Correlation between the dynamic change in the pubis–sling distance and the change in IPSS after TVT surgery – a pilot study (SPINDLE ? Sling–Pubis Interaction and Dynamic Link Evaluation)

Correlation between the dynamic change in the pubis–sling distance and the change in IPSS after TVT surgery – a pilot study (SPINDLE ? Sling–Pubis Interaction and Dynamic Link Evaluation) - SPINDLE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038954

Enrollment

Registered

2026-01-19

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

N39.3

Interventions

Group 1: Participants: Female patients = 18 years of age with a planned TVT procedure due to stress urinary incontinence. Only German-speaking patients (to ensure valid questionnaire assessment). Rou

ultrasound (pubis–sling distance, sling–urethra distance, urethrovesical angle, determination of sling shape)

IPSS questionnaire approx. 20 minutes Three months postoperatively: repetition of measurements

IPSS questionnaire approx. 20 minutes Total duration per patient: 3 months Total study duration: approx. 24 months Data sources: medical records, ultrasound images, IPSS questionnaire.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Women aged 18–80 years with a planned retropubic TVT procedure Preoperative post-void residual urine = 100 mL Ability to provide informed consent Participation in routine postoperative follow-up

Exclusion criteria

Exclusion criteria: Exclusion criteria: Clinically relevant postoperative post-void residual urine (> 100 mL) Need for sling loosening or re-operation Neurological disorders affecting micturition Pregnancy Lack of informed consent History of sling surgery or major urethral surgery Current treatment with unstable anticholinergic or ß3-agonist medication

Design outcomes

Primary

Measure	Time frame
Primary objective: To investigate the correlation between the percentage change in the pubis–sling distance during the Valsalva maneuver and the change in IPSS (?IPSS; International Prostate Symptom Score) after TVT surgery. Primary endpoint: Correlation between the percentage change in the pubis–sling distance (%) under Valsalva and ?IPSS after TVT surgery. Hypothesis: A greater decrease in the pubis–sling distance correlates with an increase in IPSS (r = 0.40).	—

Measure

Time frame

Primary objective: To investigate the correlation between the percentage change in the pubis–sling distance during the Valsalva maneuver and the change in IPSS (?IPSS; International Prostate Symptom Score) after TVT surgery. Primary endpoint: Correlation between the percentage change in the pubis–sling distance (%) under Valsalva and ?IPSS after TVT surgery. Hypothesis: A greater decrease in the pubis–sling distance correlates with an increase in IPSS (r = 0.40).

—

Secondary

Measure	Time frame
Secondary endpoints: Postoperative sling–urethra distance / Dynamic change in the urethrovesical angle during Valsalva Association between preoperative and postoperative parameters and subjective voiding symptoms Reliability of ultrasound measurements (ICC) Exploratory: determination of a ?IPSS cut-off indicating functional obstruction	—

Countries

Germany

Contacts

Public ContactYaman Degirmenci

Universitätsmedizin Mainz - Frauenklinik

Yaman.Degirmenci@unimedizin-mainz.de06131 17-11

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026