Mixed Urinary Incontinence Symptoms Before and After Treatment With Botox and Bulkamid

March 11, 2020 updated by: Prof. Dr. Volker Viereck

Prospective, Non-randomized, Single-center Observational Study of Outcome Measures of Patients Suffering From Mixed Urinary Incontinence Before and After Surgical Procedure With Botulinum Toxin and Polyacrylamide Hydrogel (PAHG)

This study compares mixed urinary incontinence symptoms before and after a combined treatment with Botox and Bulkamid. Eligible for the study are adult females with a mixed urinary incontinence, having both urgency urinary symptoms and stress urinary symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Frauenfeld, Switzerland
        • Cantonal Hospital Frauenfeld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with mixed urinary incontinence (MUI) eligible for an intervention with Botox and Bulkamid.

Description

Inclusion Criteria:

  1. Women aged ≥ 18 years.
  2. Clinically diagnosed therapy-refractory mixed urinary incontinence (MUI) based on cough test, urodynamic evaluation, 3-day micturition diary, incontinence-questionnaire with visual analog scales for SUI and UUI.
  3. All criteria for the indication to treat patient with Botox are met.
  4. All criteria for the indication to treat patient with Bulkamid are met.
  5. Participant has given informed consent

Exclusion Criteria:

  1. All contraindications for Bulkamid or Botox
  2. Previous treatment with Botulinum toxin (within last 3 months)
  3. Previous treatment with Bulkamid or other bulking agent (within last 3 months)
  4. Participant is pregnant or lactating
  5. Current urinary tract infection (in which case this has to be treated first before patient might be included)
  6. Residual urine of > 100 ml

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rates for stress urinary incontinence (SUI)
Time Frame: 6 months
Number of participants with negative cough stress test and 90 % improved SUI-visual analog scale.
6 months
Change from baseline in number of micturitions per day
Time Frame: Baseline, 6 months
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of complications
Time Frame: intra-operative and post-operative follow-up up to 12 months
intra-operative and post-operative follow-up up to 12 months
Frequency of cough stress test levels
Time Frame: Baseline, 6 months, 12 months
3 Levels: negative, only a few drops of urine, severe loss of urine
Baseline, 6 months, 12 months
SUI-visual analog scale
Time Frame: Baseline, 6 months, 12 months
Scale from 0-10: 0-no suffering - 10-severe suffering
Baseline, 6 months, 12 months
UUI-visual analog scale
Time Frame: Baseline, 6 months, 12 months
Scale from 0-10: 0-no suffering - 10-severe suffering
Baseline, 6 months, 12 months
Change from baseline in number of micturitions per day
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months
Change from baseline in number of urgency episodes per day
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months
Change from baseline in number of urgency urinary incontinence episodes per 3 days
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months
Change from baseline in urine volume per micturition
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Volker Viereck

Investigators

  • Principal Investigator: Volker Viereck, MD, Cantonal Hospital, Frauenfeld

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Botox-Bulkamid study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication in peer-reviewed journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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