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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02815046

Enrollment

Registered

2016-06-28

Start date

2016-08-31

Completion date

2019-12-31

Last updated

2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed Incontinence, Urge and Stress

Keywords

urgency urinary incontinence, stress urinary incontinence, Botulinum toxin A, Bulkamid

Brief summary

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.

Interventions

DRUGBotulinum toxin type A

Intravesical injections of Botulinum toxin A (Botox) into the bladder wall.

DEVICEPolyacrylamide hydrogel

Midurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026