Urinary Incontinence, StressPhase 1NCT03102645
Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
A Phase 1 study testing Imipramine Hydrochloride 25 MG in people with Urinary Incontinence, Stress and Fecal Incontinence, run by Jonatan Kornholt at 1 site in Denmark.
Trial summary
A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg. Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Stress, Fecal Incontinence
- What is being tested?
- Imipramine Hydrochloride 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 16 May 2017to 21 Jun 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed consent form.
- Healthy.
- Female.
- Non-smoker.
- Age 18 to 55, both inclusive.
- Normal weight: BMI 19.5 to 30.0 kg/m2. Weight minimum 50 kg.
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- No breastfeeding.
- No pregnancy during the study.
- No other clinical trials during the study.
Who cannot join
- Known allergy to imipramine or any of the other known constituents.
- Medical history with significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, genitourologic, dermatologic, psychiatric, neurologic or dermatologic disease, lung disease, kidney disease, malignant disease or other significant diseases as assessed by the investigator.
- Medical history of urinary incontinence.
- Infectious disease 1 week prior to study day 1 or study day 2.
- Clinically significant findings during the physical examination.
- Pregnancy.
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- Heart rate < 40 or > 100 beats per minute. Mean systolic blood pressure > 140 mmHg or mean diastolic blood pressure > 90 mmHg (mean of the measures on the screening day).
- Prescription, over the counter or herbal medication two weeks prior to study day 1 or study day 2. Excluding paracetamol and excluding oral contraceptives.
- Smoking 3 months prior to study day 1 or study day 2.
- Alcohol abuse, meaning > 14 units (12 g alcohol) per week within three weeks prior to study day 1 or study day 2.
- Drug abuse 3 months prior to study day 1 or study day 2.
- Any condition as assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital
Copenhagen, Copenhagen NV, 2400
About this study
Official title: Effect of Single Dose Imipramine on the Urethral and Anal Sphincter in Healthy Women Measured With Urethral Pressure Reflectometry (UPR) and Anal Acoustic Reflectometry (AAR)
A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg.
Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP increases correlate with effect in treating stress urinary incontinence. Can imipramine treat stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The investigators also wish to establish the within-subject standard deviation for AAR to enable power calculations in future studies.
- Conditions
- Urinary Incontinence, Stress, Fecal Incontinence
- Being tested
- Placebo Oral Tablet, Imipramine Hydrochloride 25 MG
- Medical subject headings
- Urinary Incontinence, Stress, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDrug
Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
Imipramine Hydrochloride 25 MGDrug
Also called Imipramin DAK
Two Imipramin DAK film coated tablets 25 mg each, single dose
| Study group | Role | What they receive |
|---|---|---|
| Imipramine first | Experimental | A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2 Receives: Drug: Placebo Oral Tablet; Drug: Imipramine Hydrochloride 25 MG |
| Placebo first | Experimental | A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2 Receives: Drug: Placebo Oral Tablet; Drug: Imipramine Hydrochloride 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral Opening Pressure (UOP)
Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
Measured: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Secondary outcomes (1)
Anal Opening Pressure (AOP)
Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).
Measured: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start16 May 2017
- Primary completion16 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 16 healthy female subjects. Double-blinded, crossover study on two days with 1 week washout. Either placebo or imipramine 50 mg single dose before and after measurement of UOP and AOP.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonatan Kornholt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonatan Kornholt, Bispebjerg Hospital
- Investigators
- Jonatan Kornholt, MD, Principal investigator, Klinisk farmakologisk afdeling, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102645
- Sponsor's protocol ID
- TCA-UPR-0001
- Status last verified
- Jan 2021
- First submitted
- 20 Mar 2017
- Last updated
- 12 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christoffersen T, Kornholt J, Riis T, Sonne DP, Klarskov N. Effect of Single-Dose Imipramine on Anal Sphincter Tone in Healthy Women: A Randomized, Placebo-Controlled Study Using Anal Acoustic Reflectometry. Int Urogynecol J. 2024 Sep;35(9):1873-1879. doi: 10.1007/s00192-024-05890-5. Epub 2024 Aug 21.
PubMed 39167201
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Dose Imipramine on the Urethral and Anal Sphincter in Healthy Women Measured With Urethral Pressure Reflectometry (UPR) and Anal Acoustic Reflectometry (AAR)
- ClinicalTrials.gov ID
- NCT03102645
- Acronym / sponsor ID
- TCA-UPR-0001
- Conditions
- Urinary Incontinence, Stress, Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jonatan KornholtUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 12 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg.
Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP increases correlate with effect in treating stress urinary incontinence. Can imipramine treat stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The investigators also wish to establish the within-subject standard deviation for AAR to enable power calculations in future studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 16 healthy female subjects. Double-blinded, crossover study on two days with 1 week washout. Either placebo or imipramine 50 mg single dose before and after measurement of UOP and AOP.
| Arm | Type | Receives |
|---|---|---|
| Imipramine first | Experimental | Drug: Placebo Oral Tablet, Drug: Imipramine Hydrochloride 25 MGA: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2 |
| Placebo first | Experimental | Drug: Placebo Oral Tablet, Drug: Imipramine Hydrochloride 25 MGA: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed consent form.
- Healthy.
- Female.
- Non-smoker.
- Age 18 to 55, both inclusive.
Key exclusion criteria (12 listed)
- Known allergy to imipramine or any of the other known constituents.
- Medical history with significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, genitourologic, dermatologic, psychiatric, neurologic or dermatologic disease, lung disease, kidney disease, malignant disease or other significant diseases as assessed by the investigator.
- Medical history of urinary incontinence.
- Infectious disease 1 week prior to study day 1 or study day 2.
- Clinically significant findings during the physical examination.
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 |
|---|---|---|
| Placebo Oral TabletPlacebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc | Drug | Imipramine first, Placebo first |
| Imipramine Hydrochloride 25 MGAlso: Imipramin DAKTwo Imipramin DAK film coated tablets 25 mg each, single dose | Drug | Imipramine first, Placebo first |
Primary outcome
Urethral Opening Pressure (UOP)
Time frame: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
1 secondary outcome
Anal Opening Pressure (AOP)
Time frame: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39167201Christoffersen T, Kornholt J, Riis T, Sonne DP, Klarskov N. Effect of Single-Dose Imipramine on Anal Sphincter Tone in Healthy Women: A Randomized, Placebo-Controlled Study Using Anal Acoustic Reflectometry. Int Urogynecol J. 2024 Sep;35(9):1873-1879. doi: 10.1007/s00192-024-05890-5. Epub 2024 Aug 21.
- 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.
Jonatan Kornholt, MD principal investigator
Klinisk farmakologisk afdeling, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imipramine Hydrochloride 25 MG in people with Urinary Incontinence, Stress and Fecal Incontinence, run by Jonatan Kornholt at 1 site in Denmark.
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 9 inclusion and 12 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 12 Feb 2021. 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urethral Opening Pressure (UOP) (time frame: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102645, which also lists 1 linked publication.
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 12 Feb 2021.