Urinary IncontinenceNCT03587402
Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation
A study testing Transcutaneous perineal stimulation and Anal stimulation in people with Urinary Incontinence and Radical Prostatectomy, run by RAPbarcelona at 1 site in Spain.
Trial summary
This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy. Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Radical Prostatectomy, Pelvic Floor
- What is being tested?
- Transcutaneous perineal stimulation and Anal stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 6 Oct 2020
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having undergone a radical prostatectomy surgical procedure.
- Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)
- Do not exceed the year since the surgical intervention.
- Accept to participate in the study and grant signed informed consent.
Who cannot join
- Follow a pharmacological treatment for the UI.
- Presenting anatomical malformations of the pelvic floor musculature.
- Carry pacemaker.
- Present anal fistulas.
- suffer from serious psychic disorders.
- Presenting lower urinary tract infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy
This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.
Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.
Read the detailed description
Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.
The perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.
- Conditions
- Urinary Incontinence, Radical Prostatectomy, Pelvic Floor
- Being tested
- Transcutaneous perineal stimulation, Anal stimulation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous perineal stimulationOther
Surface stimulation
Anal stimulationOther
Intra-cavitary stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous perineal stimulation | Experimental | Patient is asked to lie down with legs slightly bend and two adhesive electrodes are attached transcutaneous on base of penis and on perineum. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks. Receives: Other: Transcutaneous perineal stimulation |
| Anal stimulation | Active comparator | Patient is asked to lie down with legs slightly bend and an electrical probe is inserted into the anus. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks. Receives: Other: Anal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of transcutaneous perineal stimulation compared to anal stimulation
A change of the urine grams last in 24 hours
Measured: Baseline, 6 and 10 weeks
Secondary outcomes (2)
Asses quality of life
Asses the perceived quality of life of patients in the study. It will be evaluated with the questionnaire I-QOL. It measures the effect of urinary incontinence on quality of life.
The I-QOL have 22 items and is divided into 3 subscales: avoidance and limiting behavior, psychosocial impact, social embarrassment. More puntuation means more quality of life.
Measured: Baseline and 10 weeks
Assess adverse effects
Identify adverse effects for each of the treatments
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Feb 2019
- Primary completion30 Jul 2019
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPbarcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Pané Alemany, RAPbarcelona
- Investigators
- Regina Pané, Principal investigator, RAPbarcelonaInés Ramírez, Study director, RAPbarcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587402
- Sponsor's protocol ID
- RAP47747176G
- Status last verified
- Oct 2020
- First submitted
- 27 Jun 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pane-Alemany R, Ramirez-Garcia I, Carralero-Martinez A, Blanco-Ratto L, Kauffmann S, Sanchez E. Efficacy of transcutaneous perineal electrostimulation versus intracavitary anal electrostimulation in the treatment of urinary incontinence after a radical prostatectomy: randomized controlled trial study protocol. BMC Urol. 2021 Jan 28;21(1):12. doi: 10.1186/s12894-020-00718-y.
PubMed 33509164
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03587402
- Acronym / sponsor ID
- RAP47747176G
- Conditions
- Urinary Incontinence, Radical Prostatectomy, Pelvic Floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- RAPbarcelonaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 16 Jul 2018 (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.
This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.
Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.
Detailed description
Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.
The perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous perineal stimulation | Experimental | Other: Transcutaneous perineal stimulationPatient is asked to lie down with legs slightly bend and two adhesive electrodes are attached transcutaneous on base of penis and on perineum. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks. |
| Anal stimulation | Active comparator | Other: Anal stimulationPatient is asked to lie down with legs slightly bend and an electrical probe is inserted into the anus. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having undergone a radical prostatectomy surgical procedure.
- Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)
- Do not exceed the year since the surgical intervention.
- Accept to participate in the study and grant signed informed consent.
Key exclusion criteria (6 listed)
- Follow a pharmacological treatment for the UI.
- Presenting anatomical malformations of the pelvic floor musculature.
- Carry pacemaker.
- Present anal fistulas.
- suffer from serious psychic disorders.
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 |
|---|---|---|
| Transcutaneous perineal stimulationSurface stimulation | Other | Transcutaneous perineal stimulation |
| Anal stimulationIntra-cavitary stimulation | Other | Anal stimulation |
Primary outcome
Effects of transcutaneous perineal stimulation compared to anal stimulation
Time frame: Baseline, 6 and 10 weeks
A change of the urine grams last in 24 hours
2 secondary outcomes
Asses quality of life
Time frame: Baseline and 10 weeks
Assess adverse effects
Time frame: 10 weeks
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 8 Oct 2020.
- Derived from this study: PubMed 33509164Pane-Alemany R, Ramirez-Garcia I, Carralero-Martinez A, Blanco-Ratto L, Kauffmann S, Sanchez E. Efficacy of transcutaneous perineal electrostimulation versus intracavitary anal electrostimulation in the treatment of urinary incontinence after a radical prostatectomy: randomized controlled trial study protocol. BMC Urol. 2021 Jan 28;21(1):12. doi: 10.1186/s12894-020-00718-y.
- 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.
Regina Pané principal investigator
RAPbarcelona
Inés Ramírez study director
RAPbarcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous perineal stimulation and Anal stimulation in people with Urinary Incontinence and Radical Prostatectomy, run by RAPbarcelona at 1 site in Spain.
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 6 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 8 Oct 2020. 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 Spain. 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?
Effects of transcutaneous perineal stimulation compared to anal stimulation (time frame: Baseline, 6 and 10 weeks). 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 NCT03587402, 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 8 Oct 2020.