EndometriosisNCT04228692
Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery
A study testing Self-catheterization only and Posterior tibial nerve stimulation + self-catheterization in people with Endometriosis and Dysuria, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Symptomatic endometriosis can be responsible for urinary problems as well as symptoms of clinical bladder hyperactivity and/or symptoms of bladder pain before or during miction that can persist after bladder voiding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Dysuria
- What is being tested?
- Self-catheterization only and Posterior tibial nerve stimulation + self-catheterization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to 11 Jun 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are eligible for the French public healthcare system
- Patients who have given their consent for this research
Who cannot join
- Patients with cognitive, psychiatric or motor disturbances, that do not allow for independent use of the device
- Patients who do not speak French
- Patients who have had a surgery (bladder or ureters) for endometriosis or any other reason.
- Patients who were participating in another ongoing study, or within the exclusion time stipulated by another study (at the discretion of the investigator)
- Patients unable to give their consent (protected by law: under guardianship / trusteeship)
- Patients who are taking a pharmaceutical treatment for urological problem (anticholinergics, alpha-blockers, prostaglandin)
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- Pregnant or breastfeeding women
- Patients with a pacemaker
- Patients with dermatological problem in the area where the device's electrodes have to be installed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Benefits of Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery
Symptomatic endometriosis can be responsible for urinary problems as well as symptoms of clinical bladder hyperactivity and/or symptoms of bladder pain before or during miction that can persist after bladder voiding. Whereas urinary problems can predate surgery due to the endometrial lesions themselves, the surgery can also have functional consequences for urinary function, specifically when there is trauma (incisions, per-operative coagulation) to the inferior hypogastric nerve fibers and/or to the hypogastric plexus.
The incidence of post-surgery urinary symptoms could be as high as 30%. The incidence of voiding problems and specifically of non-obstructive voiding dysfunction can be observed in 17,5% of cases of patients 1-month post-surgery for deep colorectal endometriosis, and persists in 4,8% of women after 12 months.
Read more
The gold standard for treatment of voiding problems consists of self-catheterization, as is the case for all non-obstructive voiding dysfunction symptoms. This procedure considerably impacts quality of life. The proper and complete voiding of the bladder remains essential in order to avoid recurring urinary tract infections and pelvic static disorder.
In the case of persistent dysuria, the use of self-catheterization is necessary in 21% of patients after surgery for deep endometriosis, for an average duration of 85 days. To date, few studies have explored the management of post-operative urinary complications after surgery for deep endometriosis. Pharmaceutical alternatives (alpha-blockers, anticholinergics, benzodiazepines) have not proven effective and sometimes cause side effects. However promising alternative treatments are being developed, specifically the neuromodulation of the sacral root. This procedure has been shown effective in the treatment of non-obstructive voiding dysfunction; however, it remains an invasive treatment that has its load of complications and undesirable side-effects. A recent study reports favorable results for the use of sacral neuromodulation in the case of persistent incomplete voiding following surgery for deep colorectal endometriosis. Some studies have also suggested that percutaneous posterior tibial nerve stimulation (PTN) could also be a treatment alternative. The advantage of this procedure is that it is non-invasive and less constraining. No study has yet evaluated whether PTN could also be used to treat patients with persistent voiding dysfunction following surgery for deep endometriosis.
Our study, conducted in the gynecologic department of Croix ROUSSE Hospital, Lyon (France), evaluates PTN as a new treatment option for post-operative voiding dysfunction in women who suffer from deep endometriosis. Our aim is to prove that the use of PTN can reduce the duration of self-catheterization by 50% when compared to self-catheterization only.
- Conditions
- Endometriosis, Dysuria
- Being tested
- Self-catheterization only, Posterior tibial nerve stimulation + self-catheterization
- Keywords
- deep endometriosis surgery, voiding dysfunction, self-catheterization, posterior tibial nerve stimulation
- Medical subject headings
- Endometriosis, Dysuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-catheterization onlyProcedure or surgery
Patients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary.
Posterior tibial nerve stimulation + self-catheterizationDevice
Patients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary.
Patients will have 2 sessions per day of PTN (10-20 min) until self-catheterization is no longer necessary.
| Study group | Role | What they receive |
|---|---|---|
| Self-catheterization only | Active comparator | Patients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary Receives: Procedure: Self-catheterization only |
| Posterior tibial nerve stimulation + self-catheterization | Experimental | Patients self-catheterized after each micturition, noting each volume of spontaneous micturition and each volume obtained by self-catheterization.
Patients will have 2 sessions per day of PTN (10-20 min) until self-catheterization is no longer necessary. Receives: Device: Posterior tibial nerve stimulation + self-catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 50% of total duration of self-catheterization in the self-catheterization + PTN group
Comparison of total numbers of days of self-catheterization between the 2 groups
Measured: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Secondary outcomes (6)
Number of self-catheterizations per day
Patients will complete a voiding calendar as long as self-catheterization is required
Measured: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Post voiding residual urine volume (PVR)
Patients will complete a voiding calendar as long as self-catheterization is required
Measured: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
number of PVR> 50% of spontaneous miction
Patients will complete a voiding calendar as long as self-catheterization is required
Measured: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
side effects of PTN
sensation of small electrical discharges, skin reactions next to the electrodes will be notified by patients
Measured: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
number of sessions of PTN per week
Measured: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
duration of each session of PTN
Measured: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start11 Mar 2020
- Primary completion11 Jun 2022
- Study completion11 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie WAREMBOURG, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228692
- Sponsor's protocol ID
- 69HCL19_0686
- Other IDs
- 2019-A02583-54
- Status last verified
- Jul 2023
- First submitted
- 9 Jan 2020
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery
- ClinicalTrials.gov ID
- NCT04228692
- Acronym / sponsor ID
- 69HCL19_0686
- Conditions
- Endometriosis, Dysuria
- Keywords
- deep endometriosis surgery, voiding dysfunction, self-catheterization, posterior tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 14 Jan 2020 (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.
Symptomatic endometriosis can be responsible for urinary problems as well as symptoms of clinical bladder hyperactivity and/or symptoms of bladder pain before or during miction that can persist after bladder voiding. Whereas urinary problems can predate surgery due to the endometrial lesions themselves, the surgery can also have functional consequences for urinary function, specifically when there is trauma (incisions, per-operative coagulation) to the inferior hypogastric nerve fibers and/or to the hypogastric plexus.
The incidence of post-surgery urinary symptoms could be as high as 30%. The incidence of voiding problems and specifically of non-obstructive voiding dysfunction can be observed in 17,5% of cases of patients 1-month post-surgery for deep colorectal endometriosis, and persists in 4,8% of women after 12 months.
The gold standard for treatment of voiding problems consists of self-catheterization, as is the case for all non-obstructive voiding dysfunction symptoms. This procedure considerably impacts quality of life. The proper and complete voiding of the bladder remains essential in order to avoid recurring urinary tract infections and pelvic static disorder.
In the case of persistent dysuria, the use of self-catheterization is necessary in 21% of patients after surgery for deep endometriosis, for an average duration of 85 days. To date, few studies have explored the management of post-operative urinary complications after surgery for deep endometriosis. Pharmaceutical alternatives (alpha-blockers, anticholinergics, benzodiazepines) have not proven effective and sometimes cause side effects. However promising alternative treatments are being developed, specifically the neuromodulation of the sacral root. This procedure has been shown effective in the treatment of non-obstructive voiding dysfunction; however, it remains an invasive treatment that has its load of complications and undesirable side-effects. A recent study reports favorable results for the use of sacral neuromodulation in the case of persistent incomplete voiding following surgery for deep colorectal endometriosis. Some studies have also suggested that percutaneous posterior tibial nerve stimulation (PTN) could also be a treatment alternative. The advantage of this procedure is that it is non-invasive and less constraining. No study has yet evaluated whether PTN could also be used to treat patients with persistent voiding dysfunction following surgery for deep endometriosis.
Our study, conducted in the gynecologic department of Croix ROUSSE Hospital, Lyon (France), evaluates PTN as a new treatment option for post-operative voiding dysfunction in women who suffer from deep endometriosis. Our aim is to prove that the use of PTN can reduce the duration of self-catheterization by 50% when compared to self-catheterization only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-catheterization only | Active comparator | Procedure: Self-catheterization onlyPatients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary |
| Posterior tibial nerve stimulation + self-catheterization | Experimental | Device: Posterior tibial nerve stimulation + self-catheterizationPatients self-catheterized after each micturition, noting each volume of spontaneous micturition and each volume obtained by self-catheterization. Patients will have 2 sessions per day of PTN (10-20 min) until self-catheterization is no longer necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are eligible for the French public healthcare system
- Patients who have given their consent for this research
Key exclusion criteria (9 listed)
- Patients with cognitive, psychiatric or motor disturbances, that do not allow for independent use of the device
- Patients who do not speak French
- Patients who have had a surgery (bladder or ureters) for endometriosis or any other reason.
- Patients who were participating in another ongoing study, or within the exclusion time stipulated by another study (at the discretion of the investigator)
- Patients unable to give their consent (protected by law: under guardianship / trusteeship)
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 |
|---|---|---|
| Self-catheterization onlyPatients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary. | Procedure or surgery | Self-catheterization only |
| Posterior tibial nerve stimulation + self-catheterizationPatients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary. Patients will have 2 sessions per day of PTN (10-20 min) until self-catheterization is no longer necessary. | Device | Posterior tibial nerve stimulation + self-catheterization |
Primary outcome
Reduction of 50% of total duration of self-catheterization in the self-catheterization + PTN group
Time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Comparison of total numbers of days of self-catheterization between the 2 groups
6 secondary outcomes
Number of self-catheterizations per day
Time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Post voiding residual urine volume (PVR)
Time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
number of PVR> 50% of spontaneous miction
Time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
side effects of PTN
Time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
number of sessions of PTN per week
Time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 months
duration of each session of PTN
Time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 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 6 Jul 2023.
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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.
Sophie WAREMBOURG, Dr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-catheterization only and Posterior tibial nerve stimulation + self-catheterization in people with Endometriosis and Dysuria, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 9 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 6 Jul 2023. 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 France. 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?
Reduction of 50% of total duration of self-catheterization in the self-catheterization + PTN group (time frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 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 6 Jul 2023.