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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02583-54 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-catheterization only | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the day of surgery to the end of self-catheterization or until a maximum of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of self-catheterizations per day | Patients will complete a voiding calendar as long as self-catheterization is required | From the day of surgery to the end of self-catheterization or until a maximum of 3 months |
| Post voiding residual urine volume (PVR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie WAREMBOURG, Dr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse | Lyon | 69004 | France |
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| Posterior tibial nerve stimulation + self-catheterization | Device | 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. |
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Patients will complete a voiding calendar as long as self-catheterization is required |
| 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 | 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 | 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 | From the day of surgery to the end of self-catheterization or until a maximum of 3 months |
| duration of each session of PTN | From the day of surgery to the end of self-catheterization or until a maximum of 3 months |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D053159 | Dysuria |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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