NCT04228692

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

Completed NA Last updated 6 July 2023

What this trial tests

NA trial testing Self-catheterization only in Endometriosis in 4 participants. Completed in 11 June 2022.

Timeline

11 March 2020

Primary endpoint
11 June 2022

11 June 2022

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	11 March 2020
Primary completion	11 June 2022
Estimated completion	11 June 2022
Sites	1 location across France

Drugs / interventions tested

• Self-catheterization only
• Posterior tibial nerve stimulation + self-catheterization

Conditions studied

• Endometriosis — all drugs for Endometriosis →
• Dysuria — all drugs for Dysuria →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, female only, with Endometriosis or Dysuria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.