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

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.

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 Overview

• Status: Completed
• Conditions: Endometriosis; Dysuria
• Intervention / Treatment: Procedure: Self-catheterization only; Device: Posterior tibial nerve stimulation + self-catheterization

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie WAREMBOURG, Dr; Phone Number: +33 4.72.07.19.36; Email: sophie.warembourg@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Hopital de la Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sophie WAREMBOURG, Dr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Actual): June 11, 2022
• Study Completion (Actual): June 11, 2022

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: posterior tibial nerve stimulation; voiding dysfunction; deep endometriosis surgery; self-catheterization
• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis; Dysuria
• Other Study ID Numbers: 69HCL19_0686; 2019-A02583-54 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No