Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Some Parametrs of Men With Urinary Frequency
Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Urinary Frequency, Pelvic Floor Function, and Post-Void Residual Volume in Men With Urinary Frequency: A Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Study Design:
Prospective Single-center Parallel-group 1:1 randomized Assessor-blinded RCT CONSORT-compliant
Inclusion Criteria:
Male Age 18-65 years Complaint of urinary frequency persisting for at least 3 months
On a 3-day bladder diary:
≥8 voids/24 hours Provision of written informed consent Sufficient cognitive capacity to learn pelvic floor muscle contraction
Exclusion Criteria:
Active urinary tract infection Prostate cancer Prostate surgery within the last 12 months
Neurological diseases:
Parkinson's disease Multiple sclerosis (MS) Stroke Spinal cord injury Neurogenic bladder due to diabetes mellitus Bladder stones Bladder tumor Urethral stricture
Within the last 3 months:
PFMT (pelvic floor muscle training) Biofeedback PTNS (percutaneous tibial nerve stimulation) Tibial nerve stimulation Recent dose change in antimuscarinic or β3-agonist therapy Randomization Computer-generated block randomization Block size of 4 or 6 Allocation concealment Sealed opaque envelopes
Assessment Time Points T0 = Baseline T1 = Week 6 T2 = Week 12 T3 = 6-month follow-up Primary Outcome 3-day bladder diary 24-hour voiding frequency
Secondary Outcomes OAB-V8 Symptom severity ICIQ-OAB Quality of life and symptom impact PGI-I Patient global impression of improvement
Ultrasound Measurements A) Pelvic Floor Muscle Strength Transabdominal ultrasound
During maximum voluntary contraction:
Bladder neck elevation (mm) 3 repetitions Average will be calculated
B) Pelvic Floor Muscle Endurance Following maximum contraction 10-second hold Duration of bladder neck elevation maintenance or Percentage of elevation maintained over 10 seconds
C) Post-Void Residual Volume (PVR) Via ultrasound Within the first 5 minutes after voiding Recorded in mL
Interventions Group 1 Bladder Training Urge suppression strategies Extending voiding intervals Fluid management Caffeine education ● (placeholder/bullet) Pelvic Floor Muscle Training 8 weeks
1 face-to-face session per week Home exercise program Fast contractions: 10 reps × 3 sets Maximal (sustained) contractions: 10 reps × 10 seconds each Functional contractions: To be performed when urgency is felt
Group 2 Bladder training only Same follow-up frequency Same training duration
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hasan Bingöl, Assoc. Prof, PhD
- Telefonnummer: 5595 +90 0(426) 216 0012
- E-post: hesenbingol@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Male sex
- Age 18-65 years
- Complaint of urinary frequency persisting for at least 3 months
- On a 3-day bladder diary: ≥8 voids per 24 hours
- Provision of written informed consent Sufficient cognitive capacity to learn pelvic floor muscle contraction (assessed by clinical judgment)
Exclusion Criteria:
- Active urinary tract infection
- Prostate cancer
- Prostate surgery within the last 12 months
- Parkinson's disease, Multiple sclerosis (MS), Stroke, Spinal cord injury
- Neurogenic bladder due to diabetes mellitus
- Bladder stones, Bladder tumor, Urethral stricture
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group 1: Intervention group
Bladder Training + Pelvic Floor Muscle Training
|
Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption.
The pelvic floor muscle training component involves three types of contractions: fast contractions (10 repetitions, 3 sets), maximal sustained contractions (10 repetitions, held for 10 seconds each), and functional contractions integrated into daily activities to improve real-life muscle control.
|
|
Aktiv komparator: Group 2: Control group
Group 2: Bladder Training Alone
|
Bladder training includes strategies for suppressing urgency, gradually extending the intervals between voiding, managing fluid intake, and reducing caffeine consumption
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pelvic floor muscle strength as assessed by ultrasound
Tidsramme: From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Carralero-Martinez A, Munoz Perez MA, Kauffmann S, Blanco-Ratto L, Ramirez-Garcia I. Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: A randomized controlled trial. Neurourol Urodyn. 2022 Apr;41(4):962-972. doi: 10.1002/nau.24903. Epub 2022 Mar 9.
- Siegel AL. Pelvic floor muscle training in males: practical applications. Urology. 2014 Jul;84(1):1-7. doi: 10.1016/j.urology.2014.03.016. Epub 2014 May 10.
- Clemens JQ, Nadler RB, Schaeffer AJ, Belani J, Albaugh J, Bushman W. Biofeedback, pelvic floor re-education, and bladder training for male chronic pelvic pain syndrome. Urology. 2000 Dec 20;56(6):951-5. doi: 10.1016/s0090-4295(00)00796-2.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2026/06-24.06.2026
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