Sacral Neuromodulation in Patients With Double Incontinence

NCT07212387 | Not Yet Recruiting

• 1 other identifier: FNO-Urology-DI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study evaluating the effect of a treatment method of sacral neuromodulation (SNM), the use of which is approved and recommended for the treatment of both faecal incontinence (FI) and urinary incontinence (UI). A new aspect of the study is monitoring the effect of SNM in patients with both types of incontinence (faecal and urinary) occurring simultaneously. The study will use diagnostic methods and procedures that are part of the usual examination algorithm. The study will not impose any burden on patients beyond the scope of routine examination and treatment procedures.

Conditions

Double Incontinence; Faecal Incontinence; Urinary Incontinence

Keywords

Double incontinence; Faecal incontinence; Urinary incontinence; Sacral neurostimulation

Outcome Measures

Primary Outcomes (1)

• Overall effect of SNM

  Evaluation of the overall effect of SNM in patients with DI from the patient's perspective using the so-called "patients reported outcome measures" (PROM) with the Patient Global Impression - Improvement questionnaire will be performed.

  18 months

Secondary Outcomes (11)

• The number of responders at the end of the test phase

  2 weeks for the patient, 4 years for the investigator

• Bladder and bowel diary - the number of FI episodes

  3 and 7 days

• Bladder and bowel diary - the number of faecal urgency episodes

  3 and 7 days

• Bladder and bowel diary - the number of UI episodes

  3 and 7 days

• Bladder and bowel diary - the number of urinary urgency episodes

  3 and 7 days

Study Arms (1)

Sacral neuromodulation

EXPERIMENTAL

Female patients with double incontinence (DI) will be enrolled into this study group. The study subjects will undergo sacral neurostimulation (SNM).

Procedure: Sacral neurostimulation

Interventions

Sacral neurostimulation PROCEDURE

Sacral neurostimulation (SNS), or sacral neuromodulation (SNM), is a minimally invasive, reversible treatment for bladder and bowel control problems, including overactive bladder and fecal incontinence.

Sacral neuromodulation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study is intended for female patients with double incontinence only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women over 18 years of age
• Consent to participate in the study
• Willingness to undergo examination, treatment and follow-up according to the protocol
• DI symptoms characterized by:
• Grade III fecal incontinence (patient is unable to consciously hold in wind, loose or hard stools)
• At least 2 episodes of fecal incontinence during the week (according to bladder and bowel diary)
• At least 1 episode of involuntary urine leakage per day (according to bladder and bowel diary)
• Total score of the ICIQ-UI SF questionnaire
• DI symptoms for more than 6 months
• Failure of previous conservative treatment

You may not qualify if:

• Rapidly progressing neurological diseases
• Known severe congenital malformations of the anorectum and/or lower urinary tract
• Presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent
• Pregnancy, lactation
• Active urinary tract infection
• Active malignant disease
• Clinically significant pelvic organ prolapse
• Active inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• In the case of an associated lesion of the external anal sphincter, a defect greater than 90 degrees
• Previous pelvic radiotherapy less than 12 months prior to study enrolment
• Previous pelvic organ descent surgery less than 12 months prior to study enrolment
• Previous stress urinary incontinence surgery less than 12 months prior to study enrolment
• Previous childbirth less than 12 months prior to study enrollment
• Anatomical malformations of the sacrum that preclude implantation of the SNM electrode
• Low patient compliance

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (26)

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MeSH Terms

Conditions

Encopresis; Urinary Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Milan Tesař, MD, Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is being used in the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be enrolled in one experimental group

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)