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Not yet recruitingNCT07931924MiaDIGUpdated Nov 12, 2026

Functional Outcomes of the Miami Pouch Continent Cutaneous Urinary Diversion: A Quality of Life Study

An observational study in Urinary Diversion, Urinary Bladder Carcinoma and Neurogenic Bladder, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Hospices Civils de Lyon · Observational

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
35
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 160 studies in Urinary Bladder Neoplasms with a site in France — 40 open to participants now, 62 under way, 15 of them phase 3. Urinary Bladder Neoplasms · France.

Planned enrollment
25th of 29
35 · median 293
Started
2026
with 7 others
Observational
29 of 160
9 open now
Primary completion
2027-03
later than 23 of 61 live
Registered
160th of 160
by date

Among the 160 studies in Urinary Bladder Neoplasms with a site in France, this one is the 25th largest by planned enrollment of the 29 observational ones that give a count, is one of 8 that started in 2026, is one of 29 observational ones, reaches primary completion later than 23 of the 61 other live ones, and was the 160th registered.

Urinary Bladder Neoplasms

1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.

Browse Urinary Bladder Neoplasms studies →

Open to participants now

40 of the 160 studies in Urinary Bladder Neoplasms with a site in France are open now. Recruiting first, the newest first:

35 more — sign in →

All 40 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The Miami Pouch is a continent cutaneous urinary diversion using the plicated right colon and the ileocecal valve as a catheterizable continent stoma. Despite its long history, functional outcomes remain poorly reported, with no consensus on continence definition or standardized assessment tools.

This single-center cross sectional cohort study evaluates functional outcomes in patients who underwent Miami Pouch urinary diversion at Hôpital Lyon Sud (Hospices Civils de Lyon, France) between 2015 and 2025. Patients were identified through institutional medical coding (PMSI) and contacted by telephone to complete validated patient-reported outcome measures.

The primary objective is to assess stomal continence using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).

Hypothesis: The Miami Pouch provides acceptable long-term stomal continence with limited impact on digestive function.

03

Conditions studied

  • Urinary Diversion
  • Urinary Bladder Carcinoma
  • Neurogenic Bladder
  • Pelvic Malignancy
  • Urinary Incontinence

Keywords

  • Miami Pouch
  • continent cutaneous diversion
  • stomal continence
  • urinary quality of life
  • ICIQ-SF
  • pad test
  • digestive outcomes
  • ileocecal valve
  • radical cystectomy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive patients who underwent Miami Pouch continent cutaneous urinary diversion at the Urology Department of Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France, between 2015 and 2025. 35 patients estimation.

Patients identification through institutional surgical coding (PMSI) and contacted by phone for study participation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged 18 years or older
  • Miami Pouch continent cutaneous urinary diversion performed at Lyon Sud Hospital (HCL) between January 2015 and December 2025
  • Minimum postoperative follow-up of 6 months
  • No opposition to participation in the study

Exclusion criteria

Exclusion Criteria:

  • Patient deceased at time of study contact
  • Patient unreachable or unavailable after three contact attempts
  • Opposition to participation or to personal data processing
  • Postoperative follow-up of less than 6 months
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
35 participants (estimated)
Patient registry
No

Groups and cohorts

  • Miami pouch

    Adult patients who underwent Miami Pouch continent cutaneous urinary diversion at the Urology Department of Hôpital Lyon Sud (HCL) between 2015 and 2025, with a minimum postoperative follow-up of 6 months

    Other: Patient reported outcome measures · Other: 24-Hour Stomal Pad Test

Interventions

  • OtherPatient reported outcome measures

    Patients completed four validated questionnaires by telephone: the ICIQ-SF (urinary symptom frequency and impact), the SF-Qualiveen (urinary quality of life in neurogenic and non-neurogenic patients), a modified 20-item Gastrointestinal Quality of Life Index (digestive quality of life), and the Bristol Stool Scale (stool consistency)

  • Other24-Hour Stomal Pad Test

    Patients performed a self-administered 24-hour stomal pad test at home. Absorbent pads were weighed before and after placement over the stoma. Total pad weight gain (grams) over 24 hours was used as an objective measure of stomal urinary leakage.

06

What researchers measure

Primary outcomes

  1. Stomal Continence Rate

    Stomal continence classified into three categories based on ICIQ-SF questionnaire : * No Leakage * Occasional Leakage * Daily Leakage. Social continence defined as No Leakage or Occasional Leakage.

    Time frame: 6 months post-surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 16, 2026
Primary completionEst.
Mar 16, 2027
CompletionEst.
Apr 16, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931924
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Nov 16, 2026 (estimated)
Primary completion
Mar 16, 2027 (estimated)
Completion
Apr 16, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Théo ARBER, MD
Contact
Theo.Arber@chu-lyon.fr
04 72 67 88 37 ext. +33
Cyril VITARD, MD
Contact
Cyril.vitard@chu-lyon.fr
04 72 67 88 37 ext. +33
ARBER Théo, MD
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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