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Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228692
Recruitment Status : Not yet recruiting
First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Endometriosis Dysuria Procedure: Self-catheterization only Device: Posterior tibial nerve stimulation + self-catheterization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Benefits of Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Self-catheterization only
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
Procedure: Self-catheterization only
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.

Experimental: Posterior tibial nerve stimulation + self-catheterization

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.

Device: Posterior tibial nerve stimulation + self-catheterization

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Patients will complete a voiding calendar as long as self-catheterization is required

  2. 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 ]
    Patients will complete a voiding calendar as long as self-catheterization is required

  3. 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 ]
    Patients will complete a voiding calendar as long as self-catheterization is required

  4. side effects of PTN [ Time Frame: From the day of surgery to the end of self-catheterization or until a maximum of 3 months ]
    sensation of small electrical discharges, skin reactions next to the electrodes will be notified by patients

  5. 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 ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are eligible for the French public healthcare system
  • Patients who have given their consent for this research

Exclusion Criteria:

  • 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)
  • Pregnant or breastfeeding women
  • Patients with a pacemaker
  • Patients with dermatological problem in the area where the device's electrodes have to be installed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228692


Contacts
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Contact: Sophie WAREMBOURG, Dr 4.72.07.19.36 ext +33 sophie.warembourg@chu-lyon.fr

Locations
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France
Hôpital de la Croix Rousse
Lyon, France, 69004
Contact: Sophie WAREMBOURG, Dr    4.72.07.19.36 ext +33    sophie.warembourg@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sophie WAREMBOURG, Dr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04228692    
Other Study ID Numbers: 69HCL19_0686
2019-A02583-54 ( Other Identifier: ANSM )
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
deep endometriosis surgery
voiding dysfunction
self-catheterization
posterior tibial nerve stimulation
Additional relevant MeSH terms:
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Endometriosis
Dysuria
Genital Diseases, Female
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms