Study Design
This study was designed as a superiority randomized controlled trial, aiming to compare the clinical effectiveness of supervised versus video-assisted pelvic floor muscle training combined with tolterodine therapy.
Participants
Between October 2024 and August 2025, a total of 120 women who presented to the Urology Department of our university hospital and were diagnosed with urge incontinence according to ICS criteria were enrolled. Inclusion criteria were: age 18–60 years and presence of symptoms for at least 3 months. Exclusion criteria were pregnancy, active urinary tract infection, history of pelvic radiotherapy or major pelvic surgery, neurological diseases affecting bladder function (such as multiple sclerosis, spinal cord injury, Parkinson’s disease), severe cardiac failure, and contraindications to tolterodine use. Urge urinary incontinence was diagnosed according to International Continence Society (ICS) criteria, defined as involuntary leakage of urine accompanied by urgency.
Randomization
Participants were randomized into two groups using a computer-generated block randomization method with a block size of four. The randomization sequence was generated by an independent researcher who was not involved in patient recruitment or assessment. Allocation concealment was ensured using sequentially numbered, sealed, opaque envelopes, which were opened only after patient enrollment.
Interventions:
Video Group (n = 60):
Patients in the video-assisted group followed a standardized pelvic floor muscle training protocol demonstrated in an instructional video prepared by a certified physiotherapist. Each training session consisted of 3 sets of 10 repetitions. Each repetition involved a 5-second sustained pelvic floor muscle contraction followed by a 5-second relaxation period. Patients were instructed to perform one session per day, at least five days per week, resulting in a total daily training time of approximately 15 minutes. The program was continued for 16 weeks.
Supervised Group (n = 60):
Patients in the supervised group participated in physiotherapist-led pelvic floor muscle training sessions twice weekly for 16 weeks. Each supervised session lasted approximately 30 minutes and followed the same standardized protocol as the video group (3 sets of 10 repetitions with 5-second contraction and 5-second relaxation). Correct muscle activation, breathing technique, and avoidance of accessory muscle use were actively monitored and corrected by the physiotherapist during each session. All patients received extended-release tolterodine (tolterodine ER) at a dose of 4 mg once daily throughout the 16-week treatment period.
Adherence Assessment
Adherence in the Video group was assessed using patient self-reported exercise logs, which were reviewed during routine outpatient clinic visits at weeks 4, 8, and 16. During these visits, patients were asked to report the frequency and regularity of their home-based exercise sessions. No objective monitoring devices were used. Adherence in the Supervised group was inherently ensured through attendance at scheduled physiotherapist-led sessions
Assessments: The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was administered face-to-face by a trained clinician to all participants at baseline and at the 16-week follow-up visit. Due to the nature of the intervention, blinding of participants and treating physiotherapists was not feasible. The investigator administering the ICIQ-SF questionnaire was not involved in the delivery of the interventions. However, complete blinding of the outcome assessor to group allocation was not feasible and this was considered a methodological limitation of the study.
Adverse events were assessed during scheduled follow-up visits and were also recorded when reported spontaneously by patients. All adverse events were documented using standardized case report forms throughout the study period.
Outcome assessment was performed using a standardized questionnaire applied in a uniform manner to all participants.
Discontinuation due to adverse events was recorded as an intercurrent event and considered in the intention-to-treat analysis.
The study protocol was approved by the Clinical Research Ethics Committee of Van Yüzüncü Yıl University (Approval No: 2024/09–28; Date: October 6, 2024). Written informed consent was obtained from all participants prior to enrollment. All procedures were conducted in accordance with the principles of the Declaration of Helsinki.
Statistical Analysis
Sample size calculation was based on detecting a minimum clinically important difference of 2 points in ICIQ-SF scores between groups, with a statistical power of 80% and a two-sided alpha level of 0.05. Based on previously published randomized controlled trials evaluating supervised versus unsupervised pelvic floor muscle training, the standard deviation of ICIQ-SF scores was assumed to be approximately 3 points, corresponding to an expected moderate effect size (Cohen’s d ≈ 0.65). According to this estimation, a minimum of 52 patients per group was required. To compensate for potential dropouts, a total of 120 patients were recruited. The primary analysis was conducted according to the intention-to-treat (ITT) principle, including all randomized patients. A secondary per-protocol analysis was also performed among patients who completed the intervention as planned.
MATERIAL AND METHODS
Study Design
This study was designed as a superiority randomized controlled trial, aiming to compare the clinical effectiveness of supervised versus video-assisted pelvic floor muscle training combined with tolterodine therapy.
Participants
Between October 2024 and August 2025, a total of 120 women who presented to the Urology Department of our university hospital and were diagnosed with urge incontinence according to ICS criteria were enrolled. Inclusion criteria were: age 18–60 years and presence of symptoms for at least 3 months. Exclusion criteria were pregnancy, active urinary tract infection, history of pelvic radiotherapy or major pelvic surgery, neurological diseases affecting bladder function (such as multiple sclerosis, spinal cord injury, Parkinson’s disease), severe cardiac failure, and contraindications to tolterodine use. Urge urinary incontinence was diagnosed according to International Continence Society (ICS) criteria, defined as involuntary leakage of urine accompanied by urgency.
Randomization
Participants were randomized into two groups using a computer-generated block randomization method with a block size of four. The randomization sequence was generated by an independent researcher who was not involved in patient recruitment or assessment. Allocation concealment was ensured using sequentially numbered, sealed, opaque envelopes, which were opened only after patient enrollment.
Interventions:
Video Group (n = 60):
Patients in the video-assisted group followed a standardized pelvic floor muscle training protocol demonstrated in an instructional video prepared by a certified physiotherapist. Each training session consisted of 3 sets of 10 repetitions. Each repetition involved a 5-second sustained pelvic floor muscle contraction followed by a 5-second relaxation period. Patients were instructed to perform one session per day, at least five days per week, resulting in a total daily training time of approximately 15 minutes. The program was continued for 16 weeks.
Supervised Group (n = 60):
Patients in the supervised group participated in physiotherapist-led pelvic floor muscle training sessions twice weekly for 16 weeks. Each supervised session lasted approximately 30 minutes and followed the same standardized protocol as the video group (3 sets of 10 repetitions with 5-second contraction and 5-second relaxation). Correct muscle activation, breathing technique, and avoidance of accessory muscle use were actively monitored and corrected by the physiotherapist during each session. All patients received extended-release tolterodine (tolterodine ER) at a dose of 4 mg once daily throughout the 16-week treatment period.
Adherence Assessment
Adherence in the Video group was assessed using patient self-reported exercise logs, which were reviewed during routine outpatient clinic visits at weeks 4, 8, and 16. During these visits, patients were asked to report the frequency and regularity of their home-based exercise sessions. No objective monitoring devices were used. Adherence in the Supervised group was inherently ensured through attendance at scheduled physiotherapist-led sessions
Assessments: The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was administered face-to-face by a trained clinician to all participants at baseline and at the 16-week follow-up visit. Due to the nature of the intervention, blinding of participants and treating physiotherapists was not feasible. The investigator administering the ICIQ-SF questionnaire was not involved in the delivery of the interventions. However, complete blinding of the outcome assessor to group allocation was not feasible and this was considered a methodological limitation of the study.
Adverse events were assessed during scheduled follow-up visits and were also recorded when reported spontaneously by patients. All adverse events were documented using standardized case report forms throughout the study period.
Outcome assessment was performed using a standardized questionnaire applied in a uniform manner to all participants.
Discontinuation due to adverse events was recorded as an intercurrent event and considered in the intention-to-treat analysis.
The study protocol was approved by the Clinical Research Ethics Committee of Van Yüzüncü Yıl University (Approval No: 2024/09–28; Date: October 6, 2024). Written informed consent was obtained from all participants prior to enrollment. All procedures were conducted in accordance with the principles of the Declaration of Helsinki.
Statistical Analysis
Sample size calculation was based on detecting a minimum clinically important difference of 2 points in ICIQ-SF scores between groups, with a statistical power of 80% and a two-sided alpha level of 0.05. Based on previously published randomized controlled trials evaluating supervised versus unsupervised pelvic floor muscle training, the standard deviation of ICIQ-SF scores was assumed to be approximately 3 points, corresponding to an expected moderate effect size (Cohen’s d ≈ 0.65). According to this estimation, a minimum of 52 patients per group was required. To compensate for potential dropouts, a total of 120 patients were recruited. The primary analysis was conducted according to the intention-to-treat (ITT) principle, including all randomized patients. A secondary per-protocol analysis was also performed among patients who completed the intervention as planned.