The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT02924740
• Date of registration: 29/09/2016
• Prospective Registration: Yes
• Primary sponsor: Hacettepe University
• Public title: The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
• Scientific title: The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
• Date of first enrolment: October 2016
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02924740
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium, Turkey

Contacts

• Name: Türkan Akbayrak, PhD
• Affiliation: Hacettepe University

Key inclusion & exclusion criteria

Inclusion Criteria:

- having symptoms of SUI according to MESA urinary incontinence questionnaire; age>18
and < 65 years; having the ability of pelvic floor muscle contraction, being free of
UI medications for at least 4 weeks before the start of the study; and sufficient
literacy to complete required forms and urinary diaries and perform training
protocols.

Exclusion Criteria:

- antenatal or postnatal women (up to 3 months after delivery), women with persistent
urinary tract infections, impaired mental state, Stage 3 and 4 pelvic organ prolapse
(POP), neurological disorders, and who received concurrent or recent physiotherapy
intervention (within the last year).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Stress Urinary Incontinence

Intervention(s)

Behavioral: Pelvic Floor Muscle Training

Behavioral: Vaginal Tampon Training

Primary Outcome(s)

Global rating of improvement [Time Frame: change from baseline subjective improvement at 12 weeks]

Secondary Outcome(s)

Incontinent episodes [Time Frame: change from baseline incontinent episodes at 12 weeks]

Frequency of micturition [Time Frame: change from baseline subjective improvement at 12 weeks]

Pelvic floor muscle endurance (PFME) [Time Frame: change from baseline pelvic floor muscle endurance at 12 weeks]

Pelvic floor muscle strength (PFMS) [Time Frame: change from baseline pelvic floor muscle strength at 12 weeks]

Severity of urinary incontinence [Time Frame: change from baseline severity of incontinence at 12 weeks]

Secondary ID(s)

GO 16/506-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors