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

Primary Purpose

Endometriosis, Dysuria

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self-catheterization only
Posterior tibial nerve stimulation + self-catheterization
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring deep endometriosis surgery, voiding dysfunction, self-catheterization, posterior tibial nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Self-catheterization only

Posterior tibial nerve stimulation + self-catheterization

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of self-catheterizations per day
Patients will complete a voiding calendar as long as self-catheterization is required
Post voiding residual urine volume (PVR)
Patients will complete a voiding calendar as long as self-catheterization is required
number of PVR> 50% of spontaneous miction
Patients will complete a voiding calendar as long as self-catheterization is required
side effects of PTN
sensation of small electrical discharges, skin reactions next to the electrodes will be notified by patients
number of sessions of PTN per week
duration of each session of PTN

Full Information

First Posted
January 9, 2020
Last Updated
July 5, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04228692
Brief Title
Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery
Official Title
Evaluation of the Benefits of Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
June 11, 2022 (Actual)
Study Completion Date
June 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Dysuria
Keywords
deep endometriosis surgery, voiding dysfunction, self-catheterization, posterior tibial nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-catheterization only
Arm Type
Active Comparator
Arm Description
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
Arm Title
Posterior tibial nerve stimulation + self-catheterization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Self-catheterization only
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Posterior tibial nerve stimulation + self-catheterization
Intervention Description
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 Measure Information:
Title
Reduction of 50% of total duration of self-catheterization in the self-catheterization + PTN group
Description
Comparison of total numbers of days of self-catheterization between the 2 groups
Time Frame
From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Secondary Outcome Measure Information:
Title
Number of self-catheterizations per day
Description
Patients will complete a voiding calendar as long as self-catheterization is required
Time Frame
From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Title
Post voiding residual urine volume (PVR)
Description
Patients will complete a voiding calendar as long as self-catheterization is required
Time Frame
From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Title
number of PVR> 50% of spontaneous miction
Description
Patients will complete a voiding calendar as long as self-catheterization is required
Time Frame
From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Title
side effects of PTN
Description
sensation of small electrical discharges, skin reactions next to the electrodes will be notified by patients
Time Frame
From the day of surgery to the end of self-catheterization or until a maximum of 3 months
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie WAREMBOURG, Dr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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