Overactive Bladder (OAB)NCT07736560
Effect of Antimuscarinic Treatment on Premature Ejaculation Severity in Men With Overactive Bladder: a Prospective Comparison With Mirabegron
An observational study of Overactive Bladder (OAB) and Premature (Early) Ejaculation, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Overactive Bladder (OAB), Premature (Early) Ejaculation, Ejaculation Abnormal
- What is being tested?
- Tolterodine and Mirabegron (beta3-adrenoceptor agonist)
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
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
Who may be able to join
- Male patients aged 20-50 years
- Diagnosis of overactive bladder (OAB) confirmed clinically
- Sexually active
- Willing to complete questionnaires at all three time points
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital, Department of Urology
Istanbul, Istanbul, 34200
About this study
Official title: Evaluation of the Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Male Patients Treated for Overactive Bladder: An Observational Study
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.
Read the detailed description
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.
- Being tested
- Tolterodine, Mirabegron (beta3-adrenoceptor agonist)
- Medical subject headings
- Urinary Bladder, Overactive, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolterodineDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tolterodine | |
| 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. Receives: Drug: Mirabegron (beta3-adrenoceptor agonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, and 2 months
Secondary outcomes (1)
Change in Overactive Bladder Symptoms as Assessed by OAB-V8
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.
Measured: Baseline, 1 month, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Jan 2026
- Primary completion20 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SEZGIN, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736560
- Sponsor's protocol ID
- E-48670771-514.99-292152060
- Status last verified
- Apr 2026
- First submitted
- 26 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Male Patients Treated for Overactive Bladder: An Observational Study
- ClinicalTrials.gov ID
- NCT07736560
- Acronym / sponsor ID
- E-48670771-514.99-292152060
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolterodine Group | – | Drug: TolterodineMale 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. |
| Mirabegron | – | Drug: Mirabegron (beta3-adrenoceptor agonist)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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Male patients aged 20-50 years
- Diagnosis of overactive bladder (OAB) confirmed clinically
- Sexually active
- Willing to complete questionnaires at all three time points
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolterodineTolterodine 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. | Drug | Tolterodine Group |
| Mirabegron (beta3-adrenoceptor agonist)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. | Drug | Mirabegron |
Primary outcome
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.
1 secondary outcome
Change in Overactive Bladder Symptoms as Assessed by OAB-V8
Time frame: Baseline, 1 month, and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder (OAB) and Premature (Early) Ejaculation, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ejaculatory Function as Assessed by PEDT (time frame: Baseline, 1 month, and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.