Self-guided pelvic-floor device plus rehab vs standard pelvic rehab for stress incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study compares two approaches for managing stress urinary incontinence in adults aged 18–60. One group receives the current gold-standard pelvic-perineal rehabilitation (15 sessions) while the other uses a pelvic-floor medical device at home three times weekly for 15 minutes over three months, in addition to two in-person rehabilitation sessions. Participants can adjust their home program based on symptoms. The trial is conducted by physiotherapists specializing in pelvic rehabilitation and is sponsored by Nantes University Hospital with collaboration from FIZIMED, recruiting through healthcare professionals. Outcome measures will likely focus on symptom severity and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with moderate, severe or very severe stress urinary incontinence or mixed stress urinary incontinence (according to ICIQ-UI SF questionnaire score: moderate (6-12), severe (13-18) and very severe (19-21))
* Patient aged between 18 and 60
* Patient with a quality of life score measured with the I-QoL questionnaire less than or equal to 70 (score measured from 0 to 100, with poor quality of life: 0-35; average quality of life: 36-70; good quality of life: 71-100)
* Not to have given birth in the last 6 months (to avoid post-partum physiological recovery)
* Signed informed consent
* Effective contraception throughout the study (declarative)
* Patient must have a smartphone running at least Android 7 and iOS 12
* Patient must be able to read and write French

Exclusion Criteria:

* Patients with mild stress urinary incontinence or mixed stress urinary incontinence (ICIQ-UI SF score: mild (1-5))
* Patient with a quality of life score above 70 (according to the I-QoL questionnaire: good quality of life: 71-100)
* Patient undergoing other pelvic-perineal rehabilitation during the study period
* Patients with neurological disease or congenital malformation, surgically or medically treated urinary incontinence or prolapse, perineal hypoesthesia or local conditions prohibiting the use of an intravaginal catheter
* Infection of the bladder or vagina, or any symptoms associated with infection (itching, pain on urination or fever)
* Contraindications to the use of the medical device
* Anatomy making catheter placement difficult or impossible; in the case of prolapse, specialist advice is recommended.
* Hemorrhage
* Patients with genitourinary cancer (within the last 5 years)
* Patients with extra-urethral "incontinence" (fistula, ectopic ureter)
* Patients with severe urinary retention
* Patient with vesico-ureteral reflux
* Patients with hypoactive bladder
* In case of peripheral denervation in the pelvic-perineal area, specialist advice is recommended
* Patients wearing a sacral neuromodulation device
* Patients in an exclusion period (determined by a previous or current study)
* Impossibility of giving the subject clear information (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Patient under court protection
* Patient under guardianship or curatorship
* Pregnancy (positive pregnancy test)
* Breastfeeding (as the hormonal impregnation caused by breastfeeding has a negative impact on perineal tone)
* Use of Huawei and Oppo smartphones

Where it's running

• CHU de Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Thibault THUBERT, PHD
• Email: thibault.thubert@chu-nantes.fr
• Phone: 02.53.48.24.43

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.