An Open Label Perspective Clinical Study To Evaluate Composite Effect Of Uttarbasti With Urethral Dilatation in The Management of Urethral Stricture

Urethral stricture (Mutramarga Sankocha) is a chronic and recurrent narrowing of the urethral lumen due to fibrotic changes, leading to difficulty in micturition, straining, dribbling, and other lower urinary tract symptoms (LUTS). Conventional treatments such as urethral dilatation, Visual Internal Urethrotomy (VIU), and urethroplasty are often invasive and prone to recurrence. Ayurveda describes similar conditions under Mutrakruccha and Mutrotsanga, where Uttarbasti is mentioned as a prime therapeutic approach. The present open-labelled, single-arm, prospective clinical study is designed to evaluate the composite effect of Uttarbasti with Tila Taila (Sesamum indicum) in combination with urethral dilatation in the management of urethral stricture. The study will be conducted in the Department of Shalya Tantra, Parul Institute of Ayurved, Parul University, Vadodara, Gujarat. Thirty patients fulfilling inclusion and exclusion criteria will receive Uttarbasti with 50 ml of sterile Tila Taila administered per urethra once daily for 15 days, along with urethral dilatation on the 5th, 7th, 9th, and 11th days. The primary objective is to evaluate the composite efficacy of Uttarbasti with urethral dilatation, while the secondary objectives are to assess safety, tolerability, and patient satisfaction. The effect will be assessed subjectively using patient-reported outcome measures (PROMs) and objectively through Retrograde Urethrogram (RGU) and uroflowmetry before and after treatment. The total study duration will be 60 days, including treatment and follow-up on the 30th and 60th day.