced calcium release, while M2 receptors modulate M3 activity indirectly via Gi protein and adenylyl cyclase inhibition.

Ejaculation consists of two phases: emission (peristaltic movement of seminal fluid from seminal vesicles and vas deferens into the prostatic urethra) and expulsion (forceful ejection from the urethra). Both M2 and M3 receptors have been identified in smooth muscle and epithelial cells of seminal vesicles in animal studies, suggesting a role in regulating peristaltic contractions during the emission phase.

This study hypothesizes that antimuscarinic drugs may prolong ejaculation duration by inhibiting peristaltic activity in the seminal vesicles and vas deferens via M2/M3 receptor blockade, thereby extending the emission phase.

Male patients aged 20-50 presenting with OAB symptoms and initiated on antimuscarinic therapy will be evaluated using IIEF, PEP, PEDT, and OAB-V8 questionnaires at baseline, 1 month, and 2 months. This is a purely observational study with no modification to standard clinical care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in Ejaculatory Function as Assessed by PEDT

    Time frame: Baseline, 1 month, and 2 months

    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.

Secondary outcomes

  1. Change in Overactive Bladder Symptoms as Assessed by OAB-V8

    Time frame: Baseline, 1 month, and 2 months

    Change in overactive bladder symptom severity from baseline to follow-up visits, evaluated using the OAB-V8 questionnaire.

    OAB-V8 (Overactive Bladder Questionnaire-V8) 8 questions, 0-5 points each, total 0-40. Score ≥8 indicates clinically significant OAB symptoms.

  2. Change in Erectile Function as Assessed by IIEF

    Time frame: Baseline, 1 month, and 2 months

    Change in erectile function scores from baseline to follow-up visits, evaluated using the International Index of Erectile Function (IIEF) questionnaire.

    IIEF-5 (SHIM - Sexual Health Inventory for Men) 5 questions, total score 5-25. Score ≥22: no ED; 17-21: mild; 12-16: mild-moderate; 8-11: moderate; 5-7: severe ED.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Evaluation of the Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Male Patients Treated for Overactive Bladder: An Observational Study

Acronym: ADEER

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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