Personalized pudendal nerve stimulation for mixed urinary incontinence and pelvic pain

Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted (Picostim IITM) System

This trial will try personalized pudendal nerve stimulation with an implanted Picostim II device to reduce leakage and pelvic pain in adult women with mixed urinary incontinence who haven't improved with conservative treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 22 Years and up
• Sex: Female
• Sponsor: Amber Therapeutics Ltd (Industry-sponsored)
• Locations: 5 sites (Leuven, Herestraat 49 and 4 other locations)
• Trial ID: NCT06885931 on ClinicalTrials.gov

What this trial studies

This is an exploratory safety and feasibility trial of personalized adaptive pudendal neuromodulation delivered via an implanted Picostim II system for adult women with mixed urinary incontinence and related chronic pelvic pain. Participants will receive implantation of the device and individualized stimulation programming that adapts to their reflex activity, with scheduled follow-up visits to monitor symptoms and safety. Eligible patients must be female (sex at birth), at least 22 years old, mobile, able to use a toilet and the system independently, and have had symptoms for at least six months after failing or not tolerating conservative therapy. Pregnant or breastfeeding patients and those unwilling to use contraception are excluded.

Who should consider this trial

Good fit: Adult women (sex at birth) aged 22 or older with both stress and urge urinary incontinence for at least six months who have failed or cannot tolerate conservative treatments and who can undergo implantation and operate the device are ideal candidates.

Not a fit: Patients who are pregnant, planning pregnancy, breastfeeding, unwilling to use contraception, unable to operate the implanted system, or whose symptoms are unrelated to pudendal nerve pathways may not receive benefit.

Why it matters

Potential benefit: If successful, this approach could offer an adjustable implanted option that reduces both stress and urge leakage and eases chronic pelvic pain for patients who did not benefit from conservative care.

How similar studies have performed: Smaller studies and case series of pudendal neuromodulation have shown promise for incontinence and pelvic pain, but the method is less established than sacral nerve stimulation and larger controlled trials are limited.

Eligibility criteria

Inclusion Criteria:

* Female. NB: the definition of female refers to sex at birth.
* Adult: aged ≥ 22 years (at the time of informed consent signature).
* Patient self-reports both stress and urge episodes (clinician-opinion on history taking).
* Patient has failed to respond to or could not tolerate conservative treatment as determined by the treating health care provider.
* Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date.
* Able and willing to voluntarily sign informed consent form.
* Able to participate in all testing and follow-up clinic visits associated with study protocol.
* Patient is mobile and able to use a toilet.
* In the opinion of the Investigator, the patient is capable of independently using the system components (after training).

Exclusion Criteria:

* Patient is pregnant, breastfeeding, or plans to become pregnant at any time in the future.
* Patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study.
* In the event that patient becomes pregnant during or after the study, they are not prepared to inactivate device for the whole period of the pregnancy.
* Any significant medical condition that, in the opinion of the Investigator, is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints.
* History of major psychiatric or personality disorder.
* Any neurological condition that in the opinion of the investigator may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or complete spinal cord injury).
* Uncontrolled type I or type II diabetes (as defined by their routine care clinician or HBA1C ≥ 7.0).
* History of cancer within 5 years prior to enrolment, except for a cancer that was determined to be free of systemic cancer risk, such as basal cell carcinoma.
* Patient is taking antiplatelet and/or anticoagulant drugs including warfarin or newer alternatives (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) which cannot be paused prior to surgery, or has a bleeding disorder that cannot be corrected prior to surgery.
* Any clinical reason that, in the opinion of the Investigator, may compromise patient's safety during the study.
* Currently participating in another interventional study. This excepts purely observational studies, e.g., registries.
* Patient participation in vigorous physical activities where these cannot be restricted for a period of 6 weeks post-implantation.
* Patient unwilling to stop any future participation in scuba diving below 10m. BMI ≥ 40kg/m2 or waist circumference \> 106cm
* Documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone.
* Skin, orthopedic or neurological anatomical limitations at the site of implant that could prevent successful placement of an electrode or IPG. This includes active perineal sepsis or perianal sepsis (e.g., anal fistula and pilonidal sinus).
* Knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure.
* Implantable neurostimulator or antennae, pacemaker or defibrillator in-situ (anywhere in body).

Where this trial is running

Leuven, Herestraat 49 and 4 other locations

• UZ Leuven — Leuven, Herestraat 49, Belgium (Not_yet_recruiting)
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium (Recruiting)
• Ghent University Hospital — Ghent, Belgium (Recruiting)
• Maastricht UMC — Maastricht, Netherlands (Not_yet_recruiting)
• University College London Hospital — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Amber Clinical Affairs

Conditions Mixed Urinary Incontinence; Stress Urinary Incontinence; Chronic Pelvic Pain